History Of Allergic Conjunctivitis Research Articles

Prevalence of symptomatic dry eye and influencing factors among Chinese adolescents: A cross-sectional study.

Comprehensive research on the impact of various types of refractive errors (RE) and anisometropia on dry eye disease is still lacking. This study aimed to estimate the prevalence rates and potential lifestyle factors related to symptomatic dry eye (SDE) among adolescents in eastern China. A cross-sectional study was performed in 2023, and a stratified cluster sampling technique was used among adolescents in Nantong, China. Demographic information, including sex, age and BMI, were collected. All participants underwent optometric tests, while Ocular Surface Disease Index (OSDI) and self-designed questionnaires were administered. Both univariate and multivariate logistic regression analyses were used to assess associations between SDE and related parameters, and various types of RE and anisometropia were also included in the study. A total of 1,518 participants were enrolled in the study, and the overall prevalence of SDE was 20.3% among adolescents in Nantong, China. Multiple logistic regression analyses showed that high myopia (aOR = 3.42, 95% CI = 1.60-3.36, p = 0.025), frequent use of eye drops (aOR = 2.31, 95% CI = 1.60-3.36, p<0.001), a history of allergic conjunctivitis (aOR = 1.93, 95% CI = 1.09-3.34, p = 0.025), and frequent blinking (aOR = 3.23, 95% CI = 2.31-4.53, p<0.001) were identified as risk factors for SDE. Conversely, male gender (aOR: 0.76, 95% CI: 0.58-0.99, p = 0.043), increased sleep time (6-7 h: aOR = 0.64, 95% CI = 0.46-0.89, p = 0.009; 7-8 h: aOR = 0.64, 95% CI = 0.43-0.95, p = 0.026; >8 h: aOR = 0.43, 95% CI = 0.23-0.82, p = 0.010), and timely intervention when vision decline occurred were protective factors against SDE (aOR = 0.61, 95% CI = 0.43-0.85, p = 0.004). High myopia was found to be independently associated with an increased risk of SDE., while hyperopia, astigmatism, and anisometropia were not independent risk factors for SDE. The identified risk and protective factors may help provide valuable insights for future research and interventions aimed at improving ocular health in adolescents.

Clinical characteristics and outcomes of ocular allergy in Thai children.

Allergic conjunctivitis (AC) is the most common ocular condition in allergic children. In tropical countries, the study about the clinical features and outcome of treatment is very limited. To review clinical characteristics and outcomes of treatment in children with ocular allergy. Children with history of AC were classified to seasonal allergic conjunctivitis (SAC), perennial allergic conjunctivitis (PAC), vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC). The clinical history and outcome of treatment were recorded. One hundred and sixty-four children were recruited. PAC was the most common type (61.6%), followed by SAC (21.3%), VKC (12.2%), and AKC (4.9%). Male preponderance was found in all groups. Mean age of onset was 6.8 ? 2.8 years. Allergic rhinitis was the most common co-morbidity (97.6%). The common sensitized allergen is house-dust mites (86.1%). Standard treatments in all groups were natural tear and topical olopatadine. Add-on medications were usually needed in severe types of AC (VKC, AKC). History of topical corticosteroid use was 68.8% and 12.5% in VKC and AKC, respectively. All of them can discontinue topical corticosteroid when topical tacrolimus was applied. The overall remission was found 35% in VKC group and 63% in AKC group. The median duration of treatment was 20.5 months in VKC group and 11 months in AKC group. most Thai children with AC sensitized to house-dust mites. In severe forms of AC, most patients needed addon medication. The use of topical calcineurin inhibitor as an add-on therapy can decrease the use of topical corticosteroid.

Dupilumab ocular side effects in patients with atopic dermatitis: a systematic review.

