Bulbar Conjunctival Injection Research Articles

P31 Eyeing up: dupilumab-associated ocular surface disease in children with eczema in a tertiary paediatric hospital in London

Abstract Dupilumab blocks interleukin (IL)-4 and IL-13 and has demonstrated significant clinical benefit in eczema. Dupilumab-associated ocular-surface disease (DAOSD) has been described in adults but literature on the paediatric population is scarce. We conducted a retrospective review of electronic patient records of patients receiving dupilumab for eczema from April 2019 to July 2022. Outcome measures included incidence of DAOSD, patient/drug-related risk factors, ocular signs and symptoms, time to develop DAOSD, severity and treatments. Forty-six patients (median age 12 years, range 9–14) were identified; of these 12 (26%) developed DAOSD. Only one patient (8.3%) had pre-existing eye disease. The median time to DAOSD development was 3 (1–9) months. All patients were referred to ophthalmology, nine have been reviewed and three are awaiting appointments. All but one was symptomatic with ocular irritation (92%). In the nine patients reviewed by ophthalmology, ocular signs included bilateral bulbar conjunctival injection (n = 9, 100%), follicles (limbal or forniceal, n = 4, 44%), diffuse tarsal–conjunctival thickening (n = 3, 33%), cicatrization (n = 2, 22%). Four patients (44%) had moderate eye findings with peripheral corneal opacification; the symptoms were not always proportionate to the signs. The remaining five patients had mild ocular findings. Topical treatment for DAOSD included protopic to eyelid (n = 1), ciclosporin (n = 2), steroid (n = 4), lubrication (n = 5) and chloramphenicol (n = 2). No patients stopped treatment because of DAOSD. DAOSD in this cohort was higher than that reported in RCTs with similar timeframe to DAOSD development. Almost half of our patient cohort had moderate DAOSD but were only mildly symptomatic. No DAOSD predictive factors were identified.

Millet-Seed Tarsal Conjunctivitis in Eyelid Sarcoid.

A 59-year-old female with known cardiac and pulmonary sarcoidosis was referred for progressive right upper eyelid ptosis and thickening after right dacryocystorhinostomy 2 years ago (panel A). The examination was significant for right upper eyelid ptosis, bulbar conjunctival injection, forniceal symblepharon, and nonvisible puncta. Eyelid eversion revealed diffuse conjunctival hyperemia and yellow “millet-seed”-like nodules (panel B). She underwent a right upper eyelid full-thickness biopsy owing to concerns for malignancy. Histopathology demonstrated chronic conjunctivitis with noncaseating granulomas consistent with sarcoid (panel C). A regimen of oral prednisone, mycophenolate mofetil, and dapsone resulted in improvement of tarsal conjunctivitis, nodularity, and ptosis (panel D). The most common ocular manifestation of sarcoidosis is uveitis (30%–70%). Conjunctival involvement is also common (40%) and usually manifests as conjunctival nodules comprised of noncaseating granulomas. It is important for ophthalmologists to be aware of the ocular manifestations of sarcoidosis as they may be the first sign of systemic disease.

Treatment trials for viral conjunctivitis: what we have learned and how we can improve.

Treatment trials for viral conjunctivitis: what we have learned and how we can improve.

Intravenous immunoglobulin for the treatment of Kawasaki disease.

Intravenous immunoglobulin for the treatment of Kawasaki disease.

Developing a Deep Learning Model to Evaluate Bulbar Conjunctival Injection with Color Anterior Segment Photographs.

The present research aims to evaluate the feasibility of a deep-learning model in identifying bulbar conjunctival injection grading. Methods: We collected 1401 color anterior segment photographs demonstrating the cornea and bulbar conjunctival. The ground truth was bulbar conjunctival injection scores labeled by human ophthalmologists. Two convolutional neural network-based models were constructed and trained. Accuracy, precision, recall, F1-score, Kappa, and the area under the curve (AUC) were calculated to evaluate the efficiency of the deep learning models. The micro-average and macro-average AUC values for model grading bulbar conjunctival injection were 0.98 and 0.98, respectively. The deep learning model achieved a high accuracy of 87.12%, a precision of 87.13%, a recall of 87.12%, an F1-score of 87.07%, and Cohen's Kappa of 0.8153. The deep learning model demonstrated excellent performance in evaluating the severity of bulbar conjunctival injection, and it has the potential to help evaluate ocular surface diseases and determine disease progression and recovery.

