Conjunctival Staining Scores Research Articles

Efficacy of artificial tears containing trehalose and hyaluronic acid for dry eye disease in women aged 42–54 versus ≥ 55 years

Background and objectivesDry eye disease (DED) is common in postmenopausal women. This study evaluated efficacy of a 3-month daily treatment with artificial tears containing trehalose and hyaluronic acid (HA) in women aged 42–54 years (mixed-hormonal status) versus ≥ 55 years (postmenopausal) and with moderate and severe DED. MethodsThis was a post-hoc analysis of three clinical trials assessing the efficacy of artificial tears containing trehalose (3%) and HA (0.15%) in women with an Ocular Surface Disease Index (OSDI) ≥ 18. Patients instilled one drop of the artificial tears in each eye 3 to 6 times daily and were evaluated at baseline and after 84 ± 7 days for DED symptom severity (OSDI), hyperemia (McMonnies scale), tear break-up time (TBUT), corneal and conjunctival staining (Oxford and Van Bjisterveld scales), tear production (Schirmer I test), and ocular symptoms. ResultsA total of 273 women were evaluated, 61 of age 42–54 years; 212 of ≥ 55 years. DED symptoms, as measured by the OSDI, decreased significantly with the treatment in both age groups (p < 0.0001). Conjunctival hyperemia decreased significantly and TBUT increased significantly in both groups, especially in women of age 42–54 (both p < 0.0001). The global (corneal and conjunctival) staining score decreased significantly in both groups, but also more in women of age 42–54 years. No differences were observed between age groups for any of the variables measured, except for visual acuity. DED symptoms were consistently reported more frequently by the mixed hormonal status women, but also the effect of the treatment was more pronounced in this group. ConclusionsArtificial tears with trehalose and HA significantly improved the symptoms of DED in women aged 42–54 and ≥ 55 years. The decrease in symptoms was more pronounced in women of age 42–54 years, suggesting better mechanisms of recovery from inflammation and loss of ocular surface homeostasis.

Comparisons of efficacy and safety between preserved and preservative-free brimonidine tartrate in glaucoma and ocular hypertension: a parallel-grouped, randomized trial

This multicenter (four institutions), randomized, investigator-masked, parallel-group clinical trial evaluated and compared the efficacy and safety of preservative-free and preserved brimonidine tartrate 0.15% in open-angle glaucoma and ocular hypertension. Sixty eyes of 60 patients with intraocular pressure (IOP) ≥ 15 mmHg diagnosed with open-angle glaucoma or ocular hypertension were randomized to preserved (n = 31) and preservative-free (n = 29) brimonidine groups. The enrolled eyes received brimonidine monotherapy three times daily. Main outcome measures were corneal/conjunctival staining score, ocular surface disease index, patient satisfaction score, drug tolerance, and drug adherence rate 12 weeks post first administration. Secondary outcome measurements included visual acuity, IOP, drug tolerance, tear-film break-up time, hemodynamic changes including blood pressure and heart rates, and ocular adverse events. After 12 weeks, both preserved and preservative-free groups showed similar IOP reduction, corneal and conjunctival staining scores, drug tolerance, and adherence rates. The preservative-free group showed significantly better tear-film break-up time and higher patient satisfaction regarding drug use and management. Systolic and diastolic blood pressure reductions during the 12 weeks were significantly lower in the preserved group than in the preservative-free group. Preservative-free brimonidine tartrate showed comparable efficacy and safety, better corneal tear film stability, and patient satisfaction than preserved brimonidine.

Dry eye disease and risk factors for corneal complications in chronic ocular graft-versus-host disease.

