Back to resultsSafety Assessment of T4090 Eye Drops in Ocular Hypertensive or Glaucomatous Patients.
Primary Purpose
Glaucoma, Ocular Hypertension
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Kinezodianone R hydrochloride
Placebo
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 6 months
- Known or suspected hypersensitivity to one of the components of the Investigational Medicinal Product(s)
- Pregnancy or breast-feeding
Sites / Locations
- Dr EL-HARAZIRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
T4090
Placebo
Arm Description
named "Vehicle" in the study protocol.
Outcomes
Primary Outcome Measures
Ocular and systemic adverse events
Ocular and systemic treatment-emergent adverse events, serious TEAE, IMP-related TEAE, TEAE leading to premature IMP discontinuation.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05389267
Brief Title
Safety Assessment of T4090 Eye Drops in Ocular Hypertensive or Glaucomatous Patients.
Official Title
Safety Assessment of T4090 Eye Drops in Ocular Hypertensive or Glaucomatous Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2022 (Actual)
Primary Completion Date
June 15, 2023 (Anticipated)
Study Completion Date
June 30, 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
Yes
5. Study Description
Brief Summary
The study purpose is to evaluate the safety of T4090.
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 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
T4090
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
named "Vehicle" in the study protocol.
Intervention Type
Drug
Intervention Name(s)
Kinezodianone R hydrochloride
Intervention Description
Eyedrops
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Ocular and systemic adverse events
Description
Ocular and systemic treatment-emergent adverse events, serious TEAE, IMP-related TEAE, TEAE leading to premature IMP discontinuation.
Time Frame
up to 22 days
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 6 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
+33 473981436
Email
Corentin.LECAMUS@theapharma.com
Facility Information:
Facility Name
Dr EL-HARAZI
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherif El-Harazi, MD, MPH
12. IPD Sharing Statement
Learn more about this trial
Safety Assessment of T4090 Eye Drops in Ocular Hypertensive or Glaucomatous Patients.
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