Moderate Dry Eye Research Articles

Staining Patterns in Dry Eye Syndrome: Rose Bengal Versus Lissamine Green

To evaluate and compare corneal staining patterns of lissamine green (LG) versus rose bengal (RB) in patients with dry eye syndrome. Secondary objectives included addressing patient's comfort after instillation and to correlate disease severity with staining patterns. Randomized, comparative, crossover series. Patients with previous diagnosis of mild to moderate dry eye syndrome were divided in 2 groups regarding dye instillation order (group A: RB first; group B: LG first). Both dyes were applied in regular intervals, and a staining score (van Bijsterveld scale) was used to correlate and compare the results. Disease severity was determined by the Ocular Surface Disease Index. Comfort was evaluated by patient's answer in an objective questionnaire. Sixty eyes of 30 consecutive patients (24 females and 6 males) were included. There was no statistical difference between groups regarding disease severity, sex, or age. LG and RB showed good clinical correlation in both groups (group A: r = 0.939, P < 0.001; group B: r = 0.915, P < 0.001). LG was better tolerated than RB (P = 0.003 in both groups). Overall, we found a low statistical correlation between disease severity and staining scores. Both LG and RB showed similar staining patterns. RB was found to provide greater patient discomfort. There was no correlation between disease severity (addressed by the ocular surface disease index questionnaire) and staining patterns (measured by the van Bijsterveld scale).

A Novel Scraping Cytology Score System (SCSS) Grades Inflammation in Dry Eye Patients

Purpose: We propose a conjunctival Scraping Cytology Scoring System (SCSS) as a reliable method to diagnose and score ocular surface inflammation in dry eye. Methods: Twenty normal subjects and 46 patients with dry eye of various severities were included in the study. Clinical signs were scored 1–4; an Ocular Surface Disease Index (OSDI) questionnaire was used to grade subjective symptoms. Concentrations of serum albumin and interleukin-6 (IL-6) in tears were evaluated. Scraped conjunctival cytology samples were processed and examined with light microscopy. The number of inflammatory cells was staged and sub-scores were assigned. SCSS resulted from their sum and ranged from 0–12. Statistical evaluation was performed by applying the unpaired Student's t-test and the Spearman's correlation test (significance p < 0.05). SCSS was also analyzed for sensitivity, specificity, ROC curves, likelihood ratio LR+, positive (PPV) predictive value. Results: SCSS was positively correlated to clinical sign score, OSDI score, exudated serum albumin, and IL-6 in either control (Spearman's correlation test always p < 0.05) and in dry eye patients (respectively, p < 0.0001, p < 0.01, p < 0.05, and p < 0.0001). SCSS ≥ 4 was selected as the cut-off value for moderate dry eye (LR+ 10,9; PPV 22,5), SCSS ≥ 9 was selected as the cut-off value for severe dry eye (LR+ 15,6; PPV 26,2). Conclusions: SCSS can be applied in any trained laboratory. It is correlated with clinical signs and symptoms, and it shows a diagnostic performance to grade inflammation in dry eye, comparable to more expensive cytokine assay.

Concordance between common dry eye diagnostic tests

Aim:Large variations in results of diagnostic tests for mild to moderate dry eye are widely recognised. The purpose of this study was to assess if there was concordance between common...

Evaluation of Topical Cyclosporine for the Treatment of Dry Eye Disease

To evaluate the use of topical cyclosporine, 0.05% (Restasis; Allergan Inc, Irvine, California), for the treatment of mild, moderate, and severe dry eye disease unresponsive to artificial tears therapy. This was a prospective clinical study. One hundred fifty-eight consecutive patients with dry eye disease unresponsive to artificial tears therapy were divided into 3 groups of disease severity: mild, moderate, and severe. Patients were evaluated using the Ocular Surface Disease Index for symptomatic improvement, tear breakup time, fluorescein staining, lissamine green staining, and Schirmer testing. Patients were observed for 3 to 16 months. The main outcome measure was improvement in disease. Forty-six of 62 patients with mild dry eye disease (74.1%), 50 of 69 with moderate disease (72.4%), and 18 of 27 with severe disease (66.7%) showed improvement, with 72.1% improving overall. Topical cyclosporine shows beneficial effects in all categories of dry eye disease. Symptomatic improvement was greatest in the mild group and the best results in improvement of disease signs were in patients with severe dry eye disease.

