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

Phase 3

Completed

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: Bimatoprost Ophthalmic

• Registration Number: NCT05397600
• Lead Sponsor: Laboratoires Thea

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-25
• Study First Submitted QC: 2022-05-27
• Study First Posted: 2022-05-31
• Study Start: 2022-06-22
• Status Verified: 2023-11
• Primary Completion: 2024-03-07
• Study Completion: 2024-03-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 684

Inclusion Criteria

• Informed consent dated and signed.
• Both eyes diagnosed open-angle glaucoma or ocular hypertension

Exclusion Criteria

• History of trauma, infection, clinically significant inflammation within the previous 3 months
• Known or suspected hypersensitivity to one of the components of the Investigational Medicinal Product(s)
• Pregnancy or breast-feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T4032	Bimatoprost Ophthalmic	-
Lumigan	Bimatoprost Ophthalmic	-

Primary Outcome Measures

Name	Time	Method
Change from baseline (Day 1) to Week 2, Week 6, and Week 12 in IOP.	up to Week12	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.

Trial Locations

Locations (63)

Arizona Eye Center - Chandler; 🇺🇸 Chandler, Arizona, United States

Eye Physicians & Surgeons of Arizona - Glendale Office; 🇺🇸 Glendale, Arizona, United States

Arizona Glaucoma Specialists - Phoenix; 🇺🇸 Phoenix, Arizona, United States

Walman Eye Center - Sun City; 🇺🇸 Sun City, Arizona, United States

Velvet Clinical Research; 🇺🇸 Burbank, California, United States

Specialty Eye Care Medical Center - Glendale; 🇺🇸 Glendale, California, United States

Global Research Management, Inc.; 🇺🇸 Glendale, California, United States

Inland Eye Specialists - Hemet; 🇺🇸 Hemet, California, United States

Diabetic Eye Medical Clinic - Inglewood; 🇺🇸 Inglewood, California, United States

Lakeside Vision Center - Irvine; 🇺🇸 Irvine, California, United States

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