A Randomized, Double-blind, Multiple Dose, Parallel-group, Two-arm, Multicenter, Bioequivalence Study With Clinical Endpoint Comparing Bimatoprost Ophthalmic Solution 0.01% and LUMIGAN® (Bimatoprost Ophthalmic Solution) 0.01% in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes
Amneal Pharmaceuticals, LLC
Summary
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.
Description
Subjects with chronic open-angle glaucoma or ocular hypertension in both the eyes and meeting all the mentioned inclusion criteria and none of the exclusion criteria will be identified. At baseline (Day 0), subjects qualifying Intra Ocular Pressure (IOPs) following wash-out, with difference between the IOP in left and right eyes not being more than 5 mm Hg, will be randomized. Subjects will instill 1 drop of study drug (either T or R) in both eyes every evening at approximately 10:00 pm for 42 days. The study subjects will undergo clinical evaluations throughout the study in order to assess…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subjects willing and able to provide voluntary informed consent and to follow protocol requirements. * Male or females aged ≥18 years. * Subjects having body mass index (BMI) ≥18.50 kg/m2. * Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes. * Subjects requiring treatment of both eyes and able to discontinue the use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period. * Adequate washout period prior to baseline of any ocular hypotensive medications as per the table below (to m…
Interventions
- DrugTest - Bimatoprost 0.01% Ophthalmic Solution
Subjects 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.
- DrugReference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution)
Subjects 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.
Locations (9)
- Eye Research Foundation Inc.Newport Beach, California
- North Bay Eye Associates, Inc.Petaluma, California
- Volusia Eye AssociatesNew Smyrna Beach, Florida
- Clayton Eye Clinical Research, LLCMorrow, Georgia
- Coastal Research Associates, LLCRoswell, Georgia
- Toyos ClinicNashville, Tennessee