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

Phase 3

Completed

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: Bimatoprost; Drug: Lumigan®

• Registration Number: NCT03825380
• Lead Sponsor: Laboratoires Thea

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-23
• Study First Submitted: 2019-01-21
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-01-31
• Primary Completion: 2021-02-03
• Study Completion: 2021-02-24
• Results First Submitted: 2022-05-12
• Status Verified: 2023-02
• Results First Submitted QC: 2023-02-09
• Last Update Submitted: 2023-02-09
• Results First Posted: 2023-11-21
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 485

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T4032	Bimatoprost	-
Lumigan®	Lumigan®	-

Primary Outcome Measures

Name	Time	Method
Intra-Ocular Pressure	Week 12	Change from Baseline to Week 12 in Intra Ocular Pressure in mmHg in the worse eye

Trial Locations

Locations (1)

Hospital; 🇪🇪 Tallinn, Estonia