Efficacy and Safety Assessment of T4090 Ophthalmic Solution Versus Rhopressa® Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension
NCT ID: NCT06394973
Last Updated: 2026-01-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
161 participants
INTERVENTIONAL
2024-08-05
2024-11-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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T4090 0.2%
T4090 0.2%
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).
T4090 0.3%
T4090 0.3%
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).
Rhopressa®
Rhopressa®
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).
Interventions
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T4090 0.2%
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).
T4090 0.3%
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).
Rhopressa®
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
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Inclusion Criteria
* Patient with Open Angle Glaucoma or Ocular Hypertension in both eyes
* Informed consent dated and signed.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Laboratoires Thea
INDUSTRY
Responsible Party
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Locations
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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
Mt. 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
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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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LT4090-201
Identifier Type: -
Identifier Source: org_study_id
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