Atopic dermatitis (AD) is a chronic, inflammatory skin disorder that most frequently occurs in children, but it can also affect adults. Even though most AD cases can be managed with topical treatments, moderate-to-severe forms require systemic therapies. Dupilumab is the first human monoclonal antibody approved for the treatment of AD. Its action is through IL-4 receptor alpha subunit inhibition, thus blocking IL-4 and IL-13 signaling pathways. It has been shown to be an effective, well-tolerated therapy for AD, as well as for asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), and eosinophilic esophagitis (EoE). However, an increasing incidence of dupilumab-induced ocular surface disease (DIOSD) has been reported in patients treated with dupilumab, as compared to placebo. The aim of this study was to summarize scientific data regarding DIOSD in AD patients treated with dupilumab. A search of PubMed and clinicaltrials.gov databases was performed. There was no limit to study design. All AD cases were moderate-to-severe. DIOSD was either dermatologist-, allergist-, or ophthalmologist-assessed. Evidence shows that DIOSD occurs most frequently in patients with atopic dermatitis and not in other skin conditions, neither in patients with asthma, CRSwNP, nor EoE who are on dupilumab treatment. Further studies are warranted in order to establish a causal relationship between dupilumab and ocular surface disease. Nevertheless, ophthalmological evaluations prior to dupilumab initiation can benefit AD patients with previous ocular pathology or current ocular symptomatology. Also, patch testing for ocular allergic contact dermatitis might be advantageous in patients with a history of allergic conjunctivitis. Furthermore, TARC, IgE, and circulating eosinophils levels might be important biomarkers for a baseline assessment of future candidates to dupilumab treatment. However, TARC measurements should be resumed for research purposes only.

One-year real-world clinical effectiveness, safety, and laboratory safety of dupilumab in Japanese adult patients with atopic dermatitis: A single-center retrospective study

One-year real-world clinical effectiveness, safety, and laboratory safety of dupilumab in Japanese adult patients with atopic dermatitis: A single-center retrospective study

Risk of allergic conjunctivitis in patients with type 1 diabetes mellitus: a population-based retrospective cohort study

ObjectiveIn accordance with the dichotomy between T helper type 1(Th1) and T helper type 2 (Th2) responses, the occurrence of allergic conjunctivitis (AC) and type 1 diabetes mellitus (T1DM) is,...

Risk factors for ocular surface squamous neoplasia in Kenya: a case-control study.

ObjectiveTo determine modifiable risk factors of ocular surface squamous neoplasia (OSSN) in Kenya using disease‐free controls.MethodsAdults with conjunctival lesions were recruited at four eye care centres in Kenya and underwent excision biopsy. An equal number of controls having surgery for conditions not affecting the conjunctiva and unrelated to ultraviolet light were group‐matched to cases by age group, sex and eye care centre. Associations of risk factors with OSSN were evaluated using multivariable logistic regression to estimate odds ratios (ORs) and 95% confidence intervals (95% CIs). Continuous variables were compared using the t‐test or the Wilcoxon–Mann–Whitney U‐test depending on their distribution.ResultsA total of 131 cases and 131 controls were recruited. About two‐thirds of participants were female, and the mean age of cases and controls was 42.1 years and 43.3 years, respectively. Risk factors for OSSN were HIV infection without antiretroviral therapy (ART) use (OR = 48.42; 95% CI: 7.73–303.31) and with ART use (OR = 19.16; 95% CI: 6.60–55.57), longer duration of exposure to the sun in the main occupation (6.9 h/day vs. 4.6 h/day, OR = 1.24; 95% CI: 1.10–1.40) and a history of allergic conjunctivitis (OR = 74.61; 95% CI: 8.08–688.91). Wearing hats was protective (OR = 0.22; 95% CI: 0.07–0.63).ConclusionMeasures to prevent and control HIV, reduce sun exposure such as wearing hats and control allergic conjunctivitis are recommended.

Integrated phase III trials of bepotastine besilate ophthalmic solution 1.5% for ocular itching associated with allergic conjunctivitis

Allergic conjunctivitis is a clinical reaction to environmental allergens and is manifested by ocular itching caused by IgE-induced mast cell degranulation. Bepotastine besilate is a selective H(1)-antagonist with mast cell stabilizing properties. This report examines the reduction of ocular itching integrated from two conjunctival allergen challenge (CAC) clinical trials comparing bepotastine besilate ophthalmic solution (BBOS) 1.5% to placebo in subjects with a history of allergic conjunctivitis. Two phase III, double-masked, placebo-controlled, parallel-group, CAC clinical trials evaluated BBOS 1.5% versus placebo to reduce ocular itching. Eligible subjects were randomly assigned 1:1 to either BBOS 1.5% (n = 78) or placebo (n = 79). Ocular itching was graded by subjects using a standardized scale (0–4 U). Adverse events and ophthalmic clinical findings were recorded for safety. BBOS 1.5% was superior to placebo for reducing CAC-induced ocular itching (p < 0.0001) as early as 3 minutes post-CAC and for at least 8 hours after dosing. Post hoc analyses examining several populations also showed a significant improvement (p < 0.0001) for subjects with more severe itching response at screening and for the proportion of subjects with complete or nearly complete resolution of CAC-induced itching, both outcomes supporting the clinical benefit of BBOS 1.5%. Adverse events were generally transient and mild. BBOS 1.5% is safe and effective in the treatment of ocular itching associated with allergic conjunctivitis within 3 minutes of a CAC and with a sustained duration of action of at least 8 hours. (ClinicalTrials.gov numbers: NCT00424398 and NCT00586664).

