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)

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.

Inclusion Criteria:

• Age 18 years and older
• Diagnosis of dry eye as defined by the protocol
• Central corneal staining

Exclusion Criteria:

• Ongoing ocular disease that may interfere with study parameters
• Inability to stop using topical ophthalmic medications throughout the duration of the study
• Inability to stop the use of contact lenses for the duration of the study