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COMPLETED Phase 3

Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients

NCT05397600 · View on ClinicalTrials.gov ↗

Study Summary

The main study purpose is to demonstrate the non-inferiority of T4032 compared to Lumigan® 0.01% in terms of efficacy.

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

FieldValue
Enrollment Target 684 participants
Start Date 2022-06-22
Est. Completion 2024-03-07
Phase Phase 3

Sponsor

Laboratoires Thea

32 total trials

Interested in This Trial?

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05397600

The ClinicalTrials.gov registry entry for NCT05397600 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 684 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Laboratoires Thea, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05397600 reports 20 study locations spanning 2 distinct geographic areas — top geographies include California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05397600?

The interventions under investigation include: Bimatoprost Ophthalmic (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05397600?

This trial is sponsored by Laboratoires Thea, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial