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

StatusCompleted
PhasePhase 3
Started

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Record History

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  1. Enrollment target: estimated 740 to confirmed 755v5 Show 6 more changesShow less
    • Primary completion date: Feb 1, 2007
    • Study completion date: Feb 2007 to Feb 1, 2007
    • Start date: May 2004 to May 1, 2004
    • Interventions: Rebamipide (Drug) to Placebo (Drug), Rebamipide 1% (Drug), Rebamipide 2% (Drug)
    • Site details revised at 1 of 63 sites
    • Study title expanded, about 8 words
  2. Trial status: Active, Not Recruiting to Completed
    • Study completion date: Jan 2007 to Feb 2007
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study arms: 0 to 3
    v4
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 63 of 63 sites
    v3
  4. Study sites: 1 to 63v2
  5. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT00201981
Lead Sponsor Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators: Novartis
Conditions
(from sponsor)		 Keratoconjunctivitis Sicca
Related terms Dry Eye Syndromes, Keratoconjunctivitis Sicca
Enrollment 755 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov