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NCT05397600 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients
A Phase 3 study of Glaucoma and Ocular Hypertension, sponsored by Laboratoires Thea.
- Completed
- Registry status
- Phase 3
- Development phase
- 684
- Enrollment target
- 20
- Study locations
NCT05397600: Completed Phase 3 study of Glaucoma and Ocular Hypertension, sponsored by Laboratoires Thea.
NCT05397600 is a Phase 3 study of Glaucoma and Ocular Hypertension that has completed, run by Laboratoires Thea. The registered enrollment target is 684 participants, below the 903-participant average among 92 other Glaucoma trials with a reported enrollment target (24% lower). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05397600, a Phase 3 study of Glaucoma and Ocular Hypertension, has completed, sponsored by Laboratoires Thea.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 684 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main study purpose is to demonstrate the non-inferiority of T4032 compared to Lumigan® 0.01% in terms of efficacy.
Primary Outcome
Change from baseline (Day 1) to Week 2, Week 6, and Week 12 in IOP at three time points (8:00 a.m.; 10:00 a.m.; 4:00 p.m.) in the study eye.
Conditions Studied
Interventions
- DRUG Bimatoprost Ophthalmic
Study Locations (20)
California
- Velvet Clinical Research - Burbank
- Specialty Eye Care Medical Center - Glendale - Glendale
- Global Research Management, Inc. - Glendale
- Inland Eye Specialists - Hemet - Hemet
- Diabetic Eye Medical Clinic - Inglewood - Inglewood
- Lakeside Vision Center - Irvine - Irvine
- Sage Eyecare - Los Angeles
- Global Vision Eye Care - Los Angeles- Rock Central - Los Angeles
- North Valley Eye Medical Group, Inc. - Mission Hills
- California Eye Specialists Medical Group Inc. - Monrovia - Monrovia
- Aesthetic Eye Care Institute - Eye Research Foundation - Newport Beach
- Foothill Eye Institute - Pasadena - Pasadena
- North Bay Eye Associates - Petaluma - 104 Lynch Creek Way - Petaluma
- California Eye Specialists Medical Group Inc. - Redlands - Redlands
- OC Surgical Eye Institute - Santa Ana
- Santa Barbara Eyecare - Santa Barbara - Santa Barbara
Arizona
- Arizona Eye Center - Chandler - Chandler
- Eye Physicians & Surgeons of Arizona - Glendale Office - Glendale
- Arizona Glaucoma Specialists - Phoenix - Phoenix
- Walman Eye Center - Sun City - Sun City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 684 participants |
| Start Date | 2022-06-22 |
| Est. Completion | 2024-03-07 |
| Phase | Phase 3 |
What the finished NCT05397600 record still lists
NCT05397600 is an interventional study that assigns participants to a tested intervention. The registered 684 participants enrollment target is mid-sized for trials with a published cap, below the 903-participant average among 92 other Glaucoma trials with a reported enrollment target (24% lower).
The record links to 2 conditions, with Glaucoma appearing as the primary indexed condition, and to 1 intervention - of which Bimatoprost Ophthalmic is the first listed.
NCT05397600 names 20 study sites across 2 states, led by California, Arizona.
Frequently Asked Questions
What is clinical trial NCT05397600 about?
NCT05397600 is a clinical study titled "Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients". The main study purpose is to demonstrate the non-inferiority of T4032 compared to Lumigan® 0.01% in terms of efficacy.
What is the current status of trial NCT05397600?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 684 participants. The study started on 2022-06-22. Estimated completion is 2024-03-07.
What conditions does trial NCT05397600 study?
This clinical trial studies the following conditions: Glaucoma, Ocular Hypertension.
What interventions are being tested in trial NCT05397600?
The interventions under investigation include: Bimatoprost Ophthalmic (DRUG).
Who is sponsoring clinical trial NCT05397600?
This trial is sponsored by Laboratoires Thea, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05397600 being conducted?
This trial has 20 study locations across Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Glaucoma
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 NCT05397600's enrollment target sits among peer trials
684 9th of 92 higher than 84 of 92 other Glaucoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glaucoma 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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