The current study was carried out to evaluate the clinical features and management outcomes of dry eye disease (DED) in chronic ocular GvHD following allogenic hematopoietic stem cell transplantation (HSCT). A retrospective review of consecutive patients diagnosed with chronic ocular GvHD between 2011 and 2020 was performed at a tertiary eye care network. Multi-variate regression analysis was carried out for identifying risk factors associated with progressive disease. A total of 34 patients (68 eyes) with a median age of 33 years [inter-quartile range (IQR) 23-40.5] were studied. The most common indication for HSCT was acute lymphocytic leukemia (26%). Ocular GvHD developed at a median of 2 years (IQR 1-5.5 years) after HSCT. Aqueous tear deficiency was present in 71% of the eyes, of which 84% had a Schirmer value of <5 mm. The median visual acuity at presentation and that after a median follow-up of 6.9 months were comparable at 0.1 log minimum angle of resolution (logMAR) (P = 0.97). Topical immunosuppression was required in 88% of cases, and with this, improvement in corneal (53%, P = 0.003) and conjunctival staining scores (45%, P = 0.43) was noted. A progressive disease was present in 32% with persistent epithelial defects being the most common complication. Grade 2 conjunctival hyperemia [odds ratio (OR): 2.6; P = 0.01] and Schirmer's value <5 mm (OR: 2.7; P = 0.03) were found to be associated with progressive disease. Aqueous deficient DED is the most common ocular manifestation of chronic ocular GvHD, and the risk of the disease progression is greater in eyes with conjunctival hyperemia and severe aqueous deficiency. Awareness among ophthalmologists of this entity is essential for its timely detection and optimal management.

Efficacy and safety of 0.05% micellar nano-particulate (MNP) cyclosporine ophthalmic emulsion in the treatment of moderate-to-severe keratoconjunctivitis sicca: a 12-week, multicenter, randomized, active-controlled trial

BackgroundKeratoconjunctivitis sicca or dry eye disease (DED) is a multifactorial disorder underpinned by a complex inflammatory cycle. Introduction of topical cyclosporine has been a significant advance in the management of DED. In recent years advancements in formulation technology have led to development of micellar nano-particulate (MNP) cyclosporine formulations that promise better penetration into ocular target tissues and potential for reduced ocular surface irritation.MethodsWe compared two dosing regimes of a proprietary MNP cyclosporine emulsion with the widely marketed topical cyclosporine formulation Restasis™ in a multicenter parallel-group randomised trial in patients with DED. Patients were randomised to one of 3 treatment groups with 90 patients eligible for the per protocol analysis: 30 in the higher dose test arm A; 32 in the lower dose test arm B; and 28 in the Restasis™ control arm C. All scored efficacy endpoints were tested for significance by comparing the mean change in scores from baseline in the test groups with that in the control group at 12 weeks, using the Student’s t test. Wilcoxon’s rank sum test was used to test individual symptom scores and clinician’s global evaluation of treatment grades.ResultsCorneal fluorescein staining score, the primary efficacy endpoint, decreased by 6.8 ± 4.0, 5.7 ± 3.9, and 4.6 ± 3.6 points in the 3 groups respectively, indicating superior efficacy in test arm A in comparison to control arm C (p = 0.0026). Schirmer’s tear test, conjunctival lissamine staining score, ocular surface disease index, and individual dry eye symptom scores also favoured higher dose MNP cyclosporine over Restasis™. The study failed to differentiate the treatment arms in terms of clinician’s global evaluation of treatment, use of tear substitutes, best corrected visual acuity or safety and toleration.ConclusionThe results indicate that the dose of 1 drop of a 0.05% w/v ophthalmic emulsion of MNP cyclosporine administered topically twice daily yields better outcomes at 12 weeks than the lower dose tested in the study, and is more efficacious than an equivalent dose of Restasis™, the active control used in the study.Trial registrationThis trial was registered in the Clinical Trials Registry of India on 29/03/2019, and was assigned registration number CTRI/2019/03/018319.

Combination Therapy With Diquafosol Sodium and Sodium Hyaluronate in Eyes With Dry Eye Disease After Small Incision Lenticule Extraction.

