Bioequivalence Study for Glaucoma and Ocular Hypertension
This study is testing if two eye drop solutions, Bimatoprost Ophthalmic Solution, 0.01% and LUMIGAN® (bimatoprost ophthalmic solution) 0.01%, work similarly to lower eye pressure in people with chronic open-angle glaucoma or ocular hypertension (high pressure in the eye). You would receive one drop in both eyes every night for about 6 weeks. Researchers will measure your eye pressure at specific times during weeks 2 and 6 to see if the treatments have similar effects. The study also looks at any side effects you might experience. We are looking for about 240 participants aged 18 or older who have glaucoma or ocular hypertension in both eyes and can stop their current eye pressure medications.
- Study design
- This is a randomized, double-blind study, meaning you and your doctors won't know which eye drops you're receiving. It involves two groups and is planned to include 240 participants.
- What's involved
- You would instill one drop of the assigned eye solution in both eyes every night for 42 days (about 6 weeks). Eye pressure measurements will be taken at specific times during visits at week 2 and week 6.
- Compensation
- Not stated in the trial record.
- Follow-up
- Eye pressure measurements are taken at Day 14 (Week 2) and Day 42 (Week 6) visits.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Randomized, Double-blind, Parallel-group, Two-arm, Multiple Dose, Multicenter, Bioequivalence Study With Clinical Endpoint in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes
At a glance
Conditions
Where it's being run
4 sites across 3 statesWho to contact
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What this trial measures
- Primary Endpoint00.00 hour, 04.00 hours (4 hours ±1 hour after 00.00 hour), and 08.00 hours (8 hours ±1 hour after 00.00 hour) at Day 14 (Week 2) (± 4 days) and Day 42 (Week 6) (± 4 days) visits
Mean difference in the IOP of both eyes between the two treatment groups at 3 time points