Carbomer and Sodium Hyaluronate Eyedrops for Moderate Dry Eye Treatment

This randomized, double-masked study compared the effectiveness of two commercially available ocular lubricants containing either 0.3% Carbomer 934 or 0.18% sodium hyaluronate (SH) in treating moderate dry eye. Sixty-five subjects with dry eye were recruited and supplied with eyedrops containing either Carbomer or SH to use for a month. Principle outcome measures were the severity of symptoms of ocular irritation, tear break-up time without (NIBUT) and with (TBUT) fluorescein, and corneal and conjunctival staining with fluorescein and lissamine green, respectively. At the end of the experiment, subjects were also asked, on average, how many times a day they used the treatment and the duration of any post-instillation blur. Both Carbomer and SH reduced the symptom severity and ocular surface staining, but neither had a lasting effect on NIBUT or TBUT. The treatment effects of Carbomer and SH were equivalent for symptoms, NIBUT and TBUT. However, for both corneal and conjunctival staining, SH outperformed Carbomer in improving the integrity of the ocular surface. There was no difference in the average instillation frequency of the two products. Visual disturbance after instillation of either formulation was generally short, but lengthy periods of blur were significantly more common after the use of Carbomer. Both of the eyedrops trialled are suitable for patients with moderate dry eye, but of the two, the SH-containing treatment has marginal benefits in therapeutic efficacy and has less propensity to cause visual disturbance.

Precorneal Residence Time of Artificial Tears Measured in Dry Eye Subjects

The purpose of this investigation was to measure the precorneal residence time of saline and five marketed artificial tears in dry eye subjects using fluorometry. FITC-dextran, 70 kDa molecular weight, was admixed under sterile conditions (0.1% wt/vol) into buffered saline and the marketed artificial tear formulations of varying viscosity. Precorneal residence time (RT) was measured directly in 16 mild to moderate dry eye subjects, classified by sub-type, in a six-way cross-over, masked and randomized study. FITC-dextran tracer decay with a scanning fluorometer was used to estimate the gross RT (i.e., the time in minutes for the signal to return to baseline). All subjects were classified as having non-inflammatory meibomian gland dysfunction except one, who had a mixture of aqueous deficiency and meibomian gland dysfunction. In two separate determinations, the saline RTs were 19.1 +/- 7.4 and 17.6 +/- 8.2 min. The RTs for the formulations varied to some degree by viscosity, with two higher viscosity formulations demonstrating the longest RTs of 36 to 41 min, approximately twice that of saline (p < 0.001 for both 0.4% polyethylene glycol/0.3% propylene glycol, and 1.0% carboxymethylcellulose). An oil emulsion, low viscosity carboxymethylcellulose and moderate viscosity hydroxypropylmethylcellulose-containing formulation were not statistically different from saline (RTs of 18, 22 and 24 min, p values = 0.983, 0.818 and 0.099, respectively). More than two-fold RT differences were found for the higher viscosity, more muco-adhesive formulations compared to saline. However, other formulations provided RTs close to saline, suggesting that RT is influenced by factors other than simple viscosity. Future studies should examine the interplay of spreading characteristics, pseudoplasticity and muco-adhesion relative to RT to determine the individual and cumulative effects on formulation retention.