Use of In Vivo Confocal Microscopy to Assess Allergic Inflammation following Conjunctival Allergen Challenge

In this study, we used confocal microscopy following conjunctival allergen challenge (CAC) to track the progress of the acute allergic response and the subsequent ocular late phase inflammation. Imaging data provided the basis for development of a reproducible scale for assessment of late phase allergy. Patients (10) with history of allergic conjunctivitis were enrolled in this pilot study. The ocular surface of subjects was imaged before (as a baseline) and after a single CAC, conducted according to established protocols. Confocal images were captured at regular intervals from 3 minutes to 180 minutes post-challenge using a Nidek Confoscan scanning confocal microscope. Image analysis was used to develop a scale for extent of inflammatory cell infiltration. Clinical symptoms were scored in parallel to imaging. This scale was then used to score individual subjects (in a blinded fashion) to provide numerical comparators to baseline measures. Conjunctival Allergen Challenge (CAC) caused a significant increase in cellular infiltration compared to baseline. While the sample size was small, comparison of all measured parameters suggests that the late-phase scales accurately reflect the subject symptomology. The use of in vivo confocal microscopy has great potential to aid clinical diagnosis of anterior segment diseases. This study represents an important step in development of usable metrics to assess the time course and extent of allergic ocular inflammation. Scales developed in this study should be useful in diagnosing presence of allergic disease and in assessing disease severity as well as therapeutic efficacies of potential treatments.

Conjunctival sac bacterial flora isolated prior to cataract surgery

ObjectiveTo determine the trends of conjunctival sac bacterial flora isolated from patients prior to cataract surgery.Subjects and methodsThe study comprised 579 patients (579 eyes) who underwent cataract surgery. Specimens were collected by lightly rubbing the inferior palpebral conjunctival sac with a sterile cotton swab 2 weeks before surgery, and then cultured for isolation of bacteria and antimicrobial sensitivity testing. The bacterial isolates and percentage of drug-resistant isolates were compared among age groups and according to whether or not patients had diabetes mellitus, hyperlipidemia, dialysis therapy, oral steroid use, dry eye syndrome, or allergic conjunctivitis.ResultsThe bacterial isolation rate was 39.2%. There were 191 strains of Gram-positive cocci, accounting for the majority of all isolates (67.0%), among which methicillin-sensitive coagulase-negative staphylococci was the most frequent (127 strains, 44.5%), followed by methicillin-resistant coagulase-negative staphylococci (37 strains, 12.7%). All 76 Gram-positive bacillary isolates (26.7%) were from the genus Corynebacterium. Among the 16 Gram-negative bacillary isolates (5.9%), the most frequent was Escherichia coli (1.0%). The bacterial isolation rate was higher in patients >60 years old, and was lower in patients with dry eye syndrome, patients under topical treatment for other ocular disorders, and patients with hyperlipidemia. There was no significant difference in bacterial isolation rate with respect to the presence/absence of diabetes mellitus, steroid therapy, dialysis, or a history of allergic conjunctivitis. Methicillin-resistant coagulase-negative staphylococci showed a significantly higher detection rate in diabetic patients than nondiabetic patients (20.3% versus 7.0%, P < 0.05). The percentage of all isolates resistant to levofloxacin, cefmenoxime, and tobramycin was 14.0%, 15.2%, and 17.9%, respectively, with no significant differences among these drugs.ConclusionThe high bacterial isolation rate in patients >60 years old and the high methicillin-resistant coagulase-negative staphylococci isolation rate in patients with diabetes are important to consider for prevention of perioperative infections.

