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

Thea Pharma

Status and phase: Active, not recruiting; Phase 2

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: Rhopressa®; Drug: T4090 0.3%; Drug: T4090 0.2%

Study type: Interventional

Funder types: Industry

Identifiers

NCT06394973

LT4090-201

Details and patient eligibility

About

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

Enrollment: 126 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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126 participants in 3 patient groups

T4090 0.2%

Experimental group

Treatment:

Drug: T4090 0.2%

T4090 0.3%

Experimental group

Treatment:

Drug: T4090 0.3%

Rhopressa®

Active Comparator group

Treatment:

Drug: Rhopressa®