Ocular surface disease index questionnaire as a sensitive test for primary screening of chronic ocular graft-versus-host disease.

BackgroundAfter allogeneic hematopoietic stem cell transplantation (allo-HSCT), patients are followed up by transplant clinicians. Finding an effective primary screening method that transplant clinicians or patients can master is essential in the early referral of suspected chronic ocular graft-versus-host disease (coGVHD) to an ophthalmologist. This study investigated if the ocular surface disease index (OSDI) questionnaire could be used for coGVHD primary screening.MethodsThis case-controlled, cross-sectional study enrolled 161 allo-HSCT patients. All participants completed an OSDI questionnaire and underwent a silt-lamp examination. Bulbar conjunctival injection (BCI) was assessed using torchlight, while tear volume was measured via the Schirmer test (ST). The receiver operating characteristic curve was used to evaluate the sensitivity, specificity, and cutoff values of OSDI, ST, and BCI grading. Performance comparisons of the 3 tests applied in isolation, parallel, and series were made.ResultsThere were 84 patients with and 77 patients without coGVHD. Compared to those without coGVHD, patients with coGVHD had significantly higher median values of OSDI, corneal fluorescein staining, conjunctival injection, conjunctival fibrosis, and meibum quality, but lower ST scores (All P values <0.001). The cutoff values for OSDI, ST, and BCI grade in the diagnosis of coGVHD were 19.4 points, 7 mm, and grade 0, respectively. The sensitivity and specificity of the tests based on the cutoff values were, respectively, 89.3% and 89.6% for OSDI, 91.7% and 59.7% for ST, and 78.6% and 70.1% for BCI. The area under the curve (AUC) value of OSDI was significantly higher than that of ST (0.931 vs. 0.826; P=0.010) and BCI grade (0.931 vs. 0.781; P<0.001). The AUC values of the combinations were lower than that of OSDI alone.ConclusionsThe OSDI questionnaire can be used as a simple screening test for coGVHD as demonstrated by its high sensitivity and specificity in the transplant clinic and patients’ self-monitoring. An OSDI greater than 19.4 could be considered an ophthalmology referral criterion.

An atypical case of Kawasaki disease with severe pneumonia in a neonate

BackgroundKawasaki disease (KD) is an acute, febrile, systemic vasculitis of unknown etiology that primarily affects the coronary arteries and generally occurs at around 1 year of age. Although the diagnosis of KD is generally not difficult, it is challenging in cases of incomplete KD lacking characteristic clinical manifestations. The incidence of incomplete KD is higher in infants younger than 6 months of age. Pneumonia is an extremely rare complication of KD and can be misinterpreted as atypical pneumonia rather than KD. Herein, we report a neonate with atypical KD and severe pneumonia who required mechanical ventilation.Case presentationJapanese one-month-old infant had only fever and rash on admission (day 1), and he was transferred to the intensive care unit for severe pneumonia on day 2. Although pneumonia improved following intensive care, he was diagnosed with KD on day 14 because of emerging typical clinical manifestations such as fever, bulbar nonexudative conjunctival injection, desquamation of the fingers, and coronary artery aneurysm. KD symptoms improved after three doses of intravenous immunoglobulin plus cyclosporine. However, small coronary aneurysms were present at the time of discharge. In a retrospective analysis, no pathogens were detected by multiplex real-time PCR in samples collected at admission, and the serum cytokine profile demonstrated prominent elevation of IL-6 as well as elevation of neopterin, sTNF-RI, and sTNF-RII, which suggested KD.ConclusionsThe patient’s entire clinical course, including the severe pneumonia, was caused by KD. As in this case, neonatal KD may exhibit atypical manifestations such as severe pneumonia requiring mechanical ventilation.