To evaluate the clinical efficacy of combination therapy with diquafosol sodium and sodium hyaluronate in dry eye patients after small incision lenticule extraction (SMILE). A prospective randomized controlled study was conducted on consecutive patients who were diagnosed with dry eye disease (DED) and ready to accept SMILE from January 2021 to December 2021. The participants were randomly allocated to either a combination with diquafosol sodium 3% and sodium hyaluronate 0.3% group (DQS group, n=40) or a sodium hyaluronate 0.3% group (HA group, n=41). Dry eye disease parameters included tear film break-up time (TBUT), Shirmer I test (SIT), corneal and conjunctival fluorescein staining score (FS score), and Ocular Surface Disease Index (OSDI); tests were conducted before surgery and at 1 week, 1 month, and 3 months after surgery. At 1 week after surgery, there were no statistically significant overall differences in DED parameters between the 2 groups. At postoperative month 1, the FS score was significantly lower in the DQS group than in the HA group (1.20±1.06 vs. 1.83±1.41 respectively, p=0.026). At 3 months after the surgery, the DQS group was significantly superior to the HA group in OSDI (12.98±7.29 vs. 16.82±8.25, p=0.029), TBUT (5.83±2.02 vs. 4.24±0.94, p=0.0002), and SIT (7.75±3.92 vs. 5.24±3.42, p=0.003). Our study showed that combination therapy with diquafosol and hyaluronate was beneficial for improving both signs and symptoms of dry eye patients after small incision lenticule extraction.

Intense pulsed light (IPL) therapy for meibomian gland dysfunction (MGD)-related dry eye disease (DED): a systematic review and meta-analysis.

To compare the effect of intense pulsed light (IPL) therapy and conventional treatments in meibomian gland dysfunction (MGD)-related dry eye disease (DED). A literature search was conducted in PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science, EMBASE, China National Knowledge Infrastructure (CNKI), Wanfang Database, VIP, and China Biology Medicine (CBM) up to January 2022. Randomized controlled trials (RCTs) were included. Mean differences (MDs) and their 95% confidence intervals (CIs) were calculated. A meta-analysis concerning changes in tear break-up time (BUT), changes in Ocular Surface Disease Index (OSDI) scores, changes in non-invasively measured tear break-up time (NIBUT), changes in corneal and conjunctival fluorescein staining (CFS) scores, and changes in Standard Patient Evaluation of Eye Dryness (SPEED) scores was carried out. The initial search identified a total of 1842 records in the databases, and 11 studies were included in the final analysis. Compared to conventional therapies, IPL therapy was associated with significantly reduced OSDI (MD, - 7.49; 95% CI, - 12.47 to - 2.5) and SPEED (MD, - 3.28; 95% CI, - 5.64 to - 0.93) scores, while BUT (MD, 1.94; 95% CI, 1.19 ~ 2.69) and NIBUT (MD, 2.55; 95% CI, 1.07 ~ 4.04) significantly increased. No significant difference was found in the change in CFS between the two groups. Both IPL treatment and traditional treatments are effective in the treatment of MGD-related DED. IPL application seems to be superior to traditional treatments.

Sex-related differences and hormonal effects in the Dry Eye Assessment and Management (DREAM) study

Background/aimsTo compare dry eye disease (DED) signs and symptoms between men and women, as well as between premenopausal and postmenopausal women, in the Dry Eye Assessment and Management (DREAM) study.Methods434...

Effectiveness of Topical Cyclosporin A 0.1%, Diquafosol Tetrasodium 3%, and Their Combination, in Dry Eye Disease.

Purpose: To compare the effectiveness of the topical use of cyclosporin A (CsA) 0.1%, diquafosol (DQS) tetrasodium 3% ophthalmic solution, and their combination in treating dry eye disease in a general health care setting. Methods: This prospective, nonrandomized, observational study analyzed 279 patients. Patients instilled topical CsA 0.1% (Ikervis®; Santen Pharmaceutical Co., Ltd., Japan) once daily and/or DQS tetrasodium 3% (Diquas-S®; Santen) six times a day for 12 weeks. Objective signs [tear break-up time (TBUT), National Eye Institute (NEI) corneal and conjunctival staining scores] and symptoms [Symptom Assessment in Dry Eye (SANDE) and Dry Eye-related Quality-of-Life Score (DEQS) questionnaires] were evaluated at baseline, week 4, and week 12. Results: Patients (n = 279) were mainly female (85.0%) with a mean (SD) age of 50.1 (14.8) years, and received CsA (n = 93), DQS (n = 99), or CsA/DQS (n = 87). Both monotherapies and CsA/DQS combination therapy significantly improved TBUT, NEI corneal and conjunctival staining scores, and SANDE and DEQS scores from baseline to week 12 (all P < 0.0001). The mean change in TBUT between baseline and week 12 was significantly higher in CsA/DQS combination therapy (2.13 ± 2.41 s) than in CsA monotherapy (1.07 ± 1.71 s; P = 0.0011). Conclusions: Monotherapy with CsA or DQS and CsA/DQS combination therapy all significantly improved the objective signs and symptoms of dry eyes during 12 weeks of treatment. CsA/DQS combination therapy provides an additional benefit in terms of TBUT compared with CsA alone; however, a randomized controlled trial still needs to be performed to confirm this result.

