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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01057147

Enrollment

116

Registered

2010-01-27

Start date

2010-02-28

Completion date

2011-02-28

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

Keratoconjunctivitis Sicca, Dry Eye

Brief 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.

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 * 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

Design outcomes

Primary

Measure	Time frame
Central corneal clearing as measured by fluorescein staining	12 weeks

Secondary

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

Countries

United States

Outcome results

None listed

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