At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 169 enrolled
Drug / intervention
Bimatoprost +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Multicenter, Randomized, Subject- and Examiner-masked, Controlled Clinical Trial Designed to Evaluate the Safety and Effectiveness of the Bimatoprost Ocular Insert as Compared to Topical Timolol Solution (0.5%) in Patients With Glaucoma or Ocular Hypertension.
In Brief
A Phase 2 clinical trial evaluating Bimatoprost, Timolol 0.5%, and 2 other interventions for Primary Open-Angle Glaucoma and Ocular Hypertension. Completed, enrolled 169 participants across 10 sites.
Detailed Summary
The objective of this Phase 2 study is to evaluate whether the Bimatoprost Ocular Insert is non-inferior to that of timolol ophthalmic solution (0.5%) at 12 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Open-Angle Glaucoma, Ocular Hypertension
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 2013
Enrollment StartOct 2013
Primary CompletionSep 2014
Study CompletionNov 2014
TodayJul 2026
First PostedAug 5, 2013
Enrollment StartOct 23, 2013
Primary CompletionSep 30, 2014
Study CompletionNov 14, 2014
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 12.9 years ago
Interventions
Bimatoprostdrug
Bimatoprost ocular insert
Timolol 0.5%drug
Timolol 0.5% solution
Placebo Eye Dropsdrug
Placebo topical eye drops
Placebo Ocular Insertdevice
Ocular insert without any active drug