A 1-Year Study in Multiple Clinics Testing Rebamipide Eye Drops for Dry Eye Compared With a Placebo

Rebamipide Ophthalmic Suspension in the Treatment of Dry Eye: A Multicenter, Phase 3, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, 52 Week Study

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00201981

Enrollment

755

Registered

2005-09-20

Start date

2004-05-01

Completion date

2007-02-01

Last updated

2026-06-15

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

Conditions

Keratoconjunctivitis Sicca

Keywords

dry eye, keratoconjunctivitis sicca

Brief summary

The purpose of this study is to determine the potential safety and effectiveness of rebamipide eye drops, an investigational eye drop being developed for the treatment of keratoconjunctivitis sicca (dry eye).

Detailed description

There is a need for effective therapy for dry eye that treats the underlying cause of the syndrome. The goal of this study is to assess the impact of rebamipide on dry eye symptom.

Interventions

DRUGRebamipide 1%

ophthalmic suspension

DRUGRebamipide 2%

ophthalmic suspension

DRUGPlacebo

Rebamipide-matching placebo ophthalmic suspension

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* must have symptoms of dry eye for a minimum of 6 months * must be able to sign and date an informed consent

Exclusion criteria

* presence of anterior segment disease * glaucoma or ocular hypertension * using Restasis * use of topically instilled ocular medications during study * use of contact lenses * history of ocular surgery within 12 months * females who are pregnant, breast feeding, or child-bearing potential and not willing to remain abstinent or use contraception * presence of Stevens-Johnson syndrome * any anticipated change in medication through-out study * concurrent involvement in another study or previous receipt of this drug * cannot be safely be weaned off of ocular medications

Design outcomes

Primary

Measure	Time frame
fluorescein corneal staining (FCS) total score at week 12 and the average primary ocular discomfort (POD) severity score at week 12	12 week and 26 week

Secondary

Measure	Time frame
fluorescein corneal staining (FCS) total score at week 26 and the average primary ocular discomfort (POD) severity score at week 26	12 week and 26 week

Countries

United States

Contacts

STUDY_CHAIRGary Foulks, MD

University of Louisville

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026