Safety Assessment of T4090 Eye Drops in Ocular Hypertensive or Glaucomatous Patients.

Phase 2Active Not RecruitingNCT05389267

Laboratoires Thea120 enrolled

Overview

The study purpose is to evaluate the safety of T4090.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Glaucoma Ocular Hypertension

Interventions

Kinezodianone R hydrochlorideDRUG

Eyedrops

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Informed consent dated and signed. * Both eyes diagnosed open-angle glaucoma or ocular hypertension Exclusion Criteria: * History of trauma, infection, clinically significant inflammation within the previous 6 months * Known or suspected hypersensitivity to one of the components of the Investigational Medicinal Product(s) * Pregnancy or breast-feeding

Locations (1)

Dr EL-HARAZI

Glendale, California, United States

Outcomes

Primary Outcomes

Ocular and systemic adverse events

Ocular and systemic treatment-emergent adverse events, serious TEAE, IMP-related TEAE, TEAE leading to premature IMP discontinuation.

Time frame: up to 22 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.