Triple Classification of Diagnosis of Dry Eyes

©2008 Ethis Communications, Inc. The Ocular Surface ISSN: 1542-0124. Murube J. Triple classification of diagnosis of dry eyes. 2008;6(2):61-69. syntagma is a unit formed by a group of words whose combination comprises a new meaning, not the original meaning, of a word. For instance, in dry wine, dry does not mean lacking moisture, but without sugar. Similarly, in dry eye, dry does not mean without humidity, but rather less-than-normal dampness, and eye does not mean the eye per se, but the ocular surface. Dry eye is a recent syntagma, which, for the last few decades, has been commonly used by doctors, patients, and the general population. Like many other terms, this syntagma has had fluctuating meanings; at present, it is applied to a clinical picture of ocular dryness symptoms (subjective manifestations of dryness perceived by the patient), signs (objective manifestations of ocular dryness), diseases (morbid condition with a specific origin, manifestation, and name that produces eye dryness), and syndromes (morbid conditions with characteristic associations of clinical manifestations that may be due to different causes). In this paper, dry eye refers to the syndrome consisting of “ disorders produced by the relative deficit between the quantity and quality of the tear secretion and the needs of the ocular surface.” Knowledge of dry eye has developed during three historical periods: The Hippocratic period (V century BC XIX century AD), during which only severe dry eye was identified. The Sjogrenic period (end of the XIX centurythe late XX century), when moderate dry eye was recognized. Now, in the XXI century period, mild dry eye has begun to be recognized. The transition between the three periods has not been abrupt, and there have been overlapping, transitional years. Dry eye syndromes are today considered the most frequent syndromes in ophthalmology, and some form of the syndromes will affect 100% of the population at some stage of their lives. The prevalence of dry eye syndromes varies according to sex, race, geography, socio-sanitary levels, age, and severity. Considering the last two variables (severity and age), severe dry eye affects about 0.002% of people under age 30; 0.01% of people between the ages of 30 and 60, and 0.1% over 60 years old. Medium dry eye affects 0.1% of people under 30, 1% between 30 and 60, and 10% over 60 years old. Mild dry eye affects about 1% of people under 30, 20% between 30 and 60, and 100% over 60 years old. Most people with mild dry eye are unaware that their symptoms belong to a dry eye syndrome. The increasing importance of dry eye has in recent years led to the establishment of several excellent classifications of the syndrome1-3 for different diagnostic, clinical, or treatment purposes. To manage dry eye, the clinician must determine the characteristics of the syndrome based on examination and the patient’s description in order to establish a diagnosis, prognosis and treatment. Therefore, many xerodacryologists from all over the world reached a consensus on the Triple Classification of Dry Eye.1 The three parameters for classification of dry eye in individual patients are: 1) etiology/pathogenesis, 2) type of affected glands and tissues, and 3) degree of severity. Identification of these parameters is essential to establish the type of dry eye syndrome and its specific characteristics. This knowledge allows the determination of the prognosis and the appropriate environmental, medical, physical, surgical, and psychological treatment of each patient with dry eye syndrome. The components of each parameter are shown in Table 1.

Time course of ocular surface and lacrimal gland changes in a new scopolamine-induced dry eye model

The aim of this study was to set up an animal model of dry eye showing disturbance in several components of the lacrimal functional unit, and to describe the time course of the appearance of clinical signs and inflammatory markers. Dry eye was induced in 6-week-old female Lewis rats by a systemic and continuous delivery of scopolamine via osmotic pumps implanted subcutaneously. We first determined the appropriate dose of scopolamine (6, 12.5, or 25 mg/day) for 28 days. In a second set of experiments, we determined markers after 1, 2, 3, 7, 10, 17, or 28 days of a 12.5-mg/day dose. Clinical signs of corneal dryness were evaluated in vivo using fluorescein staining. MHC II expression and mucin Muc5AC production were detected on the conjunctival epithelium using immunostaining. The level of IL-1beta, IL-6, TNF-alpha, and IFN-gamma mRNA was evaluated by real-time polymerase chain reaction in conjunctiva and exorbital lacrimal gland (LG). Lipids were extracted from the exorbital LG for fatty acid analysis. Daily scopolamine doses of 12.5 mg and 25 mg applied for a 28-day period induced keratitis, a decrease in Muc5AC immunostaining density in the conjunctival epithelium, and modifications in the fatty acid composition of the exorbital LG. Animals treated with a 12.5-mg/day dose of scopolamine exhibited an increase in corneal fluorescein staining after 2, 10, and 28 days. All animals exhibited unilateral or bilateral keratitis after 17 days. In the conjunctival epithelium, a significant decrease in Muc5AC immunostaining density was observed at early and late time points, and MHC II expression tended to be increased after 1, 7, 10, and 28 days, without reaching statistical significance. The levels of TNF-alpha, IL-1beta and IL-6 mRNA were increased with scopolamine treatment in both conjunctiva and exorbital LG. Arachidonic acid and the Delta5 desaturase index were significantly increased in the exorbital LG of dry eye animals at each time point. This systemic and continuous scopolamine-induced model of dry eye in the rat may represent a helpful tool to investigate moderate dry eye, and makes a contribution in the field of dry eye study.

