Efficacy and Safety Assessment of T4032 Versus Lumigan® in Ocular Hypertensive or Glaucomatous Patients

The purpose of this study is to assess the efficacy and safety of T4032 versus Lumigan.

Completed

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Key information

Conditions

Ocular Hypertension Eye Diseases Glaucoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital

Tallinn, Estonia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Informed consent signed and dated.
Both eyes with diagnosed open-angle glaucoma or ocular hypertension

Exclusion criteria

History of trauma, infection, clinically significant inflammation within the 3 previous months.
Uncontrolled diabetic patient.
Pregnancy or breast feeding.

Treatment and study plan

Bimatoprost

Drug

Eyedrops

Lumigan®

Drug

Eyedrops

Primary outcomes

Intra-Ocular Pressure

Time frame: Week 12

Change from Baseline to Week 12 in Intra Ocular Pressure in mmHg in the worse eye

Sponsors and collaborators

Lead sponsor

Laboratoires Thea

Industry

Registry information

Important dates

Study start: 2018
Primary completion: 2021
Study completion: 2021
First posted: Jan 31, 2019
Registry last updated: Nov 21, 2023

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.

Completed