Performance and Safety Assessment of T4020 in Managing Corneal Epithelial Defect Following Epi-off Accelerated Crosslinking
Not Applicable
Completed
- Conditions
- Keratoconus
- Interventions
- Device: T4020Device: Placebo
- Registration Number
- NCT02979054
- Lead Sponsor
- Laboratoires Thea
- Brief Summary
The purpose of this study is to assess the performance and safety of T4020 versus saline solution.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 157
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description T4020 T4020 1 drop every other day during 5 days Saline solution Placebo 1 drop every other day during 5 days
- Primary Outcome Measures
Name Time Method Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 3 Day 3 Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 4 Day 4
- Secondary Outcome Measures
Name Time Method Number of Participants With Treatment-emergent Adverse Events Through study completion, an average of 1 month Corneal Epithelial Defect Size Assessment Baseline and Day 5
Trial Locations
- Locations (3)
Erciyes Üniversitesi Tıp Fakültesi
🇹🇷Kayseri, Turkey
Hospital
🇪🇸Vigo, Spain
CHU
🇫🇷Clermont Ferrand, France