Prolonged Effectiveness of Bepotastine Besilate Ophthalmic Solution for the Treatment of Ocular Symptoms of Allergic Conjunctivitis

This clinical trial evaluated the safety and effectiveness of bepotastine besilate ophthalmic solutions 1.0% and 1.5% compared with placebo for the treatment of ocular itching and conjunctival hyperemia (redness) using the conjunctival allergen challenge (CAC) model of allergic conjunctivitis when dosed 16 h before a CAC test. Subjects with a history of allergic conjunctivitis were assigned to receive placebo or bepotastine besilate ophthalmic solution 1.0% or 1.5% in a single-center, randomized, placebo-controlled clinical trial. Eligible subjects (n=107) aged 10 years and older with a history of allergic conjunctivitis who had a reproducible positive reaction to a CAC were enrolled and dosed with test agent. The primary trial objectives included assessment of ocular itching and conjunctival redness at 16 h after instillation of test agent. Reductions in several CAC-induced secondary symptoms and signs of allergic conjunctivitis were also evaluated for tearing, ciliary and episcleral redness, eyelid swelling, chemosis, and mucous discharge. Bepotastine besilate ophthalmic solution 1.5% demonstrated clinical effectiveness and statistical significance in comparison to placebo for the reduction in CAC-induced ocular itching 16 h after drug administration. Bepotastine besilate ophthalmic solution 1.0% also achieved statistical significance in comparison to placebo for reducing ocular itching at all time points 16 h after dosing. Statistically significant reduction (P≤0.05) was additionally seen in this CAC test for the secondary ocular efficacy variable of allergen-induced tearing for bepotastine besilate ophthalmic solution 1.5%. No clinical benefit was seen for reducing the coprimary efficacy variable of conjunctival redness with the CAC model of allergic conjunctivitis. Bepotastine besilate ophthalmic solution 1.5% produced predefined clinically meaningful reduction in CAC-induced ocular itching and tearing in a single-site trial and was more effective than bepotastine besilate ophthalmic solution 1.0% and placebo for reducing ocular itching in a CAC test 16 h after dosing.

The safety and efficacy of alcaftadine 0.25% ophthalmic solution for the prevention of itching associated with allergic conjunctivitis

Objective:The purpose of this study was to evaluate the safety and clinical efficacy of alcaftadine 0.25% ophthalmic solution, a new topical anti-allergic agent for the prevention of the signs and symptoms of allergic conjunctivitis induced by conjunctival allergen challenge (CAC).Study design and methods:This two-arm, double-masked, multi-center, placebo-controlled Phase III study (NCT00889330) enrolled healthy volunteers (N = 58) with a history of allergic conjunctivitis. Subjects ≥10 years of age with a reproducible, positive reaction to a CAC were randomized to receive either one drop of alcaftadine 0.25% ophthalmic solution bilaterally or vehicle bilaterally. After 16 hours (Visit 3) and 15 minutes (Visit 4), a CAC was performed and ocular and nasal symptoms of allergy were graded over a 20-minute period. Clinical and statistical significance were evaluated.Main outcome measures:The primary endpoints were ocular itching and conjunctival redness. The secondary endpoints were all other signs and symptoms of allergic conjunctivitis. Visual acuity, slit lamp biomicroscopy and adverse event reporting were the predetermined safety measures.Results:Alcaftadine was effective in the prevention of ocular itching based on both clinically relevant and statistically significant differences compared with vehicle (placebo). Alcaftadine significantly reduced conjunctival redness, and almost all other allergic signs and symptoms at both 15 minutes and 16 hours after drug administration. No significant safety issues were reported. Between-group differences in ocular itching were higher 16 hours after drug administration than at 15 minutes after drug administration.Conclusions:With an onset of action within 3 minutes and a duration of action of at least 16 hours, the statistically and clinically significant effect of alcaftadine 0.25% on itching make it an important addition to therapy for ocular allergy. Additional studies are warranted to better understand the mechanisms affording a fast onset and prolonged duration of action.

Efficacy and safety of a new ophthalmic preservative‐free formula of levocabastine 0.05% during a conjunctival allergen challenge

