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NCT05401357 · ClinicalTrials.gov registry record · Phase 3
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.
A Phase 3 study of Ocular Hypertension and Glaucoma Open-Angle, sponsored by Amneal Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 168
- Enrollment target
- 9
- Study locations
NCT05401357 is a Phase 3 study of Ocular Hypertension and Glaucoma Open-Angle that is actively recruiting participants, run by Amneal Pharmaceuticals. The registered enrollment target is 168 participants, below the 275-participant average among 54 other Ocular Hypertension trials with a reported enrollment target (39% lower). The trial reports 9 study locations across 6 states.
The verdict
NCT05401357, a Phase 3 study of Ocular Hypertension and Glaucoma Open-Angle, is actively recruiting participants, sponsored by Amneal Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 168 participants
- Enrollment target
- 9
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Test - Bimatoprost 0.01% Ophthalmic Solution
- DRUG Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution)
Study Locations (9)
California
- Eye Research Foundation Inc. - Newport Beach
- North Bay Eye Associates, Inc. - Petaluma
Georgia
- Clayton Eye Clinical Research, LLC - Morrow
- Coastal Research Associates, LLC - Roswell
Texas
- Keystone Research - Austin
- Houston Eye Associates, North Loop - Houston
Florida
- Volusia Eye Associates - New Smyrna Beach
Tennessee
- Toyos Clinic - Nashville
Wyoming
- Cheyenne Eye Clinic & Surgery Center - Cheyenne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2022-06-29 |
| Est. Completion | 2022-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05401357
The ClinicalTrials.gov registry entry for NCT05401357 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 168 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 275-participant average among 54 other Ocular Hypertension trials with a reported enrollment target (39% lower). The listed sponsor is Amneal Pharmaceuticals, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Ocular Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Test - Bimatoprost 0.01% Ophthalmic Solution is the first listed.
NCT05401357 reports 9 study locations spanning 6 distinct geographic areas - top geographies include California, Georgia, Texas.
Frequently Asked Questions
What is clinical trial NCT05401357 about?
NCT05401357 is a clinical study titled "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.". 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 - Bimatopros...
What is the current status of trial NCT05401357?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 168 participants. The study started on 2022-06-29. Estimated completion is 2022-12.
What conditions does trial NCT05401357 study?
This clinical trial studies the following conditions: Ocular Hypertension, Glaucoma Open-Angle.
What interventions are being tested in trial NCT05401357?
The interventions under investigation include: Test - Bimatoprost 0.01% Ophthalmic Solution (DRUG), Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution) (DRUG).
Who is sponsoring clinical trial NCT05401357?
This trial is sponsored by Amneal Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05401357 being conducted?
This trial has 9 study locations across California, Florida, Georgia, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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