Correlation between diagnostic tests guides the development and use of a dry eye diagnostic algorithm

Abstract Purpose: The existence of large variations in results of diagnostic tests for cases of mild to moderate dry eye is widely recognised. The purpose of this study was to assess if there was correlation between existing dry eye diagnostic tests and attempt to develop a diagnostic algorithm. Methods: A total of 91 subjects were recruited to the study. The tear film and ocular surface were evaluated by measuring tear volume using the phenol red thread test, tear break up time using fluorescein, biomicroscopic examination of meibomian glands and impression cytological (IC) assessment of conjunctival goblet cells. Dry eye symptoms were assessed using McMonnies dry eye questionnaire and statistical correlations were assessed between all dry eye tests used. Results: In this study cohort there were no severe aqueous deficient dry eye patients. Meibomian gland pathology, questionnaire (score of ≥14), IC and an altered tear break up time (reference ≤7 seconds) demonstrated correlation, while no other tests demonstrated evidence of correlation. A diagnostic algorithm was devised using these tests alone, with maximum weighting placed on questionnaire with decreasing weighting assigned to IC goblet cell grade, meibomian gland pathology and TBUT. Conclusions: We propose this development of a flexible probabilistic algorithm as a rational approach when diagnosing mild/moderate dry eye in large study groups. Until further studies have demonstrated the true sensitivities and specificities of dry eye tests within the context of test sequences and particular patient cohorts are known, comparison of results between dry eye studies will remain questionable.

Non-contact Confocal Microscopy of the Tear Film in Unoperated Eyes

The NIDEK ConfoScan4 (CS4) is a digital scanning slit confocal microscope. The corneal structure and tear film can be viewed, magnified, measured, and photographed at magnifications up to 500x, in vivo, in a noninvasive manner. The objective of this study was to evaluate and illustrate various conditions related to dry eye using the CS4 confocal microscope with the 20x noncontact lens. The CS4 was used to evaluate the natural tear film in 58 eyes of 29 patients with normal examinations, allergic conjunctivitis, nonspecific conjunctivitis, and dry eyes. In a subset of this patient population, subjective and objective findings were used to classify mild, moderate, and severe dry eye disease states. The usefulness of confocal microscopy as an objective tool to diagnose and manage different tear film-related ocular disease was also evaluated. The differences in tear film composition were visible using confocal microscopy. Photographs demonstrate confocal noncontact 20x microscopy as a diagnostic tool. Noncontact confocal microscopy is a valuable tool in the diagnosis and treatment of dry eye syndrome and other ocular states such as allergic and nonspecific conjunctivitis. It provides a simple and effective way to observe, classify, and treat the tear film. As investigators visualize and learn more, understanding of this structure will continue to improve.

