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
Price :
$35
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At a glance
- Drugs Brimonidine (Primary)
- Indications Graft-versus-host disease
- Focus Registrational; Therapeutic Use
- Sponsors Ocugen
- 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