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

Eom, Youngsub; Yoon, Kyung Chul; Kim, Hong Kyun; Song, Jong Suk; Hyon, Joon Young; Kim, Hyo Myung

doi:10.1089/jop.2022.0119

Cited by 3 publications

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“…Thus, patients who presented with symptoms suggestive of dry eye syndrome for ≥ 6 months and with increased ocular surface staining and decreased Schirmer 1 test were enrolled. However, TBUT was not included in the inclusion criteria as most dry eye patients had short TBUT in South Korea and Japan in previous studies [ 31 – 34 ]. Although there was no inclusion criterion related to TBUT, the mean TBUT of the three groups in this study were 3.69 ± 1.78, 3.68 ± 1.84, and 3.67 ± 2.96 s.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of 1% and 2% rebamipide clear solution in dry eye disease: a multicenter randomized trial

Eom

Chung

et al. 2023

BMC Ophthalmol

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Background To evaluate the efficacy of 1% and 2% rebamipide clear solution in the treatment of dry eye disease (DED). Methods Two hundred twenty patients with DED were randomly assigned to one of three groups: the 1% rebamipide, 2% rebamipide, or placebo (eye drops containing the same ingredients, except for the active components). Each eye drop was instilled four times daily for 12 weeks. Changes in tear film break-up time (TBUT), corneal and conjunctival staining score, Schirmer 1 test, and the Ocular Surface Disease Index (OSDI) from baseline to 12-week visit between the study groups were compared for efficacy assessment. Results The mean age of study patients was 43.8±14.2 years. The 1% and 2% rebamipide groups showed greater improvement in TBUT (1.99±1.87 and 2.02±2.21 s) at 12 weeks from baseline than the placebo group (1.25±2.93 s). The 2% rebamipide group showed greater improvement in the corneal staining score (− 3.15±2.00) at 12 weeks from baseline than the placebo group (− 2.85±1.80). The 1% and 2% rebamipide groups showed improvement in Schirmer 1 test (1.27±3.86 and 1.50±4.14 mm) at 12 weeks of treatment, but not the placebo group (0.55±2.99 mm). Both the rebamipide groups and the placebo group showed significantly improved OSDI after treatment for 12 weeks; however, there was no significant difference among the three groups. Conclusions 1% and 2% rebamipide clear solutions are an effective therapeutic option for improving TBUT and tear volume, and stabilizing the corneal staining score in DED.

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Section: Discussionmentioning

confidence: 99%

Efficacy and safety of 1% and 2% rebamipide clear solution in dry eye disease: a multicenter randomized trial

Eom

Chung

et al. 2023

BMC Ophthalmol

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“…Primary outcome measures were the change in mean OSDI score at 6 and 12 weeks from baseline and mean National Eye Institute Visual Functioning Questionnaire 25 (NEI-VFQ-25) [32][33][34] score at 12 weeks from baseline. Secondary outcome measures were the changes in mean tear matrix metalloproteinase 9 (MMP-9) immunoassay grade 35 and ω-3 index (ω-6/ω-3 ratio and AA/EPA ratio) at 12 weeks from baseline, mean NEI corneal and conjunctival staining scores, [36][37][38] TBUT, eyelid wiper epitheliopathy grade, 39 MG expressibility and secretion score 40,41 at 6 and 12 weeks from baseline, mean upper and lower MG dropout grades 42 and lipid layer thickness at 12 weeks from baseline. The mean daily frequency of hyaluronic acid eye drop use and compliance with the investigational dietary supplement were also compared as the secondary outcome measures.…”

Section: Assessmentsmentioning

confidence: 99%

Re-Esterified Triglyceride ω-3 Fatty Acids in Dry Eye Disease With Meibomian Gland Dysfunction

Eom,

Jun,

Jeon

et al. 2024

JAMA Ophthalmol

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ImportanceTaking ω-3 supplements has been associated with a reduction in symptoms of dry eye disease (DED) associated with meibomian gland dysfunction (MGD). However, a recent relatively large clinical trial concluded that treating DED with ω-3 consumption was ineffective, potentially warranting additional investigations.ObjectivesTo investigate the effect of re-esterified triglyceride (rTG) ω-3 fatty acid supplementation on DED associated with MGD.Design, Setting, and ParticipantsThis double-masked, parallel-group, randomized clinical trial was conducted at 7 institutions from September 2020 to January 2023. Patients with DED associated with MGD were included and randomly assigned to the ω-3 group (received 1680 mg of eicosapentaenoic acid and 560 mg of docosahexaenoic acid), whereas those in the grape-seed group received 3000 mg of grape-seed oil daily.InterventionsrTG ω-3 Fatty acid supplementation vs grape-seed oil.Main Outcome MeasuresThe primary end point was the Ocular Surface Disease Index (OSDI) from baseline to 6 and 12 weeks. The safety parameters were visual acuity and intraocular pressure change.ResultsA total of 132 patients (mean [SD] age, 50.6 [13.8] years; 103 female [78.0%]) were included in this study. The mean (SD) baseline OSDI scores of the ω-3 and grape-seed groups were 43.5 (16.5) and 44.1 (16.6), respectively. A total of 58 patients (87.9%) and 57 patients (86.4%) in the ω-3 and grape-seed groups, respectively, completed 12 weeks of follow-up. There were no differences in compliance with the dietary supplement intake between groups (ω-3, 95.8% and grape-seed, 95.4%). The OSDI (SD) change from baseline to 6 and 12 weeks was −20.5 (16.0) and −22.7 (15.7), respectively, in the ω-3 group and −15.1 (20.2) and −18.8 (21.7), respectively, in the grape-seed control group (difference at 6 weeks = −5.4; 95% CI, −12.15 to 1.33; P = .12 and at 12 weeks = −3.9; 95% CI, −10.90 to 3.13; P = .28). There were no changes in safety parameters or adverse events related to taking the dietary supplement in either group.Conclusions and RelevanceThis randomized clinical trial did not show a benefit of the rTG form of ω-3 for ameliorating symptoms of DED associated with MGD, although fewer than 60 participants were evaluated in each group. Any secondary outcomes from this study should be considered for hypothesis generation of future evaluations of the effect of the rTG form of ω-3 on DED associated with MGD.Trial RegistrationCRIS Identifier: KCT0004927

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Comparative Efficacy and Safety of Pharmacological Treatments for Dry Eye Disease: A Systematic Review and Network Meta-Analysis

Chen,

Yao,

et al. 2024

Preprint

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

Cited by 3 publications

References 35 publications

Efficacy and safety of 1% and 2% rebamipide clear solution in dry eye disease: a multicenter randomized trial

Efficacy and safety of 1% and 2% rebamipide clear solution in dry eye disease: a multicenter randomized trial

Re-Esterified Triglyceride ω-3 Fatty Acids in Dry Eye Disease With Meibomian Gland Dysfunction

Comparative Efficacy and Safety of Pharmacological Treatments for Dry Eye Disease: A Systematic Review and Network Meta-Analysis

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