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

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06394973
• Other study ID #: LT4090-201
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2024
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: Laboratoires Thea
• Contact: Corentin LE CAMUS
• Phone: +33473981436
• Email: Corentin.LECAMUS[@]theapharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 126
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension

Intervention

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).
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Thea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOP Assessment	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.	The primary efficacy endpoint is the change from baseline (D1) at Week 7 in the mean diurnal IOP in the study eye.