Clinical trial NCT06394973: Efficacy and Safety Assessment of T4090 Ophthalmic Solution Versus Rhopressa® Ophthalmic Solution in Patients with Open-angle Glaucoma or Ocular Hypertension
Official title: Efficacy and Safety Assessment of T4090 Ophthalmic Solution (preservative-free Kinezodianone R HCl 0.2% or 0.3%) Versus Rhopressa® Ophthalmic Solution (preserved Netarsudil 0.02%) in Patients with Open-angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2024-05-01
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Main Inclusion Criteria:

* Patient (male or female) ≥18 years old
* Patient with Open Angle Glaucoma or Ocular Hypertension in both eyes
* Informed consent dated and signed.

Main Exclusion Criteria:

* 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.

Primary outcomes:
measure: IOP Assessment
timeFrame: The primary efficacy endpoint is the change from baseline (D1) at Week 7 in the mean diurnal IOP in the study eye.
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Arizona Advanced Eye Research Institute
state: Arizona
city: Glendale
country: United States
facility: Global Research Management, Inc.
state: California
city: Inglewood
country: United States
facility: United Medical Research Institute
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Newport Beach
country: United States
facility: Visionary Research Institute
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates
state: California
city: Sacramento
country: United States
facility: Sacramento Eye Consultants, A Medical Corporation
state: California
city: Torrance
country: United States
facility: Wolstan and Goldberg Eye Associates
state: California
city: Delray Beach
country: United States
facility: Segal Drug Trials, Inc
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Research, LLC
state: Florida
city: Largo
country: United States
facility: Shettle Eye Research, Inc.
state: Florida
city: Mount Dora
country: United States
facility: Mild Florida Eye Center
state: Florida
city: Roswell
country: United States
facility: Coastal Research Associates, LLC
state: Georgia
city: Havre De Grace
country: United States
facility: Seidenberg Protzko Eye Associates
state: Maryland
city: Poughkeepsie
country: United States
facility: Alterman, Modi and Wolter Ophthalmic Surgeons
state: New York
city: Winston-Salem
country: United States
facility: James D. Branch, MD
state: North Carolina
city: Memphis
country: United States
facility: Total Eye Care, PA
state: Tennessee
city: Austin
country: United States
facility: Keystone Research
state: Texas
city: Dallas
country: United States
facility: Glaucoma Associates of Texas
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: Mission
country: United States
facility: DCT-Shah Research, LLC sba Discovery Clinical Trials
state: Texas
city: Falls Church
country: United States
facility: Emerson Clinical Research Institute
state: Virginia
city: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
Study officials:
References: