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Efficacy and safety of 1% and 2% rebamipide clear solution in dry eye disease: a multicenter randomized trial
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- Authors
- Issue Date
- 2023-08-03
- Citation
- BMC Ophthalmology, Vol.23(1):343
- Keywords
- Dry Eye Disease ; Quinolones ; Cornea ; Tears ; Intraocular pressure
- Abstract
- 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.
- ISSN
- 1471-2415
- Language
- English
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