Phase 3
Completed N=152
Efficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal Ulcer
Keratitis · Corneal Ulcer
Source: ClinicalTrials.gov NCT01794312 ↗
Enrolled (actual)
152
Serious AEs
6.6%
Results posted
Oct 2019
Primary outcomePrimary: Number of Participants With a Reduction in Neurotrophic the Keratitis/Ulcer Area on Day28 — 37; 44 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to assess the efficacy and safety of T4020 versus vehicle.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Reduction in Neurotrophic the Keratitis/Ulcer Area on Day28 |
37; 44 | — |
| SECONDARY Number of Participants With at Least One Treatment-emergent Adverse Event |
25; 27 | — |
| SECONDARY Best Corrected Visual Acuity |
-0.055; -0.035 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01794312). 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.