N/A
Completed N=135
Performance and Safety Assessment of T4020 in Managing Corneal Epithelial Defect Following Epi-off Accelerated Crosslinking
Source: ClinicalTrials.gov NCT02979054 ↗Enrolled (actual)
135
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 3 — 20; 25 Participants
Summary
The purpose of this study is to assess the performance and safety of T4020 versus saline solution.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 3 |
20; 25 | — |
| PRIMARY Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 4 |
47; 47 | — |
| SECONDARY Corneal Epithelial Defect Size Assessment |
1.0; 1.9 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events |
12; 8 | — |
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
Data sourced from ClinicalTrials.gov (NCT02979054). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.