A 10-year cross-sectional retrospective study on Kawasaki disease in Iranian children: incidence, clinical manifestations, complications, and treatment patterns

BackgroundKawasaki disease (KD) as an acute, systemic vasculitis is the leading cause of acquired heart disease in children under the age of 5 years.MethodsA 10-year cross-sectional retrospective study was designed to assess 190 Iranian children with KD during 2008–2018. Demographic data, clinical and laboratory manifestations from the onset of symptoms to diagnosis, clinical signs and symptoms, and subsequent treatments were evaluated to predict hospitalization stay, complications, and response to treatment.ResultsChildren with KD had a male-to-female ratio of 1.18:1 and an average age of 36 months. There was an insignificantly more incidence of KD in cold seasons. The most frequent symptoms were fever (92.6%), oral mucus membrane changes (75.8%), bilateral bulbar conjunctival injection (73.7%), polymorphous skin rash (73.2%), peripheral extremity changes (63.7%), and cervical lymphadenopathy (60.0%). The rate of gastrointestinal, cardiac, joint, and hepatic complications was determined to be 38.4, 27.9, 6.8, and 4.2%, respectively. 89.5% of patients received intravenous immunoglobulin (IVIG) plus aspirin as the first line of treatment, while, 16.3% of them needed an extra second line of treatment. Significantly low serum sodium levels and high platelet counts were detected in KD patients with cardiac complications. Cardiac complications often were more encountered in patients who did not respond to the first line of treatment. Higher platelet count, lower serum sodium amount, and C-reactive protein (CRP) level were significantly associated with a need for an additive second line of treatment. A significant relationship between hospitalization stay and hemoglobin level was found.ConclusionAs most of the clinical manifestations and complications were following other reports released over the past few years, such data can be confidently used to diagnose KD in Iran. Seasonal incidence and a positive history of recent infection in a notable number of patients may provide clues to understand possible etiologies of KD. Laboratory markers can successfully contribute to health practitioners with the clinical judgment of the need for additional treatments, possible complications, and hospitalization duration.

What paediatricians need to know about the updated 2017 American Heart Association Kawasaki disease guideline

Kawasaki disease (KD), a systemic vasculitis, is the leading cause of acquired heart disease in industrialised countries. Despite decades of research, the aetiology and pathogenesis remain unclear. Prompt diagnosis and...

Clinical and Antibacterial Efficacy and Safety of Besifloxacin Ophthalmic Suspension Compared With Moxifloxacin Ophthalmic Solution.

To evaluate the efficacy of besifloxacin ophthalmic suspension 0.6% compared with moxifloxacin ophthalmic solution 0.5% in the treatment of bacterial conjunctivitis in an Indian population. Multicenter, randomized, double-masked, active-controlled, parallel-group, clinical trial, including 6 clinical sites in India. Patients were randomized to receive 1 drop of besifloxacin or moxifloxacin in the infected eye(s), 3 times daily, for 5 days. Primary efficacy end points included clinical resolution and bacterial eradication at day 5. Secondary efficacy end points included clinical resolution and bacterial eradication at day 8, ocular discharge, bulbar conjunctival injection, investigator's global assessment, and bacterial eradication by species. Efficacy was analyzed using the Cochran-Mantel-Haenszel and Pearson χ2 tests. Safety was assessed by the incidence of ocular and nonocular treatment-emergent adverse events (AEs), changes in visual acuity, and biomicroscopy and ophthalmoscopy findings. Data presented are that for the subset of patients from India. Of the 123 patients randomized at clinical sites in India, 96.7% completed the study. Day 5 differences in microbial eradication (100% besifloxacin vs 96.3% moxifloxacin) and in clinical resolution (78.9% besifloxacin vs 71.4% moxifloxacin) were not statistically significant. No statistically significant between-group differences were observed for secondary end points. All ocular AEs in both groups were mild or moderate in severity. There were no drug-related ocular AEs with besifloxacin. Treatment of bacterial conjunctivitis with besifloxacin 0.6% produces similar antibacterial and clinical efficacy as that with moxifloxacin 0.5% in an Indian population, with no clinically meaningful safety concerns.

Efficacy and Safety of Topical Atorvastatin for the Treatment of Dry Eye Associated with Blepharitis: A Pilot Study

Aims: To elucidate if topically applied atorvastatin safely decreases corneal fluorescein staining in dry eyes associated with blepharitis. Methods: Ten dry eye and blepharitis (DEB) patients were enroled in a prospective pilot study. All patients were treated with topical atorvastatin (50 μ<smlcap>M</smlcap>) 8 times a day for 4 weeks and allowed to continue with their existing dry eye treatment. The patients were examined weekly for 4 weeks. The primary outcome measure was corneal fluorescein staining. Secondary outcome measures were tear film break-up time (BUT), Schirmer I testing, blepharitis score and bulbar conjunctival injection. The subjective efficacy was evaluated with global symptom and facial analogue scores. Results: An improvement in corneal fluorescein staining in the treated eye by >1 point from baseline to completion of the trial at week 4 was found in 9 of 10 patients (p < 0.01). Topical atorvastatin significantly improved the tear film BUT (p < 0.01), blepharitis score (p < 0.05) and bulbar conjunctival injection (p < 0.05). The global symptom score and facial analogue score also improved (p < 0.05). There were no side effects. Conclusion: Topical atorvastatin is a potential therapy for DEB patients. Larger comparative clinical studies are required to establish the efficacy and safety of topical atorvastatin.

