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

Kubota Vision

Status and phase: Completed; Phase 2

Conditions: Dry Eye; Keratoconjunctivitis Sicca

Treatments: Drug: rebamipide 2% ophthalmic suspension; Drug: placebo eye drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT01057147

ACU-RED-204

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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116 participants in 2 patient groups, including a placebo group

rebamipide 2% ophthalmic suspension

Experimental group

Treatment:

Drug: rebamipide 2% ophthalmic suspension

placebo eye drops

Placebo Comparator group

Treatment:

Drug: placebo eye drops