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.
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