Efficacy and safety of azithromycin 1.5% eye drops in paediatric population with purulent bacterial conjunctivitis

ObjectiveTo determine the efficacy and safety of azithromycin 1.5% eye drops in a paediatric population with purulent bacterial conjunctivitis.Patients and methodsThis was a multicentre, international, randomised, investigator-masked study in 286...

Loteprednol Etabonate Suspension 0.2% Administered QID Compared With Olopatadine Solution 0.1% Administered BID in the Treatment of Seasonal Allergic Conjunctivitis: A Multicenter, Randomized, Investigator-Masked, Parallel Group Study in Chinese Patients

BackgroundSeasonal allergic conjunctivitis (SAC) is caused by seasonal allergens and usually manifests as ocular itching and bulbar conjunctival injection (redness). Treatment options for SAC include corticosteroids and dual-acting antihistamine and mast-cell stabilizers. ObjectiveOur objective was to compare the efficacy and tolerability of loteprednol etabonate (LE), a C-20 ester-based corticosteroid, with those of olopatadine, a dual-acting antihistamine mast-cell stabilizer, in Chinese patients. MethodsThis was a multicenter, randomized, investigator-masked, parallel group study. Patients with acute SAC experiencing grade 4 ocular itching and grade 2 or higher bulbar conjunctival injection received either LE suspension 0.2% QID at 4-hour intervals or olopatadine solution 0.1% BID at 6- to 8-hour intervals bilaterally for 15 days. Primary efficacy end points included the change from baseline (CFB) in ocular itching and bulbar conjunctival injection at day 15. The primary analysis tested the noninferiority of LE suspension 0.2% to olopatadine solution 0.1%. Tolerability outcomes included the incidence of adverse events (AEs), biomicroscopy findings, visual acuity, and intraocular pressure. ResultsA total of 300 patients were randomly assigned, and 293 were included in the per-protocol population (LE, n = 147; olopatadine, n = 146). Mean (SD) CFB at day 15 in the LE and olopatadine treatment groups, respectively, was −3.74 (0.47) and −3.28 (0.91) for ocular itching and −1.91 (0.52) and −1.71 (0.59) for bulbar conjunctival injection. The 95% CI for the differences in CFB in ocular itching (−0.59 to −0.27) and bulbar conjunctival injection (−0.27 to −0.08) was less than the prespecified noninferiority limit of 0.3. Treatment differences in CFB were significantly better with LE compared with olopatadine for both end points (P ≤ 0.0006). Ocular AEs were few and similar between treatment groups. There were no clinically significant biomicroscopy or visual acuity findings, and no patient experienced a clinically significant increase in intraocular pressure (≥10 mm Hg). ConclusionResults of this investigator-masked study with Chinese patients suggest LE suspension 0.2% was noninferior to olopatadine solution 0.1% for the treatment of SAC. Both LE suspension 0.2% and olopatadine solution 0.1% were well tolerated. ClinicalTrials.gov identifier: NCT01435460.

Besifloxacin Ophthalmic Suspension 0.6% Administered Twice Daily for 3 Days in the Treatment of Bacterial Conjunctivitis in Adults and Children

