Purchase this article with an account.
Kazuhide Oshiden, Saki Awamura, Shigeru Kinoshita; Phase III Confirmatory Study Of 2% Rebamipide (OPC-12759) Ophthalmic Suspension Compared With 0.1% Sodium Hyaluronate Ophthalmic Solution In Patient With Dry Eye. Invest. Ophthalmol. Vis. Sci. 2011;52(14):3825.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
To confirm the efficacy of 2% rebamipide ophthalmic suspension compared with 0.1% sodium hyaluronate (HA) ophthalmic solution in patients with dry eye.
A multicenter, randomized, active-controlled, parallel group, 4-week study. Patients with signs and symptoms of dry eye (n=188, mean age 56.6 years) were randomized (1:1) to 2% rebamipide or 0.1% HA. Over the course of the 4 weeks, subjects received 2% rebamipide ophthalmic suspension 4 times daily, or 0.1% HA ophthalmic solution 6 times daily. The primary objective endpoints were fluorescein corneal staining (FCS) and lissamine green conjunctival staining (LGCS). Secondary objective endpoints were tear film breakup time (TBUT) and the Schirmer test. Subjective endpoints included dry eye-related ocular symptoms (foreign body sensation, dryness, photophobia, eye pain and blurred vision) and subject’s overall treatment impression. All 188 randomized patients were included in the statistical analysis.
The primary analysis demonstrated the non-inferiority of 2% rebamipide to 0.1% HA in change from baseline (CFB) in FCS score and the superiority of 2% rebamipide to 0.1% HA in CFB in LGCS score at Week 4 (last observation carried forward : LOCF). TBUT and the Schirmer test did not show any statistically significant difference between the 2 groups. For the subjective endpoints at Week 4 (LOCF), CFB in foreign body sensation and eye pain showed statistically significant improvement for 2% rebamipide in comparison with 0.1% HA. Subject’s overall treatment impression was statistically significantly better for 2% rebamipide than for 0.1% HA. No deaths or treatment-related serious adverse events (AEs) occurred in either group. Dysgeusia was the most frequently observed AEs; 9 subjects in the 2% OPC-12759 and none in the 0.1% HA, and all dysgeusia events were judged to be drug-related and were mild in severity and recovered.
2% rebamipide was effective in treating both signs and symptoms of dry eye patients. Both treatments were well tolerate.
Clinical Trial: :
This PDF is available to Subscribers Only