Efficacy and Safety Assessment of T4090 Ophthalmic Solution Versus Rhopressa® Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension

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

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

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Glaucoma
• Intervention / Treatment: Drug: T4090 0.2%; Drug: T4090 0.3%; Drug: Rhopressa®

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Arizona Advanced Eye Research Institute
  • California
    • Glendale, California, United States, 91204
      • Global Research Management, Inc.
    • Inglewood, California, United States, 90301
      • United Medical Research Institute
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation
    • Newport Beach, California, United States, 92663
      • Visionary Research Institute
    • Petaluma, California, United States, 94954
      • North Bay Eye Associates
    • Sacramento, California, United States, 95815
      • Sacramento Eye Consultants, A Medical Corporation
    • Torrance, California, United States, 90505
      • Wolstan and Goldberg Eye Associates
  • Florida
    • Delray Beach, Florida, United States, 33484
      • Segal Drug Trials, Inc
    • Jacksonville, Florida, United States, 32256
      • East Coast Institute for Research, LLC
    • Largo, Florida, United States, 33773
      • Shettle Eye Research, Inc.
    • Mt. Dora, Florida, United States, 32757
      • Mild Florida Eye Center
  • Georgia
    • Roswell, Georgia, United States, 30076
      • Coastal Research Associates, LLC
  • Maryland
    • Havre de Grace, Maryland, United States, 21078
      • Seidenberg Protzko Eye Associates
  • New York
    • Poughkeepsie, New York, United States, 12603
      • Alterman, Modi and Wolter Ophthalmic Surgeons
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27101
      • James D. Branch, MD
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care, PA
  • Texas
    • Austin, Texas, United States, 78731
      • Keystone Research
    • Dallas, Texas, United States, 75231
      • Glaucoma Associates Of Texas
    • Houston, Texas, United States, 77008
      • Houston Eye Associates
    • Houston, Texas, United States, 53719
      • Houston Eye Associates
    • Mission, Texas, United States, 78572
      • DCT-Shah Research, LLC sba Discovery Clinical Trials
  • Virginia
    • Falls Church, Virginia, United States, 22046
      • Emerson Clinical Research Institute
    • Lynchburg, Virginia, United States, 24502
      • Piedmont Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: T4090 0.2%	Drug: 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).
Experimental: T4090 0.3%	Drug: 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).
Active Comparator: Rhopressa®	Drug: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Laboratoires Thea

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2024
• Primary Completion (Actual): November 21, 2024
• Study Completion (Actual): November 21, 2024

Study Registration Dates

• First Submitted: April 29, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Ocular Hypertension
• Other Study ID Numbers: LT4090-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No