Besifloxacin ophthalmic suspension 0.6% given thrice daily for 5 days is safe and effective in the treatment of patients with bacterial conjunctivitis. This study evaluated the safety and efficacy of besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days compared with vehicle in the treatment of bacterial conjunctivitis. This was a multicenter, double-masked, randomized, vehicle-controlled, parallel-group study. A total of 474 patients aged ≥1 year with bacterial conjunctivitis were randomized in a 1 : 1 ratio to receive either besifloxacin ophthalmic suspension 0.6% or vehicle administered twice daily for 3 days. There were three study visits: day 1 (the baseline visit), day 4/5 (visit 2), and day 7 ± 1 (visit 3). The co-primary efficacy endpoints were bacterial eradication and clinical resolution at day 4/5 in designated study eyes of patients with culture-confirmed bacterial conjunctivitis. Secondary efficacy endpoints were bacterial eradication and clinical resolution at day 7 ± 1, individual clinical outcomes of ocular discharge and bulbar conjunctival injection at all visits; and microbial and clinical outcomes for overall bacterial species and individual Gram-positive and Gram-negative bacterial species at each follow-up visit. Safety endpoints included adverse events (AEs), changes in visual acuity and biomicroscopy findings at each visit, and changes in ophthalmoscopy findings at day 7 ± 1. Bacterial eradication and clinical resolution rates were significantly higher in the besifloxacin group than in the vehicle group (115/135 [85.2%] vs 77/141 [54.6%], p < 0.001, and 89/135 [65.9%] vs 62/141 [44.0%], p < 0.001, respectively) at day 4/5. Rates of bacterial eradication continued to be significantly greater in the besifloxacin group (115/135 [85.2%] vs 91/141 [64.5%], respectively; p < 0.001) at day 7 ± 1; however, the rates of clinical resolution did not differ significantly between the groups (103/135 [76.3%] and 94/141 [66.7%], p = 0.209) at this visit. Ocular discharge and bulbar conjunctival injection at each visit were consistent with the primary outcomes. Clinical resolution and bacterial eradication with Gram-positive or Gram-negative organisms were consistent with the overall findings. All AEs in both groups were of mild or moderate severity and were considered unrelated to the treatment. Treatment with besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days was effective and safe in adults and children with bacterial conjunctivitis. Registered at ClinicalTrials.gov as NCT00972777.

361 Giant Papillary Conjuntivitis without Associated Triggers. Report of Two Cases

BackgroundGiant papillary conjunctivitis is associated with soft and rigid contact lens wearing, ocular prostheses, exposed sutures, extruded scleral buckle, filtering blebs, band keratopathy, corneal foreign bodies, limbal dermoids, and cyanoacrylate tissue adhesives. Patients present decreased lens tolerance, increased lens movement and awareness, mucus, irritation, redness, burning, and itching. Is bilateral and 10% unilateral. The upper tarsal conjunctiva shows inflammation, papules >0.3 mm, bulbar conjunctival injection, superior corneal pannus or opacities. Fluorescein noted papillary reaction. Histopathology: Mast cells, basophils and eosinophils were found in the epithelium and substantia propia. Histamine, Ig, IgG, IgM, C3, Factor B, C3 anaphylatoxin, Eotaxin, Neutrophilic chemotactic factor elevated in tears. Lactoferrin is decreased. Pathophysiology: The cause is unknown, factors as immunologic disease, mechanical trauma or irritation influence. Contact lenses become coated that serves as an antigen so the increased proteins in the tear film result in further coating. Treatment: Nonsteroidal anti-inflammatory agents, topical mast cell stabilizers or mast cell stabilizer-antihistamines. Replacement lenses at 2 weeks to 3 months. Daily lens disinfection with hydrogen peroxide and unpreserved saline solution. Severe should stop wearing their contact lenses for >4 weeks or refit with rigid gas-permeable lenses.MethodsA 7 year-old female presents 6 months ago redness, pruritus, forgein body sensation, eyelid inflammation without improvement with treatments. On examination with conjunctival hyperemia, hypertrophy of papillae and epiphora.A 22 year-old male presents at 7 years old conjunctival burning, foreign body sensation, conjunctival hyperemia, hyaline secretion treated with topical antibiotics and steroids with minimal and temporal improvement. On examination, conjunctival hyperemia, giant papillae on superior tarsal bilateral predominantly left. Stool negative.ResultsWe found 2 patients affected without common triggers and early onset of severe clinical manifestations and refractory to usual treatment.ConclusionsWe present 2 clinical cases of unusual presentation since both of them were pediatric presentation and Giant papillary conjunctivitis has its peak of incidence in the adult population. Besides, both patients lacked an initial trigger such as contact lens wearing or ophthalmologic surgery. Both of them had a poor response to treatment. This disease should be considered in pediatric population and start treatment inmediately to avoid complications such as loss of vision.

Besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis patients with Pseudomonas aeruginosa infections

BackgroundThe purpose of this study was to determine the efficacy of besifloxacin ophthalmic suspension 0.6% when used in the treatment of bacterial conjunctivitis infections due to Pseudomonas aeruginosa.MethodsWe undertook a post hoc analysis of clinical outcomes in patients with bacterial conjunctivitis due to P. aeruginosa across four prospective, multicenter, double-masked, randomized, controlled, clinical studies of besifloxacin ophthalmic suspension 0.6%. Efficacy outcomes included bacterial eradication and clinical resolution of the baseline infection at follow-up visits. Bacterial eradication was defined as the absence of ocular bacterial species present at or above threshold at baseline, while clinical resolution was defined as grade 0 ocular discharge and bulbar conjunctival injection. Safety outcomes included the incidence of adverse events, changes in visual acuity, and biomicroscopy and ophthalmoscopy findings. Patient outcomes were summarized and bacterial eradication and clinical resolution rates integrated.ResultsOf 1317 patients with culture-confirmed bacterial conjunctivitis across four clinical studies, nine (0.7%) were infected with P. aeruginosa at baseline, and of these, five were randomized to treatment with besifloxacin ophthalmic suspension 0.6%. Bacterial eradication of the baseline infection was observed at both follow-up visits in all five patients. Clinical resolution was achieved in two of five patients by the first follow-up visit and four of five patients by the second follow-up visit. There were no adverse events reported in these patients. There were no clinically meaningful biomicroscopy findings or changes in ophthalmoscopy or visual acuity.ConclusionThe incidence of bacterial conjunctivitis due to P. aeruginosa was low. Treatment of patients with P. aeruginosa infections with besifloxacin ophthalmic suspension 0.6% led to bacterial eradication of P. aeruginosa by the first follow-up visit and high rates of clinical resolution.

Hearing loss, uveomeningitis, and stroke in a 55‐year‐old man

Hearing loss, uveomeningitis, and stroke in a 55‐year‐old man

Efficacy and Tolerability of Besifloxacin Ophthalmic Suspension 0.6% Administered Twice Daily for 3 Days in the Treatment of Bacterial Conjunctivitis: A Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group Study in Adults and Children

BackgroundBesifloxacin is a topical fluoroquinolone with potent in vitro activity against a broad spectrum of ocular pathogens, including drug-resistant strains. Besifloxacin ophthalmic suspension 0.6% given 3 times daily for 5 days has been reported to be more effective than its vehicle in the treatment of bacterial conjunctivitis. Pharmacokinetic/pharmacodynamic modeling suggests that besifloxacin might also be effective given twice daily. ObjectiveThis study evaluated the efficacy and tolerability of besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days compared with vehicle (formulation without besifloxacin) in the treatment of adults and children with bacterial conjunctivitis. MethodsThis was a multicenter, prospective, randomized, double-masked, vehicle-controlled, parallel-group study. Patients aged ≥1 year with bacterial conjunctivitis were randomized to receive besifloxacin ophthalmic suspension or vehicle administered twice daily for 3 days. There were 3 study visits: the baseline visit, visit 2 (day 4 or 5), and visit 3 (day 7±1). Participants recorded the times of medication instillation in a patient diary. The primary end points were clinical resolution and bacterial eradication of the baseline bacterial infection at visit 2 in patients with culture-confirmed bacterial conjunctivitis. Secondary end points were clinical resolution and bacterial eradication of the baseline bacterial infection at visit 3, individual clinical outcomes (ocular conjunctival discharge and bulbar conjunctival injection) at the follow-up visits, and microbial and clinical outcomes for overall bacterial species and individual gram-positive and gram-negative bacterial species. Tolerability assessments included ocular adverse events (AEs), changes in visual acuity, biomicroscopy and ophthalmoscopy findings, and nonocular AEs. ResultsOf 202 patients randomized to treatment (mean [SD] age, 25.2 [24.3] years; 56.9% female; 76.7% white), 109 had culture-confirmed bacterial conjunctivitis (53 besifloxacin ophthalmic suspension, 56 vehicle). At visit 2, the besifloxacin ophthalmic suspension group had significantly greater rates of clinical resolution compared with the vehicle group (37/53 [69.8%] vs 21/56 [37.5%], respectively; P < 0.001), as well as significantly greater rates of bacterial eradication (46/53 [86.8%] vs 32/56 [57.1%]; P < 0.001). At visit 3, rates of bacterial eradication were also significantly greater in the besifloxacin ophthalmic suspension group compared with the vehicle group (46/53 [86.8%] vs 39/56 [69.6%]; P = 0.038). Results for the individual clinical outcomes and microbial and clinical outcomes by gram-positive and gram-negative species were consistent with the primary efficacy outcomes. The incidence of ocular AEs did not differ significantly between treatment groups (4/94 [4.3%] vs 8/98 [8.2%]). Ocular AEs in all treated eyes in the respective groups included bacterial conjunctivitis (3/157 [1.9%] and 5/154 [3.2%]), conjunctivitis (3/157 [1.9%] and 4/154 [2.6%]), and allergic conjunctivitis (2/157 [1.3%] and 1/154 [0.6%]). These events were of mild or moderate severity. Changes in visual acuity and biomicroscopy and ophthalmoscopy findings were comparable between groups. There were few nonocular AEs (2/94 [2.1%] vs 3/98 [3.1%]; P = NS), none of them considered treatment related. ConclusionIn these adults and children with bacterial conjunctivitis, treatment with besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days was effective and well tolerated. ClinicalTrials.gov identifier: NCT00972777.

