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NCT03825380 Clinical Trial

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

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03825380
Other study ID # LT4032-301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 23, 2018
Est. completion date February 24, 2021

Study information
Verified date February 2023
Source Laboratoires Thea
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 485
Est. completion date February 24, 2021
Est. primary completion date February 3, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bimatoprost
Eyedrops
• Lumigan®
Eyedrops

Locations
Country Name City State
Estonia Hospital Tallinn

Sponsors (1)
Lead Sponsor Collaborator
Laboratoires Thea

Country where clinical trial is conducted

Estonia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intra-Ocular Pressure Change from Baseline to Week 12 in Intra Ocular Pressure in mmHg in the worse eye Week 12
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