Abstract Purpose To evaluate the efficacy and safety of preservative‐free levocabastine 0.05% ophthalmic solution (PFL) compared to preserved levocabastine 0.05% ophthalmic suspension (PL) and vehicle of the solution in the prevention of allergic conjunctivitis induced by a conjunctival provocation test (CPT). Methods 92 healthy volunteers with a history of allergic conjunctivitis were randomized in this double‐masked study. 69 subjects received 1 drop of PFL in 1 eye and 1 drop of PL in the fellow eye, either 10 min [visit 3 (V3)] or 4 h [visit 4 (V4)] prior to CPT. 23 subjects received 1 drop of PFL in 1 eye and 1 drop of vehicle in the fellow eye, either 10 min or 4 h prior to CPT. The primary endpoint was the sum score of itching and redness assessed 3, 5 and 10 min after CPT at V3 and at V4. Other evaluations included tolerance, corresponding to study drug drop sensation and adverse events. Results PFL was shown to be statistically superior to vehicle (p ≤ 0.01) at all time points with one exception at V4, 3 min after CPT. Sum scores varied from 0.7 to 1.6 with PFL and from 1.2 to 2.7 with vehicle. PFL was shown to be statistically superior to PL at V3 and non‐inferior at V4. At V3, the sum scores varied from 0.7 to 1.6 with PFL and from 1.2 to 2 with PL. At V4, sum scores varied from 1.1 to 1.7 with PFL and from 0.9 to 1.7 with PL. Upon instillation, PFL was better tolerated than PL (p&lt;0.001). No serious adverse events were recorded. Conclusion The efficacy of the preservative‐free solution of levocabastine is superior to the effect of the vehicle and, at V3, superior to the efficacy of the preserved suspension of levocabastine. The preservative‐free solution was better tolerated than the preserved suspension. Commercial interest

Bepotastine besilate ophthalmic solution for the relief of nonocular symptoms provoked by conjunctival allergen challenge

Bepotastine besilate is a selective histamine1-receptor antagonist and mast cell stabilizer with inhibitory effects on eosinophilic activity. To evaluate the safety and efficacy of 1.5% bepotastine besilate ophthalmic solution in alleviating nonocular symptoms induced by a conjunctival allergen challenge (CAC), a clinical model of allergic conjunctivitis. This was a single-center, double-masked, randomized, placebo-controlled clinical trial performed from March 1 to April 4, 2007. Patients 10 years or older with a history of allergic conjunctivitis and a reproducible, positive, clinical response to a CAC were eligible. Patients received either placebo or 1.5% bepotastine besilate, 1 drop in each eye. After 15 minutes, 8 hours, or 16 hours after dosing, a CAC was performed and patients evaluated nonocular symptoms using standardized grading scales. Seventy-one patients were enrolled in the study, and 66 comprised the per protocol population. A clinically meaningful reduction (> or = 1.0 unit) compared to placebo was achieved for rhinorrhea and nasal congestion at most time points after 1.5% bepotastine besilate instillation at 8 hours before a CAC test. Significant reductions (P < or = .05) in mean values were seen with 1.5% bepotastine besilate at 15 minutes and 8 hours after dosing for CAC-induced nasal congestion, rhinorrhea, ear or palate pruritus, nasal pruritus, and summed nonocular composite symptom (NOCS) scores and also at 16 hours after dosing for nasal congestion and rhinorrhea. The 1.5% bepotastine besilate formulation produced statistically significant reductions after a CAC in individual nonocular symptoms and NOCS scores at onset of allergic response and for at least 8 hours after instillation, with the greatest reduction seen for nasal congestion and rhinorrhea.

Time to onset and duration of action of the antihistamine bepotastine besilate ophthalmic solutions 1.0% and 1.5% in allergic conjunctivitis: A phase III, single-center, prospective, randomized, double-masked, placebo-controlled, conjunctival allergen challenge assessment in adults and children

