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

StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Enrollment target: estimated 740 to confirmed 755

    Primary completion date: Feb 1, 2007; Completion date: Feb 2007 to Feb 1, 2007; Start date: May 2004 to May 1, 2004; and 3 more

    Show all 7 changes in this update
    • Minor Enrollment target: estimated 740 to confirmed 755
    • Minor Primary completion date: Feb 1, 2007
    • Minor Completion date: Feb 2007 to Feb 1, 2007
    • Minor Start date: May 2004 to May 1, 2004
    • Minor Interventions: Rebamipide (Drug) to Placebo (Drug), Rebamipide 1% (Drug), Rebamipide 2% (Drug)
    • Minor Site details revised at 1 of 63 sites
    • Minor Study title expanded, about 8 words
      Show what changed
      A 1-Year Study ofin Multiple Clinics Testing Rebamipide Eye Drops to Treatfor Dry Eye Compared With a Placebo

    Study Identification, Study Status, Sponsor/Collaborators, Study Design, Arms and Interventions, Contacts/Locations, Referencesv5

  2. Minor

    Trial status: Active, Not Recruiting to Completed

    Completion date: Jan 2007 to Feb 2007; Secondary endpoints: details revised at 1 of 1 entry; Study arms: 0 to 3

    Study Status, Sponsor/Collaborators, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locations, Referencesv4

  3. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Site details revised at 63 of 63 sites

    Study Status, Contacts/Locationsv3

  4. Minor

    Study sites: 1 to 63

    Study Status, Contacts/Locationsv2

  5. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • 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 Keratoconjunctivitis Sicca
Enrollment 755 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov