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

Phase 2

Active, not recruiting

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: T4090 0.2%; Drug: T4090 0.3%; Drug: Rhopressa®

• 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

Study Timeline

• Study First Submitted: 2024-04-29
• Study First Submitted QC: 2024-04-29
• Study First Posted: 2024-05-01
• Study Start: 2024-08-05
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-04
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 126

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 & 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.

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

Scroll for more (13 remaining)