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A Phase 3 Randomized, Placebo-Controlled, Double-Masked, Multicenter, Safety and Efficacy Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease

Trial Profile

A Phase 3 Randomized, Placebo-Controlled, Double-Masked, Multicenter, Safety and Efficacy Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 08 Jul 2022

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At a glance

  • Drugs Brimonidine (Primary)
  • Indications Graft-versus-host disease
  • Focus Registrational; Therapeutic Use
  • Sponsors Ocugen
  • Most Recent Events

    • 01 Jun 2020 According to an Ocugen media release, the company announced the decision to discontinue this trial. The decision to stop the trial is based on results of a pre-planned interim sample size analysis conducted by an independent Data Monitoring Committee, which indicated the trial was unlikely to meet its co-primary endpoints upon completion. The study was not stopped based on safety concerns.
    • 01 Jun 2020 Status changed from recruiting to discontinued according the Ocugen media release.
    • 27 Mar 2020 According to an Ocugen media release, the company has Over 95% planned enrollment completed in this trial, topline results anticipated by end of 2020
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