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

Completed · Phase 3

Conditions studied: Glaucoma, Ocular Hypertension

In brief

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

Key facts

Study ID

NCT05397600

Run by

Laboratoires Thea

People needed

684

Starts

2022-06-22

Expected to finish

2024-03-07

Last updated by the study team

2024-07-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• 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
• Sage Eyecare — Los Angeles, California, United States
• Global Vision Eye Care - Los Angeles- Rock Central — Los Angeles, California, United States
• North Valley Eye Medical Group, Inc. — Mission Hills, California, United States
• California Eye Specialists Medical Group Inc. - Monrovia — Monrovia, California, United States
• Aesthetic Eye Care Institute - Eye Research Foundation — Newport Beach, California, United States
• Foothill Eye Institute - Pasadena — Pasadena, California, United States
• North Bay Eye Associates - Petaluma - 104 Lynch Creek Way — Petaluma, California, United States
• California Eye Specialists Medical Group Inc. - Redlands — Redlands, California, United States
• OC Surgical Eye Institute — Santa Ana, California, United States
• Santa Barbara Eyecare - Santa Barbara — Santa Barbara, California, United States
• Wolstan & Goldberg Eye Associates — Torrance, California, United States
• ICON Eye Care - Grand Junction — Grand Junction, Colorado, United States
• Nature Coast Clinical Research - Crystal River — Crystal River, Florida, United States
• East Coast Institute for Research - Jacksonville — Jacksonville, Florida, United States
• Ocala Eye - 3130 Location — Ocala, Florida, United States
• Arizona Eye Center - Chandler — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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