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

NCT00201981 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 755

Last updated 2026-06-15

No results posted yet for this study

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).

Conditions

  • Keratoconjunctivitis Sicca

Interventions

DRUG

Rebamipide 1%

ophthalmic suspension

DRUG

Rebamipide 2%

ophthalmic suspension

DRUG

Placebo

Rebamipide-matching placebo ophthalmic suspension

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Principal Investigators

  • Gary Foulks, MD · University of Louisville

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-01
Primary Completion
2007-02-01
Completion
2007-02-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00201981 on ClinicalTrials.gov