Clinical Performance of a Mid-Viscosity Artificial Tear for Dry Eye Treatment

We report the results of 3 studies conducted to evaluate the performance of a 1.0% carboxymethylcellulose (CMC) mid-viscosity artificial tear compared to currently marketed low-viscosity tears. First, a single-center, double-masked, randomized, crossover study was performed to compare the effect on the Ocular Protection Index (OPI) of the mid-viscosity tear compared to low-viscosity tears in 39 subjects with mild to moderate dry eye. Second, a 1-month, 2-arm, parallel, randomized double-masked clinical study assessed objective signs and subjective symptoms of dry eye in 103 subjects with mild to moderate dry eye. Third, in a 1-month home-use test, 465 artificial tear users compared the mid-viscosity tear or a current low-viscosity tear to their current artificial tear. The OPI study showed prolonged tear breakup time and improved OPI for at least 20 minutes after instillation of the mid-viscosity tear. The low-viscosity tears showed improvements for 5 to 10 minutes. The 1-month clinical study showed a significant reduction in staining and dry eye symptoms after 1 week of treatment, with a further reduction in staining after 1 month in the mid-viscosity group. Subjects provided more reports of blur with the mid-viscosity tear than with a low-viscosity tear, but equivalent overall acceptability. The home use test showed general acceptability of the mid-viscosity tear, including more subjects indicating that it was needed less frequently than their prior low-viscosity tear. This 1% CMC mid-viscosity tear showed protection of the ocular surface after instillation and significant reduction in signs and symptoms of dry eye. Improvements were greater than with low-viscosity tears. The mid-viscosity artificial tear was rated well in comfort, duration of benefit, and general acceptability.

Effect of an Oil-in-Water Emulsion on the Tear Physiology of Patients With Mild to Moderate Dry Eye

To determine the effect of an oil-in-water emulsion eye drop compared with a conventional dry eye supplement (hypromellose) on tear physiology in dry eye. A randomized parallel, longitudinal, and investigator-masked study of the efficacy of 1.25% castor oil emulsion and 0.32% hypromellose solution was carried out. A total of 53 patients with mild to moderate dry eye (27 in emulsion group and 26 in hypromellose group) were recruited for the study. Patients were enrolled if they reported at least 2 symptoms on a McMonnies Dry Eye Questionnaire together with 1 of the following screening tests: noninvasive tear breakup time (5-10 seconds) and Schirmer test without anesthesia (2-5 mm in 5 minutes). Patients were instructed to use the test solutions 3 times a day for 30 days. Tear production, evaporation, lipid layer structure, and osmolality were measured before and 30 days after use of the drops. A statistically significant decrease was seen after 1 month in tear evaporation rates with both emulsion (7.25 +/- 5.43 g/m2/h) and hypromellose (2.02 +/- 4.75 g/m2/h). However, the decrease with emulsion was significantly greater than with hypromellose (P < 0.001). Lipid layer structure improved from day 1 to day 30 of the study with the emulsion but not with the hypermellose. No significant changes were seen in tear production and osmolality with either of the drops. The oil-water emulsion was more effective in reducing tear evaporation than hypromellose after repeated application over a 1-month period. This finding signifies the potential of the emulsion in the management of evaporative dry eye.

Amélioration de la symptomatologie chez des patients atteints de sécheresse oculaire et traités oralement par des acides gras polyinsaturés

Polyunsaturated fatty acids (PUFAs) are involved in inflammatory pathways via prostaglandins. Conjunctival inflammation is a hallmark of all dry eye syndromes. We investigated the role of dietary n-6 and n-3 fatty acids in patients suffering from ocular dryness.Seventy-one patients presenting with mild to moderate dry eye syndromes were randomly assigned to Nutrilarm or placebo capsules, twice a day for 6 months. The Schirmer test, BUT, fluorescein staining, and lissamin green stainings were performed at inclusion and after 1, 3, and 6 months. Furthermore, a questionnaire related to the dry eye symptoms and global discomfort was provided at every visit.The Schirmer test, BUT, fluorescein staining, and lissamin green stainings were improved with treatment when compared to placebo but the difference was not statistically significant. The efficacy evaluated by the patients and the investigator were nearly significant (p=0.052 and p=0.054, respectively). For some signs, such as reflex tearing and conjunctival hyperemia, the improvement reached the threshold of significance (p=0.047 and p=0.045, respectively). The same results were found with skin quality and emotional condition, which were improved (61% with treatment versus 36% with placebo).This double-masked pilot study shows that PUFAs seem to be an interesting tool to alleviate the symptoms related to dry eye syndrome. These results should be confirmed using a larger study population.

