Efficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome

Kubota Vision

Status and phase: Completed; Phase 3

Conditions: Dry Eye Syndrome

Treatments: Drug: Rebamipide 2% ophthalmic suspension; Drug: Placebo (vehicle)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01632137

ACU-RED-301

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of rebamipide ophthalmic suspension in subjects with dry eye syndrome.

Enrollment: 564 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of dry eye-related ocular symptoms for at least 20 months.
• Meet protocol-defined criteria for corneal and conjunctival staining.
• Meet protocol-defined criteria for ocular discomfort.

Exclusion criteria

• Active anterior segment ocular disease other than dry eye syndrome.
• Inability to suspend the use of topical ophthalmic medications throughout the duration of the study.
• Inability to suspend the use of contact lenses for the duration of the study.
• Judged by the investigator to be ineligible for the study because of a past or concurrent systemic disease, or safety concerns.
• Received any other investigational product within 4 months before the screening visit.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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564 participants in 2 patient groups, including a placebo group

Placebo (vehicle)

Placebo Comparator group

Treatment:

Drug: Placebo (vehicle)

Rebamipide 2% ophthalmic suspension

Experimental group

Treatment:

Drug: Rebamipide 2% ophthalmic suspension