Ocular surface assessment of preserved and preservative‐free brimonidine tartrate in glaucoma patients: A parallel‐grouped comparison trial

AbstractPurpose: To evaluate and compare the efficacy and safety of preservative‐free and preserved brimonidine tartrate 0.15% in open‐angle glaucoma and ocular hypertension.Methods: We conducted a multicenter (four institutions), randomized, investigator‐masked, parallel‐group clinical trial. A total of 60 eyes of 60 patients with intraocular pressure (IOP) ≥ 15 mmHg diagnosed with open‐angle glaucoma or ocular hypertension were randomized to preserved (n = 31) and preservative‐free (n = 29) brimonidine groups. Enrolled eyes received three times daily monotherapy of brimonidine. Main outcome measures were corneal/conjunctival staining score, ocular surface disease index, patient satisfaction score, drug tolerance, and drug adherence rate at 12 weeks after the first administration. Secondary outcome measurements included visual acuity, IOP, drug tolerance, tear‐film break‐up time, hemodynamic changes including blood pressure and heart rates, and ocular adverse events.Results: After 12 weeks, both preserved and preservative‐free groups showed similar amount of IOP reduction, corneal and conjunctival staining score, drug tolerance, and adherence rate. The preservative‐free group showed significantly better TBUT and higher patient satisfaction with regard to drug use and management. The reduction amount of systolic and diastolic blood pressures during 12 weeks were significantly lower in the preserved group than the preservative‐free group.Conclusions: Preservative‐free brimonidine tartrate showed comparable efficacy and safety with better corneal tear film stability and patient satisfaction compared to preserved brimonidine.

Effect of OTX-101 in Patients with Dry Eye Disease at Day 14 of Treatment: Ocular Surface Endpoint Results from the Phase 2b/3 Clinical Trial.

Dry eye disease (DED) is a multifactorial disorder characterized by loss of tear film homeostasis, which initiates a cycle of ocular surface inflammation and damage. As ocular discomfort symptoms associated with DED can decrease quality of life, affected patients prefer treatments that rapidly improve the underlying disease process. OTX-101 0.09% (CEQUA®) is indicated to increase tear production in patients with DED. The current analysis assessed early efficacy of OTX-101 0.09% in adult patients with bilateral DED by evaluating ocular surface endpoints after 14 days of treatment in the phase 2b/3 trial. In this randomized, double-masked, vehicle-controlled, dose-ranging study, patients received one drop of OTX-101 0.05%, OTX-101 0.09%, or vehicle per eye twice daily for 84 days. Corneal staining, conjunctival staining, tear breakup time (TBUT), and modified Symptom Assessment iN Dry Eye (SANDE) total global symptom score were assessed at baseline and Days 14, 28, 42, 56, and 84/early discontinuation. Overall, 455 patients were randomized (OTX-101 0.05%, n=151; OTX-101 0.09%, n=152; vehicle, n=152); only baseline and Day 14 results for the approved OTX-101 0.09% formulation and vehicle are presented. Least squares (LS) mean (standard error [SE]) change from baseline in conjunctival staining score was -1.3 (0.1) for OTX-101 and -1.0 (0.1) for vehicle. LS mean (SE) change from baseline in corneal staining score was -1.1 (0.17) for OTX-101 and -0.7 (0.17) for vehicle. LS mean (SE) change from baseline in TBUT was 0.52 (0.15) for OTX-101 and 0.36 (0.15) for vehicle. LS mean (SE) change from baseline in modified SANDE total global symptom score was -4.93 (1.54) for OTX-101 and -9.1 (1.54) for vehicle. OTX-101 0.09% demonstrated a numerically greater treatment effect compared with vehicle in conjunctival staining, corneal staining, and TBUT after 14 days.