A clinical study of the efficacy of topical corticosteroids on dry eye

To evaluate the effect of topical corticosteroid for treatment of moderate or severe dry eye. Sixty eyes of 30 patients with moderate or severe dry eye, who were not sensitive to artificial tears, were treated with 0.1% fluorometholone eye drops. Subjective symptom and objective tests were used to evaluate the efficacy of treatment before and after application of 0.1% fluorometholone eye drops for 1 week and 1 month. Side effects were also evaluated. After 1 week of treatment, subjective symptoms were improved in all dry eye patients; objective tests were improved in all dry eye patients 1 month after treatment, and the difference was significant. Topical corticosteroid drops can rapidly and effectively relieve the symptoms and signs of moderate or severe dry eye.

Conjunctival Cytokine Expression in Symptomatic Moderate Dry Eye Subjects

To compare ocular surface cytokine expression in healthy controls and subjects with moderate dry eye and to study the ability of interleukin (IL)-1beta to modulate cytokine expression in cultured human conjunctival epithelial cells (CECs). Subjective (symptom questionnaire) and objective (tear osmolality, fluorescein tear break-up time [TBUT]) measures of dry eye were determined in five healthy controls and five subjects with moderate dry eye. Tear clearance rates were measured with a fluorophotometer. Enzyme immunoassay and a cytokine bead assay were used to quantify IL-1beta in tear fluid. RT-PCR was performed to detect expression of IL-1beta, IL-6, IL-8, growth-related oncogene (GRO)-beta, intercellular adhesion molecule (ICAM)-1, tumor necrosis factor-related apoptosis-inducing ligand (TRAIL), and ephrin A5 in conjunctival impression cytology (CIC) samples and in CECs (IOBA-NHC cell line, n=3; primary cultured CEC, n=3) exposed to 10 ng/mL IL-1beta for 6 hours. Subjects with moderate dry eye had significantly higher symptom scores, higher tear osmolality, and shorter TBUT than healthy controls. Subjects with dry eye demonstrated slightly slower tear clearance (13.1% per minute) than healthy controls (15.4% per minute). Very low levels of IL-1beta protein were detected in the tear fluid of both groups. TRAIL was constitutively expressed in CIC samples, whereas IL-1beta, IL-6, and GRO-beta were absent. Weak expression of IL-8 (two healthy, four dry eye), ICAM-1 (four healthy, four dry eye), and ephrin A5 (one healthy, two dry eye) was observed. IL-1beta upregulated its own expression and that of IL-6, IL-8, GRO-beta, and ICAM-1 in cultured CECs but not that of ephrin A5 or TRAIL. The lack of major differences in ocular surface cytokine expression between the two groups of subjects implies other inflammatory pathways or etiologies are involved in moderate dry eye. Although IL-1beta modulated the expression of various cytokines in cultured CECs, its absence in tear fluid and CIC samples suggests that IL-1beta does not play a modulatory role in moderate dry eye.

Distribution of Conjunctival HLA-DR Expression and the Pathogenesis of Damage in Early Dry Eyes

To examine the expression of HLA-DR, a marker of inflammation, in the early stages of dry eye disease and to locate the appearance of this marker on specific areas of the bulbar conjunctiva. Dry eye patients were identified and their condition classified as mild (n = 16) or moderate (n = 16) based on Schirmer testing, vital staining, tear break-up time, and symptom questionnaire scores. Brush cytology was used to collect epithelial cells from the nasal, temporal, and superior conjunctivae of patients and age-matched controls. HLA-DR positive cells were detected by immunohistochemical staining and quantified. Patients with moderate dry eye had the highest rate of conjunctival HLA-DR-positive cells, with significantly higher rates than controls regardless of which region of the conjunctiva was sampled (P < 0.01). The mild dry eye group had similar rates of HLA-DR-positive cells in the superior conjunctival region compared with controls. However, in the nasal and temporal regions, they displayed a significantly higher rate of HLA-DR-positive cells than controls (P < 0.01) and the nasal region showed a significant difference (P < 0.01) when compared with the temporal one. Some of these mild dry eyes had no vital staining. The HLA-DR expression pattern in mild and moderate dry eyes appears to reflect disease progression. Overexpression of HLA-DR in mild dry eyes showing no vital staining suggests that inflammation may be a primary cause of ocular surface damage. These data support the use of immunomodulatory drugs in the treatment of dry eye disease.

