Clinical trial

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

Name

LT4090-201

Description

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

Trial arms

Trial start

2024-06-01

Estimated PCD

2025-05-01

Trial end

2025-05-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

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).

Arms:

T4090 0.2%

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).

Arms:

T4090 0.3%

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).

Arms:

Rhopressa®

Size

126

Primary endpoint

IOP Assessment

The primary efficacy endpoint is the change from baseline (D1) at Week 7 in the mean diurnal IOP in the study eye.

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 126, 'type': 'ESTIMATED'}}

Updated at

2024-05-01

1 organization

2 products

2 indications

Organization

Product

Indication

Indication

Product