Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Patients With Dry Eye

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 for the Treatment of Keratoconjunctivitis Sicca (Dry Eye)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01027013

Enrollment

220

Registered

2009-12-07

Start date

2009-12-31

Completion date

2010-11-30

Last updated

2012-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndromes, Keratoconjunctivitis Sicca

Brief summary

The purpose of this study is to evaluate the safety and efficacy of rebamipide 2% suspension for the treatment of patients with dry-eye.

Interventions

DRUGrebamipide 2% ophthalmic suspension

Instill one drop in each eye four times daily for 12 weeks.

DRUGplacebo eye drops

Instill one drop in each eye four times daily for 12 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age 18 years and older * Diagnosis of dry eye as defined by the protocol

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.

Design outcomes

Primary

Measure	Time frame
Total fluorescein corneal staining score	4 weeks
Primary ocular discomfort	4 weeks

Secondary

Measure	Time frame
Dry eye symptoms	12 weeks
Ocular staining	12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026