CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 755 enrolled / 755 target
Drug / intervention
Rebamipide 1% +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00201981
NCT00201981Phase 3CompletedMonitor (2.8/mo)Completion was 232mo ago
CompareCT.gov

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

Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Sep 20, 2005·Updated Jun 15, 2026

In Brief

A Phase 3 clinical trial evaluating Rebamipide 1%, Rebamipide 2%, and 1 other intervention for Keratoconjunctivitis Sicca. Completed, enrolled 755 participants across 63 sites.

Signals

Enrolling slower than its timeline implies

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKeratoconjunctivitis Sicca
CountriesUnited States
CollaboratorsNovartis

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2005
Enrollment StartMay 1, 2004
Primary CompletionFeb 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 20.8 years ago

Arms & Interventions

Rebamipide 1%active_comparator

Participants will receive rebamipide 1% ophthalmic suspension four times daily (QID) for 52 weeks

Drug: Rebamipide 1%
Rebamipide 2%active_comparator

Participants will receive rebamipide 2% ophthalmic suspension four times daily (QID) for 52 weeks

Drug: Rebamipide 2%
Placeboplacebo_comparator

Participants will receive a rebamipide-matching placebo ophthalmically four times daily (QID) for 52 weeks.

Drug: Placebo

Interventions

Rebamipide 1%drug

ophthalmic suspension

Rebamipide 2%drug

ophthalmic suspension

Placebodrug

Rebamipide-matching placebo ophthalmic suspension