Back to resultsEfficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients
Primary Purpose
Glaucoma, Ocular Hypertension
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bimatoprost Ophthalmic
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
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 3 months
- Known or suspected hypersensitivity to one of the components of the Investigational Medicinal Product(s)
- Pregnancy or breast-feeding
Sites / Locations
- Scheie Eye Institute
- Southwest Eye InstituteRecruiting
- Clínica Oftalmológica del Caribe
- Fundación Oftalmológica Nacional (FUNDONAL)
- Clinica de Oftalmologia de Cali SA
- Fundación Oftalmológica de Santander FOSCAL
- Instituto Nacional de Investigacion en Oftalmologia
- Clinica de Oftalmologia Sandiego
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
T4032
Lumigan
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline (Day 1) to Week 2, Week 6, and Week 12 in IOP.
Change from baseline (Day 1) to Week 2, Week 6, and Week 12 in IOP at three time points (8:00 a.m.; 10:00 a.m.; 4:00 p.m.) in the study eye.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05397600
Brief Title
Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients
Official Title
Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
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
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main study purpose is to demonstrate the non-inferiority of T4032 compared to Lumigan® 0.01% in terms of efficacy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
500 (Anticipated)
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 Ophthalmic
Intervention Description
Eyedrops
Primary Outcome Measure Information:
Title
Change from baseline (Day 1) to Week 2, Week 6, and Week 12 in IOP.
Description
Change from baseline (Day 1) to Week 2, Week 6, and Week 12 in IOP at three time points (8:00 a.m.; 10:00 a.m.; 4:00 p.m.) in the study eye.
Time Frame
up to Week12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 3 months
Known or suspected hypersensitivity to one of the components of the Investigational Medicinal Product(s)
Pregnancy or breast-feeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Corentin LECAMUS
Phone
+33473981436
Email
Corentin.LECAMUS@theapharma.com
Facility Information:
Facility Name
Scheie Eye Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eydie Miller-Ellis
Facility Name
Southwest Eye Institute
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louis Alpern
Facility Name
Clínica Oftalmológica del Caribe
City
Barranquilla
ZIP/Postal Code
80001
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Rodriguez
Facility Name
Fundación Oftalmológica Nacional (FUNDONAL)
City
Bogotá
ZIP/Postal Code
110231
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra Belalcazar Rey
Facility Name
Clinica de Oftalmologia de Cali SA
City
Cali
ZIP/Postal Code
760001
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edgar Lozano
Facility Name
Fundación Oftalmológica de Santander FOSCAL
City
Floridablanca
ZIP/Postal Code
681004
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaun Camilo Parra Restrepo
Facility Name
Instituto Nacional de Investigacion en Oftalmologia
City
Medellin
ZIP/Postal Code
50024
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catalina Ramirez
Facility Name
Clinica de Oftalmologia Sandiego
City
Medellín
ZIP/Postal Code
50021
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Santiago Arango Velez
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients
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