Difluprednate ophthalmic emulsion 0.05% (Durezol&amp;reg;) administered two times daily for managing ocular inflammation and pain following cataract surgery

To evaluate the efficacy and safety of twice-daily difluprednate ophthalmic emulsion 0.05% (Durezol(®)) versus placebo administered before surgery for managing inflammation and pain following cataract extraction. Eligible subjects (N = 121) were randomized 2:1 to topical treatment with 1 drop difluprednate or placebo administered twice daily for 16 days, followed by a 14-day tapering period. Dosing was initiated 24 hours before unilateral ocular surgery. Clinical signs of inflammation (anterior chamber [AC] cell and flare grade, bulbar conjunctival injection, ciliary injection, corneal edema, and chemosis), ocular pain/discomfort, intraocular pressure (IOP), and adverse events were assessed. Clearing of inflammation on day 14 (primary endpoint), defined as an AC cell grade of 0 (≤5 cells) and a flare grade of 0 (complete absence), was achieved in a significantly greater percentage of subjects treated with difluprednate, compared with placebo (74.7% vs 42.5%; P = 0.0006). A significantly greater percentage of difluprednate-treated subjects were free of ocular pain/discomfort on day 14 than placebo-treated subjects (64.6% vs 30.0%; P = 0.0004). Three subjects (3.7%) in the difluprednate group had a clinically significant IOP rise (defined as ≥21 mmHg and a change from baseline ≥10 mmHg at same visit). Difluprednate, administered 2 times daily starting 24 hours before cataract surgery, was highly effective for managing ocular inflammation and relieving pain and discomfort postoperatively. Difluprednate was well tolerated and provides a convenient twice-daily option for managing postoperative ocular inflammation.

Évaluation de l’efficacité d’un collyre azithromycine 1,5 % versus tobramycine 0,3 % sur les signes cliniques de la conjonctivite bactérienne purulente

Introduction Bacterial conjunctivitis is characterized by hyperemia and discharge of one or both eyes. These clinical signs appear quickly and are contagious. This study compares the clinical efficacy (signs and symptoms) and safety of azithromycin 1.5 % eye drops with tobramycin 0.3 %. Patients and methods This was a multicenter, randomized, investigator-masked study including 1,043 patients with purulent bacterial conjunctivitis. Patients received either azithromycin twice daily for 3 days or tobramycin, 1 drop every 2 hours for 2 days, then four times daily for 5 days. The primary variable was clinical cure at the test-of-cure (TOC) visit (D9) on the worst eye. The cure was defined as bulbar conjunctival injection and discharge scores of 0. Clinical signs were evaluated at D0, D3, and D9. Results In the azithromycin group 87.8 % of patients and in the tobramycin group 89.4 % were clinically cured at D9. Clinical cure with azithromycin was not inferior to tobramycin at D9: discharge was absent in 96.3 % of patients treated with azithromycin and 95.1 % with tobramycin. Azithromycin was well tolerated. Conclusions Azithromycin 1.5 % for 3 days (six drops) was as effective as tobramycin for 7 days (36 drops). Furthermore, patients on azithromycin presented earlier clinical cure on Day 3 than patients on tobramycin. Azyter ®, with its convenient dosing (bid for 3 days), is a step forward in the management of purulent bacterial conjunctivitis.