Efficacy and Safety Assessment of T4090 Ophthalmic Solution Versus Rhopressa® Ophthalmic Solution in Patients with Open-angle Glaucoma or Ocular Hypertension
- Conditions
- GlaucomaOcular Hypertension
- Interventions
- Registration Number
- NCT06394973
- Lead Sponsor
- Laboratoires Thea
- Brief Summary
The main purpose is to compare the ocular hypotensive efficacy and safety of two concentrations of T4090 (Kinezodianone R HCl 0.2% and 0.3%) ophthalmic solution with Rhopressa® ophthalmic solution
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 126
- Patient (male or female) ≥18 years old
- Patient with Open Angle Glaucoma or Ocular Hypertension in both eyes
- Informed consent dated and signed.
Main
- Secondary Open Agle Glaucoma (ex. Pseudoexfoliation, Pigmentary glaucoma)
- Advanced stage of glaucoma
- History of ocular trauma, eye infection, or/and ocular clinically significant inflammation within the 6 previous months.
- Known or suspected hypersensitivity to one of the components of the IMPs or other product used in the clinical study
- Pregnancy (confirmed with a positive urine pregnancy test) or breast-feeding.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description T4090 0.2% T4090 0.2% - T4090 0.3% T4090 0.3% - Rhopressa® Rhopressa® -
- Primary Outcome Measures
Name Time Method IOP Assessment The primary efficacy endpoint is the change from baseline (D1) at Week 7 in the mean diurnal IOP in the study eye. IOP measurement with calibrated Goldmann applanation tonometer in each eye at three time points (8:00 AM; 10:00 AM; 4:00 PM) by the Investigator.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
Arizona Advanced Eye Research Institute
🇺🇸Glendale, Arizona, United States
Global Research Management, Inc.
🇺🇸Glendale, California, United States
United Medical Research Institute
🇺🇸Inglewood, California, United States
Eye Research Foundation
🇺🇸Newport Beach, California, United States
Visionary Research Institute
🇺🇸Newport Beach, California, United States
North Bay Eye Associates
🇺🇸Petaluma, California, United States
Sacramento Eye Consultants, A Medical Corporation
🇺🇸Sacramento, California, United States
Wolstan and Goldberg Eye Associates
🇺🇸Torrance, California, United States
Segal Drug Trials, Inc
🇺🇸Delray Beach, Florida, United States
East Coast Institute for Research, LLC
🇺🇸Jacksonville, Florida, United States
Shettle Eye Research, Inc.
🇺🇸Largo, Florida, United States
Mild Florida Eye Center
🇺🇸Mount Dora, Florida, United States
Coastal Research Associates, LLC
🇺🇸Roswell, Georgia, United States
Seidenberg Protzko Eye Associates
🇺🇸Havre De Grace, Maryland, United States
Alterman, Modi and Wolter Ophthalmic Surgeons
🇺🇸Poughkeepsie, New York, United States
James D. Branch, MD
🇺🇸Winston-Salem, North Carolina, United States
Total Eye Care, PA
🇺🇸Memphis, Tennessee, United States
Keystone Research
🇺🇸Austin, Texas, United States
Glaucoma Associates of Texas
🇺🇸Dallas, Texas, United States
Houston Eye Associates
🇺🇸Houston, Texas, United States
DCT-Shah Research, LLC sba Discovery Clinical Trials
🇺🇸Mission, Texas, United States
Emerson Clinical Research Institute
🇺🇸Falls Church, Virginia, United States
Piedmont Eye Center
🇺🇸Lynchburg, Virginia, United States