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

The study purpose is to evaluate the safety of T4090.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Dr EL-HARAZI

Glendale, California, 91204, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kinezodianone R hydrochloride

Drug

Eyedrops

Placebo

Drug

Placebo

Primary outcomes

Ocular and systemic adverse events

Time frame: up to 22 days

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

Sponsors and collaborators

Lead sponsor

Laboratoires Thea

Industry

Registry information

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: May 25, 2022
Registry last updated: Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting