Efficacy and Safety Assessment of T4090 Ophthalmic Solution Versus Rhopressa® Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension
1 other identifier
interventional
161
1 country
24
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2024
Shorter than P25 for phase_2
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2024
CompletedFirst Posted
Study publicly available on registry
May 1, 2024
CompletedStudy Start
First participant enrolled
August 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 21, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 21, 2024
CompletedResults Posted
Study results publicly available
January 2, 2026
CompletedJanuary 2, 2026
December 1, 2025
4 months
April 29, 2024
September 22, 2025
December 11, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Diurnal IOP
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. Mean diurnal is calculated from these three timepoints.
The primary efficacy endpoint is the change from baseline (D1) at Week 7 in the mean diurnal IOP in the study eye.
Study Arms (3)
T4090 0.2%
EXPERIMENTALT4090 0.3%
EXPERIMENTALRhopressa®
ACTIVE COMPARATORInterventions
1 drop in the conjunctival cul-de-sac of each eye once daily at 8:00 PM (±1 hour) from Day 1 to the day before the End of treatment visit (Visit #5 - Week 7).
1 drop in the conjunctival cul-de-sac of each eye once daily at 8:00 PM (±1 hour) from Day 1 to the day before the End of treatment visit (Visit #5 - Week 7).
1 drop in the conjunctival cul-de-sac of each eye once daily at 8:00 PM (±1 hour) from Day 1 to the day before the End of treatment visit (Visit #5 - Week 7).
Eligibility Criteria
You may qualify if:
- Patient (male or female) ≥18 years old
- Patient with Open Angle Glaucoma or Ocular Hypertension in both eyes
- Informed consent dated and signed.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Arizona Advanced Eye Research Institute
Glendale, Arizona, 85306, United States
Global Research Management, Inc.
Glendale, California, 91204, United States
United Medical Research Institute
Inglewood, California, 90301, United States
Eye Research Foundation
Newport Beach, California, 92663, United States
Visionary Research Institute
Newport Beach, California, 92663, United States
North Bay Eye Associates
Petaluma, California, 94954, United States
Sacramento Eye Consultants, A Medical Corporation
Sacramento, California, 95815, United States
Wolstan and Goldberg Eye Associates
Torrance, California, 90505, United States
Segal Drug Trials, Inc
Delray Beach, Florida, 33484, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, 32256, United States
Shettle Eye Research, Inc.
Largo, Florida, 33773, United States
Mild Florida Eye Center
Mt. Dora, Florida, 32757, United States
Coastal Research Associates, LLC
Roswell, Georgia, 30076, United States
Seidenberg Protzko Eye Associates
Havre de Grace, Maryland, 21078, United States
Alterman, Modi and Wolter Ophthalmic Surgeons
Poughkeepsie, New York, 12603, United States
James D. Branch, MD
Winston-Salem, North Carolina, 27101, United States
Total Eye Care, PA
Memphis, Tennessee, 38119, United States
Keystone Research
Austin, Texas, 78731, United States
Glaucoma Associates of Texas
Dallas, Texas, 75231, United States
Houston Eye Associates
Houston, Texas, 53719, United States
Houston Eye Associates
Houston, Texas, 77008, United States
DCT-Shah Research, LLC sba Discovery Clinical Trials
Mission, Texas, 78572, United States
Emerson Clinical Research Institute
Falls Church, Virginia, 22046, United States
Piedmont Eye Center
Lynchburg, Virginia, 24502, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Affairs Director
- Organization
- Laboratoires Théa
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2024
First Posted
May 1, 2024
Study Start
August 5, 2024
Primary Completion
November 21, 2024
Study Completion
November 21, 2024
Last Updated
January 2, 2026
Results First Posted
January 2, 2026
Record last verified: 2025-12