Efficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal Ulcer
Phase 3
Completed
- Conditions
- KeratitisCorneal Ulcer
- Interventions
- Device: T4020Device: Vehicle
- Registration Number
- NCT01794312
- Lead Sponsor
- Laboratoires Thea
- Brief Summary
The purpose of this study is to assess the efficacy and safety of T4020 versus vehicle.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 152
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description T4020 T4020 One drop every 2 days Vehicle Vehicle One drop every 2 days
- Primary Outcome Measures
Name Time Method Number of Participants With a Reduction in Neurotrophic the Keratitis/Ulcer Area on Day28 Day 28 Reduction in neurotrophic ulcer/keratitis area of 50% or more
- Secondary Outcome Measures
Name Time Method Best Corrected Visual Acuity Baseline and Day 28 Change from baseline in far best-corrected visual acuity (LogMAR) in the pathologic eye
Number of Participants With at Least One Treatment-emergent Adverse Event From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days With at least one TEAE
Trial Locations
- Locations (1)
Clinical Development Director
š«š·Clermont-Ferrand, France