Bioequivalence Study With Clinical Endpoint Comparing Bimatoprost Ophthalmic Solution 0.01% and LUMIGAN® in the Treatment of Chronic Open-Angle Glaucoma or Ocular Hypertension in Both Eyes.
Part of paid clinical trials in Newport Beach, California.
- Sponsor
- Amneal Pharmaceuticals, LLC
- Study ID
- NCT05401357
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Glaucoma, Open-Angle
- Ocular Hypertension
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Test - Bimatoprost 0.01% Ophthalmic Solution — DRUGSubjects in one arm will receive one drop of the test drug in both the eyes every evening at approximately 10:00 pm ± 1 hour for 42 days.
- Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution) — DRUGSubjects in the other arm will receive one drop of the reference drug in both the eyes every evening at approximately 10:00 pm for 42 days.
Study Details
This is a randomized, double-blind, two-treatment, single-period, parallel design, multiple dose at multiple clinical trial sites designed to demonstrate bioequivalence with clinical endpoint in subjects with chronic open-angle glaucoma or ocular hypertension in both eyes. Test Product - Bimatoprost ophthalmic solution, 0.01% of Amneal EU, Limited Reference Product - LUMIGAN® (bimatoprost ophthalmic solution) 0.01% of Allergan, Inc.
Key Dates
- Start date
- Jun 29, 2022
- Status verified
- Aug 2022
- Primary completion
- Dec 31, 2022
- Completion
- Dec 31, 2022
Study Design
- Enrollment
- 168 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Bimatoprost 0.01% Ophthalmic SolutionPharmaceutical dosage form contains LUMIGAN® (bimatoprost ophthalmic solution) 0.01% of Allergan, Inc.
- Active Comparator: LUMIGAN® 0.01% Ophthalmic SolutionPharmaceutical dosage form contains LUMIGAN® (bimatoprost ophthalmic solution) 0.01% of Allergan, Inc.
Primary Outcome Measure
Mean difference in the intraocular pressure (IOP) of both eyes between the two treatment groups. [ Time Frame: Day 14 and 42 at 00.00 hours, 04.00 hours, and 08.00 hours. ]
Central Contacts
- Ilesh Changela, MBBS; MD+91-79-67778300
Locations (9)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Eye Research Foundation Inc. | Newport Beach | California | 92663 | David Wirta, MD 949-554-8763 |
| North Bay Eye Associates, Inc. | Petaluma | California | 94954 | Jason Bacharach, MD |
| Volusia Eye Associates | New Smyrna Beach | Florida | 32169 | Hank Routh, MD |
| Clayton Eye Clinical Research, LLC | Morrow | Georgia | 30260 | Jennifer Kim, MD |
| Coastal Research Associates, LLC | Roswell | Georgia | 30076 | Douglas Day, MD |
| Toyos Clinic | Nashville | Tennessee | 37215 | Melissa Toyos, MD |
| Keystone Research | Austin | Texas | 78731 | Robert Marquis, MD |
| Houston Eye Associates, North Loop | Houston | Texas | 77008 | Kevin Jong, MD |
| Cheyenne Eye Clinic & Surgery Center | Cheyenne | Wyoming | 82001 | Anne Miller, MD |
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