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OpenTrials
Completed

NCT Number: NCT00201981

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

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).

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Key information

Conditions

Keratoconjunctivitis Sicca Conjunctival Diseases Conjunctivitis Corneal Diseases Dry Eye Syndromes Eye Diseases Keratitis Keratoconjunctivitis Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alabama Research Center, LLC, Birmingham, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rebamipide 1%

Drug

ophthalmic suspension

Rebamipide 2%

Drug

ophthalmic suspension

Placebo

Drug

Rebamipide-matching placebo ophthalmic suspension

Primary outcomes

  1. fluorescein corneal staining (FCS) total score at week 12 and the average primary ocular discomfort (POD) severity score at week 12

    Time frame: 12 week and 26 week

Secondary outcomes

  1. fluorescein corneal staining (FCS) total score at week 26 and the average primary ocular discomfort (POD) severity score at week 26

    Time frame: 12 week and 26 week

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Collaborators

  • Novartis

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Sep 20, 2005
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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