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Study of Rebamipide Eye Drops to Treat Dry Eye

NCT00201955

CompletedPhase 3

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Conditions: Keratoconjunctivitis Sicca

Interventions: Rebamipide 1%, Rebamipide 2%, Placebo

Countries: United States

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (60)

Birmingham, Alabama, United States
Birmingham, Alabama, United States
Flagstaff, Arizona, United States
Little Rock, Arkansas, United States
Inglewood, California, United States
San Francisco, California, United States
San Marino, California, United States
Colorado Springs, Colorado, United States
Danbury, Connecticut, United States
Gainesville, Florida, United States
Inverness, Florida, United States
Largo, Florida, United States
New Port Richey, Florida, United States
North Miami Beach, Florida, United States
Ocala, Florida, United States
West Palm Beach, Florida, United States
Savannah, Georgia, United States
Evansville, Indiana, United States
Wichita, Kansas, United States
Wichita, Kansas, United States
Louisville, Kentucky, United States
Bossier City, Louisiana, United States
New Orleans, Louisiana, United States
New Orleans, Louisiana, United States
North Andover, Massachusetts, United States
Minneapolis, Minnesota, United States
Gulfport, Mississippi, United States
Creve Coeur, Missouri, United States
Piscataway, New Jersey, United States
Princeton, New Jersey, United States
+ 30 more on CT.gov