Ocular surface health affects the quality of life of the elderly

AbstractPurpose: To examine the association of ocular surface health with the quality of life (QoL) in a population‐based cohort of older people.Methods: This cross‐sectional study included 601 subjects born between years 1933–1956 and living in Savitaipale, Finland. Various ocular surface health parameters were evaluated, including Schirmer's I test, non‐invasive tear break‐up time (NIBUT), corneal and conjunctival staining, conjunctival redness, blepharitis, Meibomian gland dysfunction (MGD), and Ocular Surface Disease Index (OSDI). For QoL measurements 15D, Medical Outcomes Study 36‐Item Short Form Health Survey (MOS SF‐36), and Beck's Depression Inventory.(BDI‐II) were used. Multiple linear regression was used to examine the effects of ocular surface health on QoL.Results: OSDI scores affected majority of the MOS SF‐36 scales as well as 15D and BDI‐II scores (p &lt; 0.05). BDI score worsened with increasing corneal and conjunctival staining and MGD scores (p = 0.004, p = 0.001, and p = 0.03, respectively). Physical and emotional health‐associated role limitations increased with increased conjunctival redness (p = 0.007 and p = 0.005, respectively). In addition, emotional well‐being was affected by conjunctival redness, blepharitis, MGD, and NIBUT (p &lt; 0.05).Conclusions: The symptoms experienced by the participants affect various aspects of well‐being according to our results. Of the ocular surface signs, the ocular surface tissue defects appear to play more significant role in worsening of the general health‐related QoL, whereas the aqueous deficiencies alone do not. The health of ocular surface is an important factor of the QoL and merits to be taken account in clinical assessment of people and these symptoms should be treated accordingly.

Non-Invasive Tear Break-Up Detection with the Kowa DR-1α and Its Relationship to Dry Eye Clinical Severity.

The purpose of this study is to compare visual versus software detection of non-invasive tear break-up with the KOWA DR-1α tear interferometer and investigate the relationship between non-invasive tear break-up time (NIBUT) and dry eye clinical severity. Tear interferometry with the KOWA DR-1α, together with a standardized comprehensive ocular surface/tear evaluation, was performed on 348 consecutive eyes. Investigator visually detected or software detected non-invasive tear break-up and NIBUT were measured and compared on a subset of these examinations. The relationship between software-detected NIBUT and categorical dry eye severity based on irritation symptoms and corneal and conjunctival dye staining scores was determined. The sensitivity of visual (frame-by-frame) or software detected non-invasive tear break-up in eyes with tear instability (FBUT < 10) was similar (range 63−69%). NIBUT, measured visually or by software, had a correlation coefficient of 0.87. NIBUT was significantly lower in severity levels 2 and 3 compared to levels 0 + 1, and level 3 was significantly lower than level 2. In conclusion, there is a good correlation between investigator visually detected and software-detected tear break-up and tear break-up time in the KOWA DR-1α interferometric fringe images. Software-detected NIBUT is a clinically relevant measure of dry eye clinical severity.

A Multicenter, Randomized, Double-Blind Evaluation of the Efficacy of TJO-087 Versus 0.05% Cyclosporine A in Moderate to Severe Dry Eye.

