NCT01057147

Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Subjects With Dry Eye - Effects on Central Cornea

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Kubota Vision Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Keratoconjunctivitis Sicca
• Dry Eye

Interventions

Type	Name	Description
DRUG	rebamipide 2% ophthalmic suspension	Instill one drop in each eye four times daily for 12 weeks.
DRUG	placebo eye drops	Instill one drop in each eye four times daily for 12 weeks.

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-01-01
• Completion: 2011-02-01
• First posted: 2010-01-27
• Last updated: 2012-01-11

Locations

19 sites across 1 country: United States