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.

Recruiting Phase 3 Interventional Study
Glaucoma, Open-Angle Ocular Hypertension
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
168 (estimated)
Sponsor
Amneal Pharmaceuticals, LLC · Industry
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About This Trial
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 ophthal…
Trial Locations
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Eligibility Criteria
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. * Subje…
Contacts

Ilesh Changela, MBBS; MD

+91-79-67778300

ilesh@amnealindia.com

CONTACT