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

NCT00201981

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 (63)
  • Birmingham, Alabama, United States
  • Glendale, Arizona, United States
  • Peoria, Arizona, United States
  • Phoenix, Arizona, United States
  • Phoenix, Arizona, United States
  • Scottsdale, Arizona, United States
  • Artesia, California, United States
  • Irvine, California, United States
  • La Jolla, California, United States
  • Los Angeles, California, United States
  • San Diego, California, United States
  • Torrance, California, United States
  • Centennial, Colorado, United States
  • Littleton, Colorado, United States
  • Wheat Ridge, Colorado, United States
  • Bloomfield, Connecticut, United States
  • Waterbury, Connecticut, United States
  • Bradenton, Florida, United States
  • Brooksville, Florida, United States
  • Lake Worth, Florida, United States
  • New Port Richey, Florida, United States
  • Ormond Beach, Florida, United States
  • Pinellas Park, Florida, United States
  • Sunrise, Florida, United States
  • Tamarac, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Lexington, Kentucky, United States
  • Louisville, Kentucky, United States
  • + 33 more on CT.gov