Back to resultsEfficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal Ulcer
Primary Purpose
Keratitis, Corneal Ulcer
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
T4020
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Keratitis
Eligibility Criteria
Inclusion Criteria:
- Adult patients diagnosed with one chronic keratitis/corneal ulcer
- Patients who signed and dated informed consent
Exclusion Criteria:
- Patient under 18 years
- Patient with a perforated corneal ulcer OR any risk of immediate perforation of corneal ulcer.
Sites / Locations
- Clinical Development Director
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
T4020
Vehicle
Arm Description
One drop every 2 days
One drop every 2 days
Outcomes
Primary Outcome Measures
Number of Participants With a Reduction in Neurotrophic the Keratitis/Ulcer Area on Day28
Reduction in neurotrophic ulcer/keratitis area of 50% or more
Secondary Outcome Measures
Number of Participants With at Least One Treatment-emergent Adverse Event
With at least one TEAE
Best Corrected Visual Acuity
Change from baseline in far best-corrected visual acuity (LogMAR) in the pathologic eye
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01794312
Brief Title
Efficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal Ulcer
Official Title
Efficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal Ulcer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
February 2013 (Actual)
Primary Completion Date
December 19, 2017 (Actual)
Study Completion Date
December 19, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoires Thea
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to assess the efficacy and safety of T4020 versus vehicle.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratitis, Corneal Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
152 (Actual)
8. Arms, Groups, and Interventions
Arm Title
T4020
Arm Type
Experimental
Arm Description
One drop every 2 days
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
One drop every 2 days
Intervention Type
Device
Intervention Name(s)
T4020
Intervention Type
Device
Intervention Name(s)
Vehicle
Primary Outcome Measure Information:
Title
Number of Participants With a Reduction in Neurotrophic the Keratitis/Ulcer Area on Day28
Description
Reduction in neurotrophic ulcer/keratitis area of 50% or more
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Number of Participants With at Least One Treatment-emergent Adverse Event
Description
With at least one TEAE
Time Frame
From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Title
Best Corrected Visual Acuity
Description
Change from baseline in far best-corrected visual acuity (LogMAR) in the pathologic eye
Time Frame
Baseline and Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients diagnosed with one chronic keratitis/corneal ulcer
Patients who signed and dated informed consent
Exclusion Criteria:
Patient under 18 years
Patient with a perforated corneal ulcer OR any risk of immediate perforation of corneal ulcer.
Facility Information:
Facility Name
Clinical Development Director
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal Ulcer
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