Study of Rebamipide Eye Drops to Treat Dry Eye

Completed · Phase 3 · Has a placebo group

Conditions studied: Keratoconjunctivitis Sicca

In brief

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).

Key facts

Study ID

NCT00201955

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

762

Starts

2004-05-01

Expected to finish

2006-07-01

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Michael Bernstein, MD — Birmingham, Alabama, United States
• I Care! Eye Care! — Flagstaff, Arizona, United States
• Harvey and Bernice Jones Eye Institute — Little Rock, Arkansas, United States
• United Medical Research Institute — Inglewood, California, United States
• Benchmark Research — San Francisco, California, United States
• Southern California Clinical Research, Inc. — San Marino, California, United States
• Colorado Eye Associates, PC — Colorado Springs, Colorado, United States
• Danbury Eye Physicians and Surgeons, P.C. — Danbury, Connecticut, United States
• Florida Ophthalmic Institute — Gainesville, Florida, United States
• Florida Wellcare Alliance, L.C. — Inverness, Florida, United States
• Shettle Eye Center — Largo, Florida, United States
• Suncoast Clinical Research, Inc. — New Port Richey, Florida, United States
• Tukio Institute for Clinical Research — North Miami Beach, Florida, United States
• Magnolia Research Group, Inc. — Ocala, Florida, United States
• Radiant Research - West Palm Beach — West Palm Beach, Florida, United States
• Vision Incorporated — Savannah, Georgia, United States
• Welborn Clinic — Evansville, Indiana, United States
• Heartland Research Associates, LLC — Wichita, Kansas, United States
• Wichita Clinic, PA — Wichita, Kansas, United States
• Taustine Eye Center — Louisville, Kentucky, United States
• Bossier Optical, Inc. — Bossier City, Louisiana, United States
• Stevenson Medical Surgical Eye Center — New Orleans, Louisiana, United States
• Family Eye Centers — New Orleans, Louisiana, United States
• Ophthalmic Research Associates, Inc. — North Andover, Massachusetts, United States
• Harold Helms, MD — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.