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

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

NCT00201981

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

755

Starts

2004-05-01

Expected to finish

2007-02-01

Last updated by the study team

2026-06-15

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

• Sun Valley Arthritis Center, Ltd. — Glendale, Arizona, United States
• Pivotel Research Center — Peoria, Arizona, United States
• Hope research Institute — Phoenix, Arizona, United States
• Buena Vista Eye Care Center — Phoenix, Arizona, United States
• Radiant Research — Scottsdale, Arizona, United States
• Sall Eye Research Center — Artesia, California, United States
• Radiant Research - Irvine — Irvine, California, United States
• Scripps Clinic Medical Group, Inc. — La Jolla, California, United States
• American Eye Institute — Los Angeles, California, United States
• Eye Clinic of San Diego — San Diego, California, United States
• Healthcare Partners Medical Group — Torrance, California, United States
• Centennial Eye Associates — Centennial, Colorado, United States
• Corneal Consultants of Colorado — Littleton, Colorado, United States
• Western States Clinical Research, Inc. — Wheat Ridge, Colorado, United States
• Peter C. Donshik, MDPC — Bloomfield, Connecticut, United States
• Opticare Eye Health Center — Waterbury, Connecticut, United States
• The Eye Associates — Bradenton, Florida, United States
• Hernando Eye Institute — Brooksville, Florida, United States
• Radiant Research, Inc. - Lake Worth — Lake Worth, Florida, United States
• Suncoast Clinical Research, Inc. — New Port Richey, Florida, United States
• Eye Associates International — Ormond Beach, Florida, United States
• Pinellas Eye Center — Pinellas Park, Florida, United States
• Ft. Lauderdale Eye Institute — Sunrise, Florida, United States
• Marvin E. Greenberg, MD PA 7 — Tamarac, Florida, United States
• Alabama Research Center, LLC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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