Back to resultsEfficacy and Safety Assessment of T4032 Versus Lumigan® in Ocular Hypertensive or Glaucomatous Patients
Primary Purpose
Ocular Hypertension, Glaucoma
Status
Completed
Phase
Phase 3
Locations
Estonia
Study Type
Interventional
Intervention
Bimatoprost
Lumigan®
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Hypertension
Eligibility Criteria
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.
Sites / Locations
- Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
T4032
Lumigan®
Arm Description
Outcomes
Primary Outcome Measures
Intra-Ocular Pressure
Change from Baseline to Week 12 in Intra Ocular Pressure in mmHg in the worse eye
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03825380
Brief Title
Efficacy and Safety Assessment of T4032 Versus Lumigan® in Ocular Hypertensive or Glaucomatous Patients
Official Title
Efficacy and Safety Assessment of T4032 Versus Lumigan® in Ocular Hypertensive or Glaucomatous Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 23, 2018 (Actual)
Primary Completion Date
February 3, 2021 (Actual)
Study Completion Date
February 24, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoires Thea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the efficacy and safety of T4032 versus Lumigan.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension, Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
485 (Actual)
8. Arms, Groups, and Interventions
Arm Title
T4032
Arm Type
Experimental
Arm Title
Lumigan®
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Bimatoprost
Intervention Description
Eyedrops
Intervention Type
Drug
Intervention Name(s)
Lumigan®
Intervention Description
Eyedrops
Primary Outcome Measure Information:
Title
Intra-Ocular Pressure
Description
Change from Baseline to Week 12 in Intra Ocular Pressure in mmHg in the worse eye
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital
City
Tallinn
Country
Estonia
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Assessment of T4032 Versus Lumigan® in Ocular Hypertensive or Glaucomatous Patients
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