Back to resultsEfficacy and Safety Assessment of T4030 Eye Drops Versus Ganfort® UD in Ocular Hypertensive or Glaucomatous Patients.
Primary Purpose
Ocular Hypertension Glaucoma
Status
Completed
Phase
Phase 3
Locations
Bulgaria
Study Type
Interventional
Intervention
Bimatoprost Timolol (T4030)
Bimatoprost Timolol (Ganfort)
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Hypertension Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Informed consent signed and dated*
- Patient aged ≥18 years old
- Both eyes with a central corneal thickness assessment ≥500 µm and ≤600 μm a
- Both eyes with diagnosed ocular hypertension or open angle glaucoma
Exclusion Criteria:
- History of narrow angle and/or angle closure glaucoma
- Advanced stage of glaucoma
Sites / Locations
- Medical Center Vereya EOOD
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
T4030 Group
Ganfort Group
Arm Description
Outcomes
Primary Outcome Measures
IOP assessment
The primary efficacy endpoint is the change from Baseline (Day 1) to Week 12 in IOP
Secondary Outcome Measures
Ocular Sign
Ocular sign will be assessed through slit lamp examination at each visits
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04898387
Brief Title
Efficacy and Safety Assessment of T4030 Eye Drops Versus Ganfort® UD in Ocular Hypertensive or Glaucomatous Patients.
Official Title
Efficacy and Safety Assessment of T4030 Eye Drops Versus Ganfort® UD in Ocular Hypertensive or Glaucomatous Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 26, 2021 (Actual)
Primary Completion Date
April 13, 2023 (Actual)
Study Completion Date
May 30, 2023 (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
To demonstrate the non-inferiority of T4030 unpreserved eye drops compared to Ganfort® UD in terms of efficacy.
Detailed Description
Efficacy Parameters IOP assessment in each eye
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
Masking Description
The 2 different treatment kits should be identical in external packaging in order to respect the masked evaluation for efficacy and safety.
The identity of the IMP given to each patient will not be known by the masked investigator
Allocation
Randomized
Enrollment
554 (Actual)
8. Arms, Groups, and Interventions
Arm Title
T4030 Group
Arm Type
Experimental
Arm Title
Ganfort Group
Arm Type
Active Comparator
Intervention Type
Combination Product
Intervention Name(s)
Bimatoprost Timolol (T4030)
Other Intervention Name(s)
Bimatoprost Timolol
Intervention Description
Eye drop
Intervention Type
Combination Product
Intervention Name(s)
Bimatoprost Timolol (Ganfort)
Other Intervention Name(s)
Bimatoprost Timolol
Intervention Description
Eye drop
Primary Outcome Measure Information:
Title
IOP assessment
Description
The primary efficacy endpoint is the change from Baseline (Day 1) to Week 12 in IOP
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Ocular Sign
Description
Ocular sign will be assessed through slit lamp examination at each visits
Time Frame
Week 6 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*
Patient aged ≥18 years old
Both eyes with a central corneal thickness assessment ≥500 µm and ≤600 μm a
Both eyes with diagnosed ocular hypertension or open angle glaucoma
Exclusion Criteria:
History of narrow angle and/or angle closure glaucoma
Advanced stage of glaucoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CORENTIN LECAMUS
Organizational Affiliation
Laboratoires Thea
Official's Role
Study Director
Facility Information:
Facility Name
Medical Center Vereya EOOD
City
Stara Zagora
Country
Bulgaria
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety Assessment of T4030 Eye Drops Versus Ganfort® UD in Ocular Hypertensive or Glaucomatous Patients.
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