At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label (Stage 1) and Randomized (Stage 2), 24 Month Study of Safety and Efficacy of Bimatoprost Drug Delivery System in Patients With Open-Angle Glaucoma or Ocular Hypertension
In Brief
A Phase 2 clinical trial evaluating bimatoprost 20 µg generation 2, bimatoprost 15 µg generation 2, and 5 other interventions for Open-Angle Glaucoma and Ocular Hypertension. Completed, enrolled 109 participants across 57 sites in 10 countries.
Detailed Summary
This study will evaluate the safety and efficacy of new ophthalmic formulations of bimatoprost in patients with open angle glaucoma and ocular hypertension. At least 3 dose strengths will be evaluated based on internal data review of each cohort. The study was planned to be conducted in 2 stages. Stage 1 was an open-label and Stage 2 was planned to be masked; however only Stage 1 was conducted.
Study Details
Timeline
Interventions
Single dose of bimatoprost ophthalmic administered in the study eye on Day 1.
Single dose of bimatoprost ophthalmic administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1.
Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1.
One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.