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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: Recruiting Phase 3 study of Ocular Hypertension and Glaucoma Open-Angle, sponsored by Amneal Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in mean difference in the intraocular pressure (IOP) of both eyes between the two treatment groups at six time points, i.e., at 00.00 hour, 04.00 hours, and 08.00 hours at Day 14 (Week 2) and Day 42 (Week 6) visits
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 |
What NCT05401357 shows while recruiting
NCT05401357 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, below the 275-participant average among 54 other Ocular Hypertension trials with a reported enrollment target (39% lower).
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 lists 9 locations in 6 states (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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05401357's enrollment target sits among peer trials
168 27th of 54 higher than 28 of 54 other Ocular Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ocular Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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