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

Phase 1

Active, not recruiting

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: Placebo; Drug: Kinezodianone R hydrochloride

• Registration Number: NCT05389267
• Lead Sponsor: Laboratoires Thea

Brief Summary

The study purpose is to evaluate the safety of T4090.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-18
• Study First Submitted QC: 2022-05-24
• Study First Posted: 2022-05-25
• Study Start: 2022-07-05
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	named "Vehicle" in the study protocol.
T4090	Kinezodianone R hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Ocular and systemic adverse events	up to 22 days	Ocular and systemic treatment-emergent adverse events, serious TEAE, IMP-related TEAE, TEAE leading to premature IMP discontinuation.

Trial Locations

Locations (1)

Dr EL-HARAZI; 🇺🇸 Glendale, California, United States