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.
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.
Female who are pregnant, lactating or planning a pregnancy.
Contraindication or known hypersensitivity to Bimatoprost, related class of drugs, or any of the excipients of formulation.
Current or past history of severe hepatic or renal impairment.
Current or history within 2 months prior to baseline of any other significant ocular disease, e.g., corneal edema, uveitis, ocular infection, or ocular trauma in either eye (Note: stable myopia, strabismus, and cataracts as per the Investigator's discretion will be allowed provided that the other inclusion/exclusion criteria are met).
Amneal Pharmaceuticals, LLC
Lead sponsor
CBCC Global Research
Collaborator