A Phase II, Prospective, Randomized, Double-masked, Parallel Group, Multi-center Study Assessing the Safety and Efficacy of 2% Rebamipide (OPC-12759) Compared to Placebo in Clearing of Fluorescein Staining of the Central Cornea in Subjects With Keratoconjunctivitis Sicca (Dry Eye)

NCT01057147 Phase 2 COMPLETED

The purpose of this study is to evaluate the safety and efficacy of 2% rebamipide compared to placebo in clearing of fluorescein staining of the central cornea in subjects with dry eye disease.

Details

Lead sponsor	Kubota Vision Inc.
Phase	Phase 2
Status	COMPLETED
Enrolment	116
Start date	2010-02
Completion	2011-02

Conditions

• Keratoconjunctivitis Sicca
• Dry Eye

Interventions

• rebamipide 2% ophthalmic suspension
• placebo eye drops

Primary outcomes

• Central corneal clearing as measured by fluorescein staining — 12 weeks

Countries

United States