Background: Bepotastine besilate is a highly selective histamine H 1-receptor antagonist with antihistaminic, mast cell stabilizing, and anti-inflammatory activity. Based on a history of clinical effectiveness and tolerability of oral bepotastine besilate in the treatment of allergic symptoms, bepotastine besilate is being tested as a potential ophthalmic medication for allergic conjunctivitis. Objective: The aim of this study was to assess the effects of bepotastine besilate ophthalmic solution 1.0% and 1.5% for the treatment of ocular itching and conjunctival hyperemia in a conjunctival allergen challenge (CAC) model in adults and children. Methods: This Phase III, single-center, prospective, randomized, double-masked, placebo-controlled, CAC clinical trial enrolled patients ≥10 years of age with a history of allergic conjunctivitis, skin-test reaction, and CAC response. Patients received bepotastine besilate ophthalmic solution 1.0%, bepotastine besilate ophthalmic solution 1.5%, or placebo, 1 drop on each eye on days 14 ± 3 and 28 ± 3. The primary efficacy end points, patient-assessed ocular itching (at 3, 5, and 7 minutes) and investigator-assessed conjunctival hyperemia (at 7, 15, and 20 minutes), were determined after CAC according to standardized 5-point scales (0 = none to 4 = severe). Clinical significance was defined in the protocol as ≥1.0-U between-group difference in mean ocular itching scores at the majority of time points at a study visit and also a ≥0.5-U difference at all time points. Tolerability of the test agent was assessed by visual acuity, slit-lamp biomicroscopy, intraocular pressure, dilated funduscopy, and adverse events. Results: A total of 107 patients (male, 54%; age range, 11–73 years; white race/ethnicity, 93%) received investigational product and comprised the intent-to-treat (ITT) population (bepotastine besilate ophthalmic solution 1.0%, 36 patients; bepotastine besilate ophthalmic solution 1.5%, 35; and placebo, 36). All 107 patients received investigational product at visit 3A (day 0) and were included in the ITT population. Of the 107 patients who were enrolled, 103 completed the study without a protocol deviation or violation. The 1.0% and 1.5% solutions were associated with clinically and statistically significant reductions in mean ocular itching scores compared with placebo on the 15-minute onset-of-action and 8-hour duration-of-action CAC tests (reductions, 1.3–1.5 U and 1.0–1.7 U respectively; all, P < 0.001). Statistically significant reductions in conjunctival hyperemia were achieved with both bepotastine besilate concentrations. Overall, 13 patients experienced a treatmentemergent adverse event considered related to the study drug (bepotastine besilate ophthalmic solution 1.0%, 6 patients; bepotastine besilate ophthalmic solution 1.5%, 4; and placebo, 3). Conclusions: In this CAC model of allergic conjunctivitis in adults and children, bepotastine besilate ophthalmic solutions 1.0% and 1.5% were associated with clinically and statistically significant reductions in ocular itching, but not conjunctival hyperemia, within 15 minutes that were maintained for at least 8 hours after administration. Both solutions were well tolerated. ClinicalTrials.gov identifier: NCT00424398.

Allergic Conjunctivitis and Latent Infections

The purpose of this study was to evaluate in a large series the incidence of latent infection during chronic allergic conjunctivitis. In a 5-year follow-up prospective, nonrandomized trial, we evaluated 236 patients (472 eyes) with a history of allergic conjunctivitis but without evidence of infection. Conjunctival scrapings were examined cytologically, and antibiograms and antimicrograms were assessed. The 472 eyes were divided into 5 subgroups based on the percent of eosinophilic cells in conjunctival specimens. Latent concurrent infection was identified in 176 of 472 eyes (37%): Candida albicans (55.2%), Staphylococcus epidermidis (50.9%), Chlamydia trachomatis (30.7%), and Staphylococcus aureus (23%). The incidence of concurrent infection (mainly bacterial infection) strongly correlated with the percent of eosinophilic cells. Concurrent bacterial infection was identified in 26 of 26 cases of the subgroup with the highest percent of eosinophilic cells. Chronic allergic conjunctivitis may be associated with latent infection. Pathogens can stimulate activation of eosinophils with a consequent worsening and chronicity of allergic symptoms.

Epinastine 0.05% Ophthalmic Solution in Contact Lens-Wearing Subjects With a History of Allergic Conjunctivitis

To assess the comfort and efficacy of epinastine 0.05% ophthalmic solution in contact lens wearers with a history of allergic conjunctivitis and contact lens intolerance during allergy season. One hundred forty-six subjects were enrolled in a multicenter, open-label study. Enrolled subjects instilled rewetting drops twice a day for a one-week run-in period, then were randomized to epinastine 0.05% twice a day plus rewetting drops as required (n = 75) or rewetting drops alone as required (minimum use twice a day) (n = 71). Subjects recorded the length of time that contact lens wear was comfortable, the total time of wear, ocular itch, overall comfort, and use of rewetting drops during the run-in period, at baseline, and on days 2 to 7 of the treatment period. Subjects averaged 34 years of age; 79% were female. No significant differences were shown at baseline between subjects treated with epinastine 0.05% twice a day plus rewetting drops and control subjects treated with rewetting drops alone. Averaged over the treatment period, epinastine provided significant increases in comfortable wearing time (1.33 +/- 2.89 vs. 0.43 +/- 2.28 hr, P=0.012) and total wearing time (0.35 +/- 1.87 vs. -0.32 +/- 1.81 hr, P=0.008) compared with controls. Epinastine users reported less frequent additional rewetting drop use on average by 0.56 uses per day, which was significantly different than controls (reduction of 0.06 uses per day; P=0.012). Epinastine provided significantly greater improvements from baseline in ocular itch and overall eye comfort compared with rewetting drops alone (P<or=0.001). Epinastine 0.05% may be useful for the treatment of seasonal allergic conjunctivitis in contact lens wearers.