Purpose: To compare the efficacy and ocular tolerability of a 0.08% nanoemulsion cyclosporine A (CsA) (TJO-087) once daily versus a conventional 0.05% emulsion CsA twice daily in dry eye disease. Methods: 178 patients with dry eye disease were randomly assigned to one of two groups: the TJO-087 or CsA0.05% group. Changes in the Ocular Surface Disease Index (OSDI), tear film break-up time (TBUT), corneal and conjunctival staining scores, and Schirmer test scores from baseline to the 32-week visit were compared between both groups. To evaluate ocular tolerability of the study formulations, 7 symptoms (stinging/burning, itching, blurred vision, sandiness/grittiness, dryness, light sensitivity, and pain or soreness) were evaluated (the higher the score, the lower the tolerability) at each follow-up visit. Results: A total of 155 eyes of 155 patients were enrolled. The TJO-087 and CsA0.05% groups showed significant improvement in OSDI, TBUT, ocular surface staining, and Schirmer test scores at 32 weeks from baseline. There was no difference in the extent of improvement in all efficacy parameters. There were no differences in the ocular tolerability scores between the 2 groups at all visits, except that the itching score was higher in the TJO-087 group than in the CsA0.05% group at week 8. Conclusions: Using topical 0.08% CsA once daily is an effective therapeutic option for improving the symptoms and signs in dry eye disease, with a tolerability comparable with that of conventional 0.05% CsA. This trial was registered at the US National Library of Medicine ClinicalTrials.gov (http://clinicaltrial.gov) as NCT05245604 (registration date: 19/06/2020).

Racial and Ethnic Disparities in Dry Eye Diagnosis and Care

ABSTRACT Purpose To investigate health disparities in racial and ethnic minorities with dry eye. Methods Medical records were reviewed for demographics, socioeconomic factors, treatments, and objective dry eye parameters. Race/ethnicity was self-reported as delineated by the U.S. Census. The reference group comprised of randomly selected White patients, with number equal to the largest minority group. Results The study included 465 patients (157 Black, 157 White, 85 Asian, and 66 Hispanic). Compared to White (3.2%) patients, larger proportion of minorities used Medicaid or lacked health insurance (Black 8.3%, P = .054; Asian 10.6%, P = .019; Hispanic 18.2%, P < .001). Black and Hispanic patients had lower estimated median household income than Whites (White $98,472, Black $75,554, P < .001; Asian $105,503, P = .088; Hispanic $86,839, P = .030). Prior to presentation, fewer minority patients received prescription treatments or procedures (White 61.8%; Black 30.6%, P < .001; Asian 43.5%, P = .006; Hispanic 43.9%, P = .014). Although at baseline visit minorities had worse mean conjunctival (White, 1.7; Black 2.2, P = .136, Asian 2.4, P = .022; Hispanic 2.6, P = .005) and corneal staining scores (White, 1.6; Black 2.5, P < .001; Asian 2.3, P = .003; Hispanic 2.4, P = .001), no differences were noted at final visit. Conclusion Minorities presented with worse objective dry eye parameters, and less prior dry eye care. Income and health care access may not fully explain the observed undertreatment at presentation. Differential management by eye care providers and patient attitudes warrant further investigation.

Ocular manifestations in moderate-to-severe psoriasis in India: A prospective observational study.

Ocular manifestations in psoriasis are due to direct eye involvement with psoriatic plaques or psoriasis-related, immune-mediated inflammatory processes. The commonly reported pathologies are blepharitis, conjunctivitis, keratitis, dry eyes, and uveitis. Limited data is available on the ocular findings in psoriasis patients in India. In this study, we evaluated various ocular changes associated with moderate-to-severe psoriasis. In this prospective cohort study, treatment-naive psoriasis patients with Psoriasis Area Severity Index (PASI) score of more than 10 were included. The Ocular Surface Disease Index (OSDI) score, Schirmer's score, tear film breakup time (TBUT), corneal and conjunctival staining score, and meibomian gland dysfunction score were noted. All these parameters were re-evaluated at 8 weeks of follow-up after systemic treatment. Sixty-eight patients were enrolled in the study. The most common ocular pathologies observed in this study were tarsal hyperemia and anterior blepharitis in 128 (94.1%) and 64 (47%) eyes, respectively. Mild, moderate, and severe dry eyes were seen in 26 (19.1%), 14 (10.2%), and 34 (25%) eyes, respectively. Thirty-nine (57.3%) patients complained of significant difficulty watching television or digital screen. In 21 patients evaluated on follow-up at 8 weeks, cornea and conjunctiva's ocular surface staining score increased and TBUT decreased significantly. The most common ocular pathologies observed in this study were anterior blepharitis and moderate dry eye, which significantly affected most patients' daily routines. Screening patients with greater severity of psoriasis would help in early management of such problems.