Effect of Artificial Tears on Visual Performance in Subjects With Dry Eye

Disruption of the anterior refracting surface of the eye (i.e., the tear layer) reduces visual performance. Tear layer breakup occurs soon after a blink in contact lens wearers and patients with dry eye. This study determined whether artificial tears stabilize the tear film and improve visual performance in contact lens wearers who also exhibit a dry eye. Five subjects with mild to moderate dry eye (probably as a result of an evaporative dry eye) during spectacle and contact lens wear were fitted with a Focus Night & Day hydrogel lens for this study. A temporal, two-alternative, forced-choice paradigm was used to measure contrast sensitivity. The stimuli were vertically oriented sine wave gratings (between 0.5 and 14 cpd) presented for 16.67 msec. The stimuli were presented at two different times after blink detection: 2 sec after blink detection (i.e., before tear layer breakup) or 4 sec after tear film breakup. Four conditions were investigated at 4 sec after tear layer breakup: 1) without artificial tears added, 2) with Clerz2 (Alcon, Fort Worth, TX) instilled, 3) with Sensitive Eyes (Bausch & Lomb, Rochester, NY), and 4) with GenTeal (Novartis, Basel, Switzerland) applied. The artificial tears were instilled at 10-min intervals during the data collection. The short-term visual effects of drop instillation were also investigated by continually monitoring contrast sensitivity for a 14-cpd grating after a single-drop administration. High spatial frequency contrast sensitivity and visual acuity were found to be reduced after tear film breakup in the absence of supplementation with artificial tears. For the group data (and four of five subjects), the instillation of Sensitive Eyes improved the contrast sensitivity and visual acuity to the level attained before tear breakup, thus prolonging visual performance. Clerz2 and GenTeal did not produce any enhancement in visual performance. A short-term decrease in contrast sensitivity was also observed with a single administration of Clerz2 and GenTeal. This study indicates that there was a benefit of Bausch & Lomb Sensitive Eyes tear supplementation on visual performance in subjects with an evaporative dry eye. This may be the result of 1) aqueous supplementation in these subjects and/or 2) the minimal tear layer disruption found with Sensitive Eyes drop administration. The results suggest that practitioners need to identify those patients who can benefit from the use of appropriate artificial tear supplements.

Effectiveness of sodium hyaluronate eyedrops in the treatment of dry eye

Dry eye is a common condition, affecting approximately 10-20% of the adult population. Artificial tears are often effective in relieving symptoms in mild and moderate dry eye by replenishing deficient tear volume. Sodium hyaluronate has been proposed as a component in artificial tears, due to its viscoelastic rheology. This paper reports on a study carried out to assess the efficacy of two recently developed eyedrops containing 0.1% and 0.3% sodium hyaluronate (SH) in the treatment of moderate dry eye. Thirteen subjects were recruited with moderate dry eye. Forty microlitres of 0.1% SH, 0.3% SH, or 0.9% saline were instilled in both eyes, and the subjects' symptom intensity and non-invasive break-up time (NIBUT) were measured at 5, 15, 30, 45, and 60 min, and then hourly, until 6 h after drop instillation. This was repeated twice following an interval of 7(+/-1) days, but with a different treatment so that at the end of the final visit each subject had trialled all products. Drop allocation was randomized and double-masked. Both symptoms and NIBUT improved with all treatments. These changes were of a larger magnitude and longer duration with the SH containing eyedrops than with saline. SH of 0.3% tended to perform better than 0.1% SH and achieved statistical significance (P=0.04) for NIBUT when considered over the whole 6-h study period. Sodium hyaluronate of 0.1% and 0.3% reduces symptoms of ocular irritation and lengthens NIBUT in subjects with moderate dry eye more effectively than saline, in terms of peak effect and duration of action.

