Late Phase 2 Study of OPC-12759 Ophthalmic Suspension

NCT00475319 ↗

Phase 2 Completed 308 enrolled Otsuka Pharmaceutical Co., Ltd.

RandomizedParallel-groupDouble-blindPrevention

Summary

The purpose of this study is to evaluate the dose-response of OPC-12759 suspension in dry eye patients

Timeline

Start: 2007-05
Primary completion: 2008-03
Completion: 2008-06

Outcome

Met primary endpoint

paper Both 1% and 2% rebamipide were significantly more effective than the placebo in terms of the change from baseline to LOCF for FCS, LGCS, and TBUT scores. PMID 23009892 ↗

Publications

Kinoshita S, Awamura S, Oshiden K, Nakamichi N, Suzuki H, Yokoi N; Rebamipide Ophthalmic Suspension Phase II Study Group. Rebamipide (OPC-12759) in the treatment of dry eye: a randomized, double-masked, multicenter, placebo-controlled phase II study. Ophthalmology. 2012 Dec;119(12):2471-8. doi: 10.1016/j.ophtha.2012.06.052. Epub 2012 Sep 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rebamipide	Small molecule	1 %	Topical
Subject	Rebamipide	Small molecule	2 %	Topical