Reduced tear thrombospondin‐1/matrix metalloproteinase‐9 ratio can aid in detecting Sjögren's syndrome etiology in patients with dry eye

Differentiating patients with Sjögren's syndrome (SS)‐associated dry eye from non‐SS dry eye is critical for monitoring and appropriate management of possible sight‐ or life‐threatening extraglandular complications associated with SS. We tested whether reduced tear levels of immunoregulatory thrombospondin (TSP)‐1, which also inhibits matrix metalloproteinase (MMP)‐9, would reflect SS pathogenesis aiding the identification of patients with SS‐dry eye. Total of 61 participants, including healthy controls (n = 20), patients with non‐SS dry eye (n = 20) and SS‐dry eye (n = 21) were enrolled prospectively. Tear TSP‐1 and MMP‐9 levels were measured using a custom magnetic bead‐based multi‐plex assay in a masked manner. Analyte concentrations were assessed further according to ocular surface and tear film parameters. Relative to median tear TSP‐1 (308 ng/ml) and MMP‐9 (1.9 ng/ml) levels in the control group, significantly higher proportion of patients with SS‐dry eye than non‐SS had lower tear TSP‐1 levels (55% vs. 29%, odds ratio [OR] = 3, 95% confidence interval [CI] = 1.64 to 5.35, p < 0.05) and higher tear MMP‐9 levels (65% vs. 24%, OR = 5.8, 95% CI = 4.46 to 19.81, p < 0.05), respectively. The tear TSP‐1/MMP‐9 ratio was significantly reduced in patients with SS‐dry eye compared to non‐SS (B = −2.36, 95% CI = −3.94 to −0.0.79, p < 0.05), regardless of tear MMP‐9 levels. Patients with a lower ratio were 2.3 times more likely to have SS (OR = 0.28, 95% CI = 0.1 to 0.75, p < 0.05). This ratio showed significant inverse correlations with clinical parameters (conjunctival and corneal staining scores). Our results denote that tear TSP‐1/MMP‐9 ratio can be useful in identifying patients with dry eye with underlying SS and used as a screening test.

Effects of systemic anti-androgen drugs on the ocular surface

To investigate the effect of systemic anti-androgen drugs on tear function tests and the ocular surface. Sixty-four male subjects were included in this study. Subjects who were on anti-androgen treatment for prostate cancer (Group A, n: 31) and those who had received only surgical treatment for prostate cancer (Group B, n: 17) were recruited from the department of urology. Age-matched subjects who had never received anti-androgen treatment (Group C, n: 16) constituted the control group. Group A was divided into two subgroups according to the number of anti-androgen drugs used (Group A1: one drug, Group A2: two drugs). All cases underwent a complete ocular examination, including tear film break up time (TBUT), corneal and conjunctival staining, Schirmer 1 test, conjunctival impression cytology, and ocular surface disease index (OSDI) questionnaire. The mean Schirmer's values were 6.87mm, 11.41mm, and 13.03mm in Groups A, B, and C, respectively (P=0.001). TBUT was 5.45±2.01, 9.85±2.52 and 9.81±1.96seconds in Groups A, B, and C, respectively (P=0.001). Schirmer and TBUT were significantly lower, and corneal staining and OSDI questionnaire scores were higher in Group A compared to groups B and C (P<0.01). Conjunctival impression cytology results according to the Nelson grading system revealed no statistically significant difference between the groups (P=0.422). Anti-androgen drugs alter tear function tests, cause increased corneal and conjunctival staining scores and worsen complaints of dry eye in patients with prostate cancer.

Correlations between clinical parameters of dry eye disease and serologic profiles in Sjögren's syndrome.