The Diagnosis and Characteristics of Moderate Dry Eye in Non-Contact Lens Wearers

To identify and characterize moderate dry eye in non-contact lens wearers with a new scoring system-based dry eye questionnaire and to determine which objective tests better differentiate patients with moderate dry eye from healthy patients. Fifty-two healthy subjects (21 women and 31 men with a mean age of 27.8 +/- 9.2 years) and 37 subjects with moderate dry eye (33 women and 4 men with a mean age of 36.4 +/- 12.9 years) completed a 42-item dry eye questionnaire. Seventeen healthy subjects (11 women and 6 men with a mean age of 30.5 +/- 9.7 years) and 28 subjects with moderate dry eye (24 women and 4 men with a mean age of 38.50 +/- 3.8 years) underwent additional objective assessment of ocular surface health, tear osmolality, tear stability, and tear volume. Subjects with moderate dry eye scored significantly higher (49.8 +/- 20.3, P<0.0001) on the dry eye questionnaire than did normal subjects (11.7 +/- 10.3). Ocular irritation symptoms worsened with progression of time of day in both groups of subjects. Internal reliability (0.95 Cronbach alpha) was excellent, and concurrent validity (Spearman rho 0.507) was acceptable when compared to the McMonnies and Ho dry eye questionnaire. Significant differences in tear osmolality (P<0.00001), invasive tear breakup time (P<0.034), and corneal vital dye staining (P<0.0001) were detected between the two groups of subjects. A stepwise linear regression on objective clinical tests, however, did not account for 77% of the total variance in the questionnaire scores. A unique scoring system-based dry eye questionnaire was validated to separate non-contact lens wearers with moderate dry eye from healthy subjects. Objective tests of tear osmolality and stability and ocular surface integrity were better than other clinical measures at identifying differences between the two subject groups. The results strongly support the evidence that the diagnosis and treatment of moderate dry eye requires a detailed assessment of self-perceived symptoms and that objective clinical testing alone may be insufficient.

An open-label evaluation of HP‐Guar gellable lubricant eye drops for the improvement of dry eye signs and symptoms in a moderate dry eye adult population

ABSTRACTObjective: Evaluate the efficacy of a polymer hydroxypropyl guar (HP‐Guar) gellable lubricant eye drop (Systane* Lubricant Eye Drops) in reducing dry eye signs and symptoms among dry eye patients who exhibited at least moderate signs and symptoms.Methods: 168 patients with moderate dry eye signs and symptoms were enrolled at 29 sites in this open label study. The mean age of patients was 62 years with a minimum age of 28 years and a maximum of 90 years. One hundred and forty-seven patients completed the study, 111 female and 35 male, excluding 1 subject (gender not captured). In order to be included in the study, subjects were required to have a total corneal staining score ≥ 4 (NEI grid) in at least one eye, with a grade ≥ 2 in at least one zone of the same eye. Patients also had to indicate that their eyes ‘felt dry enough to want to use eye drops’ at least ‘some of the time’ on a standardized frequency scale. Eligible patients were dispensed a run-in drop (Opti-Free Express Rewetting Drops*) to use QID for 7 days, and then examined. Patients continuing to meet the inclusion criteria were dispensed the test drops (HP‐Guar gellable lubricant eye drops) to use QID, and re-examined on Day 28. At each visit, corneal and conjunctival staining were measured, and six ocular discomfort symptoms were rated on a standardized 0–4 severity scale. At Days 0 and 28, patients subjectively rated product acceptability using a Likert scale.Results: No significant changes in corneal or conjunctival staining were observed with the use of the run-in drop. After 28 days of test drop use, there was a statistically significant reduction in corneal staining ( p < 0.0001). Ninety-four percent of patients improved from baseline, with mean reduction in total corneal staining of 4.1 units (0–15 total scale) (62%). Conjunctival staining also improved significantly ( p < 0.0001) with a mean total reduction of 3.1 (59%). Patients experienced statistically significant symptomatic relief from day 0 to day 28 for all six ocular discomfort severity questions ( p < 0.0001).Conclusion: Lubricating drops effectively relieved signs and symptoms associated with moderate dry eye, with measurable improvements evident in both objective staining and subjective questionnaire measures after 28 days in this study population.