Ocular comfort and drying effects of three topical antihistamine/mast cell stabilizers in adults with allergic conjunctivitis: A randomized, double-masked crossover study

Objective: The aim of this study was to compare short-term (5-minute) ocular comfort and drying effects of 3 topical antihistamine/mast cell stabilizers—epinastine, azelastine, and ketotifen—in patients with allergic conjunctivitis (AC). Methods: Adults with a history of AC, as confirmed on skin testing conducted within the previous 2 years, were enrolled in this single-center, randomized, doublemasked crossover study. At visit 1, patients were randomized to receive a single drop of epinastine in 1 eye and either azelastine or ketotifen in the other eye. Ocular comfort was assessed by patients on an 11-point scale (0 = very comfortable to 10 = very uncomfortable) immediately (0 minute) and at 0.5, 1, 2, and 5 minutes after instillation. Patients were also asked to describe how their eyes felt at 3 minutes using a standardized list of positive ( soothing, smooth, refreshing, cool, and comfortable), neutral ( thick, sticky, and filmy), and negative ( stinging, irritating, and burning) descriptor words. At visits 2 to 4, patients were examined for ocular drying and tear-film stability using fluorescein staining and ocular protection index (OPI) evaluation, respectively. Results: A total of 40 patients (27 women, 13 men; mean age, 40 years [range, 18-73 years]) were included in the study. The mean comfort score was significantly lower (indicating more comfort) with epinastine compared with azelastine at 0.5, 1, 2, and 5 minutes (between-treatment differences, 2.90, 1.85, 1.35, and 0.63, respectively; P < 0.001, P < 0.001, P = 0.001, and P = 0.019) and compared with ketotifen immediately after instillation (between-treatment difference, 1.2; P = 0.014). The mean ocular comfort score was significantly lower with ketotifen compared with azelastine at 0.5, 1, and 2 minutes (between-treatment differences, 2.35, 1.35, and 1.10, respectively; P = 0.001, P = 0.023, and P = 0.028). A majority (85%) of patients chose positive comfort descriptors to describe epinastine versus 34% with azelastine. No significant differences in fluorescein staining or OPI were observed. Conclusions: In this small study in patients with AC, following administration of a single drop, epinastine was rated as more comfortable than azelastine and ketotifen. None of the tested medications were associated with significant acute ocular drying effects.

Efficacy of olopatadine ophthalmic solution 0.2% in reducing signs and symptoms of allergic conjunctivitis

Olopatadine hydrochloride ophthalmic solution 0.2% (Pataday, Alcon) is a new formulation of olopatadine hydrochloride ophthalmic solution, the first topical ocular antiallergic agent indicated for once-daily dosing. The aim of this study was to evaluate the safety, efficacy, onset, and duration of action of olopatadine 0.2% in the treatment of allergic conjunctivitis. Using the conjunctival allergen challenge, this double-masked, randomized by eye, parallel-group study included four visits over a 5-week period. Subjects were screened for eligibility (visit 1) and their ocular allergic responses were confirmed at visit 2. The efficacy of olopatadine in reducing the signs and symptoms of allergic conjunctivitis was evaluated at onset of action (visit 4) and 16 hours (visit 3) after masked medication instillation. The primary efficacy parameter was ocular itching. Safety parameters were also evaluated. Ninety subjects were evaluated. Olopatadine 0.2% was significantly (p < 0.001) more effective than placebo in the treatment of ocular itching at all time points at both the onset of action and the 16-hour allergen challenges. Olopatadine 0.2% was significantly (p < 0.03) more effective than placebo in the reduction of conjunctival redness, chemosis, and eyelid swelling at all time points (with the exception of conjunctival redness, which was significantly reduced at five of six time points). There were no serious adverse events and no treatment-related adverse events. Once-daily dosing with olopatadine 0.2% reduced the signs and symptoms of allergic conjunctivitis with a rapid and prolonged duration of action. Safety analyses indicated that olopatadine 0.2% was safe and well tolerated in subjects with a history of allergic conjunctivitis.