To investigate the difference in clinical parameters of dry eye disease (DED) according to the presence of serum anti-La antibodies and evaluate the correlations of autoantibody titers with DED parameters in patients with primary Sjögren's syndrome (pSS). Sixty-two patients diagnosed with pSS according to the 2016 ACR-EULAR classification criteria were classified into two groups depending on the presence of anti-La antibodies: group 1 (anti-Ro positive alone, n = 31) and group 2 (both anti-Ro and anti-La positive, n = 31). DED parameters (conjunctival and corneal ocular staining score (OSS), tear film break-up time (TBUT), Schirmer I test, lipid layer thickness (LLT), meiboscore, and ocular surface disease index), serum autoantibodies (anti-Ro, anti-La, rheumatoid factor (RF), and antinuclear antibody) and focus score were assessed. The DED parameters were not significantly different between the two groups (P > 0.05). The anti-Ro titers, RF-positive rate, and the focus score were significantly higher in group 2 than in group 1 (P = 0.001, P = 0.049, P = 0.001, respectively). The anti-Ro titers had a significant positive correlation with conjunctival OSS (r = 0.273, P = 0.033) and the focus score had a positive correlation with LLT and meiboscore (r = - 0.358, P = 0.072; r = 0.379, P = 0.056). In this study, anti-Ro titers significantly correlated with conjunctival staining score, whereas anti-La did not statistically correlated with clinical DED parameters in SS. Meanwhile, anti-Ro titers and focus score were significantly higher in patients positive for both anti-Ro and anti-La, which suggests that examining anti-La with anti-Ro would be helpful in predicting clinical severities of SS patients.

Generic Cyclosporine in the Treatment of Dry Eye Disease

Objectives: To investigate the efficacy and safety of a generic Cyclosporine 0.05% ophthalmic emulsion in chronic dry eye disease. Materails and Methods: Thirty patients with dry eye disease were included in this observational, prospective study. Patients were examined at baseline, at month -1,-3 and 6 of the study. The following were evaluated at each visit: CDVA (corrected distance visual acuity), corneal and conjunctival staining (Oxford) score, TBUT (tear break-up time), Schirmer-2 score, OSDI (Ocular Surface Disease Index) score, patient’s subjective rating scale of ocular discomfort, daily use of concomittant artificial tears, the researcher's assessment of the global treatment response, and IOP (intraocular pressure). In addition, drug-related side effects were evaluated individually in each examination. When initiating dry eye treatment, cyclosporine was combined with topical loteprednol etabonate 0.5%. Results: There was a statistically significant improvement from baseline in corneal and conjunctival staining (decrease in mean Oxford score), TBUT, Schirmer-2 values, OSDI score, patient’s subjective rating score for ocular discomfort, and mean physician’s subjective assessment of global response to treatment at all follow-up visits (p<0.001). The mean daily use of artifical drops decreased statistically at all time points (<0.001). The most commonly reported adverse events were ocular burning (6.7%), followed by stinging (3.3%), conjunctival hyperemia (3.3%), foreign body sensation (3.3%), and visual disturbance (3.3%). Conclusion: Generic cyclosporine 0.05% ophthalmic emulsion with loteprednol etabonate 0.5% on initiation treatment has well-tolerability and improves subjective and objective measures of dry eye disease.

Effect of low-level light therapy in patients with dry eye: a prospective, randomized, observer-masked trial

To evaluate the efficacy of low-level light therapy (LLLT) with near-infrared light-emitting diodes (LED-LLLT) for the treatment of dry eye. 40 patients were randomly assigned with a 1:1 allocation ratio to receive LED-LLLT (LLLT group, n = 20) or placebo treatment (placebo group, n = 20). Patients in the LLLT group received LLLT twice a week for 3 weeks, for a total of 6 treatment sessions. The primary endpoint was the changes in the fluorescein corneal staining (FCS) score. The secondary endpoints were the changes in the ocular surface disease index (OSDI) score, lissamine green conjunctival staining (LGCS) scores, tear film break-up time (TBUT), Schirmer test, and the meibomian gland dysfunction (MGD) index. These were evaluated before treatment and 4 weeks after start of treatment. The mean difference of score change in primary endpoint revealed significant improvement in the LLLT group, compared to the placebo. Among secondary endpoints, LGCS, Schirmer's test, upper meibography scores showed significant improvements, while TBUT, lid debris, lid swelling, lid telangiectasia, meibomian gland secretion and expressibility scores had slight improvement without significant differences. No serious adverse events were observed. The use of LED-LLLT for the treatment of dry eye and MGD appears to be safe and beneficial.