Back to resultsPerformance and Safety Assessment of T4020 in Managing Corneal Epithelial Defect Following Epi-off Accelerated Crosslinking
Primary Purpose
Keratoconus
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
T4020
Placebo
Sponsored by
About this trial
This is an interventional other trial for Keratoconus
Eligibility Criteria
Inclusion Criteria:
- Adult patients diagnosed with progressive keratoconus
- Patients who signed and dated informed consent
Exclusion Criteria:
- Patient under 18 years
- History within 1 month or any active ocular infection, ocular injury, and associated corneal ulceration and abscess
- Corneal thickness< 400µm
Sites / Locations
- Hospital
- CHU
- Hospital
- Erciyes Üniversitesi Tıp Fakültesi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
T4020
Saline solution
Arm Description
1 drop every other day during 5 days
1 drop every other day during 5 days
Outcomes
Primary Outcome Measures
Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 3
Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 4
Secondary Outcome Measures
Corneal Epithelial Defect Size Assessment
Number of Participants With Treatment-emergent Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02979054
Brief Title
Performance and Safety Assessment of T4020 in Managing Corneal Epithelial Defect Following Epi-off Accelerated Crosslinking
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoires Thea
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the performance and safety of T4020 versus saline solution.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
157 (Actual)
8. Arms, Groups, and Interventions
Arm Title
T4020
Arm Type
Experimental
Arm Description
1 drop every other day during 5 days
Arm Title
Saline solution
Arm Type
Placebo Comparator
Arm Description
1 drop every other day during 5 days
Intervention Type
Device
Intervention Name(s)
T4020
Intervention Type
Device
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 3
Time Frame
Day 3
Title
Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 4
Time Frame
Day 4
Secondary Outcome Measure Information:
Title
Corneal Epithelial Defect Size Assessment
Time Frame
Baseline and Day 5
Title
Number of Participants With Treatment-emergent Adverse Events
Time Frame
Through study completion, an average of 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients diagnosed with progressive keratoconus
Patients who signed and dated informed consent
Exclusion Criteria:
Patient under 18 years
History within 1 month or any active ocular infection, ocular injury, and associated corneal ulceration and abscess
Corneal thickness< 400µm
Facility Information:
Facility Name
Hospital
City
Varna
Country
Bulgaria
Facility Name
CHU
City
Clermont Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Hospital
City
Vigo
Country
Spain
Facility Name
Erciyes Üniversitesi Tıp Fakültesi
City
Kayseri
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Performance and Safety Assessment of T4020 in Managing Corneal Epithelial Defect Following Epi-off Accelerated Crosslinking
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