Comparative efficacy of olopatadine 0.1% ophthalmic solution versus levocabastine 0.05% ophthalmic suspension using the conjunctival allergen challenge model

SUMMARYObjective: To compare the efficacy of olopatadine and levocabastine in reducing ocular allergic itching and vascular hyperemia (redness) induced by conjunctival allergen challenge.Research design and methods: The study was a randomized, double-masked, contralateral study using the conjunctival allergen challenge (CAC) model. At Visit 1, subjects with a positive allergen skin test and a history of allergic conjunctivitis were administered increasing concentrations of allergen until at least a moderate grade 2 ocular itching and conjunctival redness response was obtained in both eyes. Allergic signs were graded on standardized 0–4 scales. Subjects who reacted positively were re-challenged at Visit 2 with the pre-determined concentration of allergen. Subjects who again responded with at least a grade 2 bilateral ocular itching and conjunctival redness score at Visit 2 were eligible for drug evaluation. At Visit 3, subjects received olopatadine in one eye and levocabastine in the contralateral eye according to a computer-generated randomization scheme generated prior to commencement of the study. Ocular discomfort was then graded in both eyes. Subjects were bilaterally challenged with the predetermined concentration of allergen 27 min after topical drug administration, such that the first post-challenge assessment was made 30 min post-drug instillation. Allergic signs and symptoms were evaluated at 3 min, 10 min, and 20 min post-challenge and safety and efficacy analyses were performed.Results: Sixty-eight subjects received study drug and were included in the safety and efficacy analyses. Ocular itching scores for olopatadine were significantly lower than levocabastine at 3 min and 10 min post-challenge ( p < 0.001). Ocular redness scores for olopatadine were significantly lower than levocabastine at all time points post-challenge ( p < 0.0001). Of all subjects, 4.41% reported ocular discomfort in the olopatadine eye and 26.5% in the levocabastine treated eye.Conclusion: Olopatadine treated eyes had significantly less itching and redness than levocabastine treated eyes after conjunctival allergen challenge. Olopatadine was also associated with less discomfort upon instillation than levocabastine.

Clinical efficacy of olopatadine vs epinastine ophthalmic solution in the conjunctival allergen challenge model

SUMMARYBackground: Olopatadine hydrochloride 0.1% ophthalmic solution (Patanol*) and epinastine hydrochloride 0.05% ophthalmic solution (Elestat†) are two topical antiallergic agents. Olopatadine is indicated for the treatment of the signs and symptoms of allergic conjunctivitis that include itching, redness, tearing, lid swelling, and chemosis. Epinastine is indicated for the prevention of itching associated with allergic conjunctivitis.Objective: This study compared the clinical efficacy of olopatadine and epinastine in the prevention of itching and conjunctival redness in the conjunctival allergen challenge (CAC) model.Research design and methods: This was a prospective, randomized, double-masked, contralaterally-controlled, single center allergen challenge study. Ninety-six subjects with a history of allergic conjunctivitis were screened, and the 66 who responded to conjunctival allergen challenge at visits 1 and 2 were randomized into 1 of 3 treatment groups at visit 3 to receive one drop of study medication in each eye: (1) olopatadine in one eye and epinastine in the fellow eye, (2) olopatadine in one eye and placebo in the fellow eye, and (3) epinastine in one eye and placebo in the fellow eye. Five minutes after study drop instillation, subjects were bilaterally challenged with the allergen concentration that had elicited a positive conjunctival allergic response at Visits 1 and 2. Subjective itching assessments were given at 3 min, 5 min, and 7 min post challenge. Objective redness and chemosis assessments were made at 10 min, 15 min, and 20 min post challenge. Paired sample two-tailed t-tests were performed on the mean scores at each time point to assess statistical significance in the differences between treatments.Main outcome measures; results: Fifty-three subjects were randomized into the olopatadine/epinastine treatment group, the primary analysis group. Olopatadine treated eyes exhibited significantly lower mean itching and conjunctival redness scores than the contralateral epinastine treated eyes, –0.19 ( p = 0.003) and –0.52 ( p < 0.001), respectively. Olopatadine treated eyes also exhibited significantly less chemosis –0.24 ( p < 0.001), ciliary redness –0.55 ( p < 0.001), and episcleral redness –0.58 ( p < 0.001) than epinastine treated eyes.Conclusion: Olopatadine is significantly more effective than epinastine in controlling itching, redness and chemosis associated with allergic conjunctivitis in the CAC model.* Patanol is a registered tradename of Alcon Laboratories Inc, Forth Worth, TX, USA