Efficacy and safety of 1% and 2% rebamipide clear solution in dry eye disease: a multicenter randomized trial.
BMC Ophthalmol
; 23(1): 343, 2023 Aug 03.
Article
em En
| MEDLINE
| ID: mdl-37537533
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.Palavras-chave
Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Síndromes do Olho Seco
/
Quinolonas
Tipo de estudo:
Clinical_trials
Limite:
Adult
/
Humans
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Middle aged
Idioma:
En
Revista:
BMC Ophthalmol
Assunto da revista:
OFTALMOLOGIA
Ano de publicação:
2023
Tipo de documento:
Article