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NCT01794312 Clinical Trial

Efficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal Ulcer

Corneal Ulcer Clinical Trial

Official title:
Efficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal Ulcer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01794312
Other study ID # LT4020-PIII-12/11
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date February 2013
Est. completion date December 19, 2017

Study information
Verified date October 2019
Source Laboratoires Thea
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy and safety of T4020 versus vehicle.

Recruitment information / eligibility
Status Completed
Enrollment 152
Est. completion date December 19, 2017
Est. primary completion date December 19, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 95 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• T4020

• Vehicle

Locations
Country Name City State
France Clinical Development Director Clermont-Ferrand

Sponsors (1)
Lead Sponsor Collaborator
Laboratoires Thea

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants With a Reduction in Neurotrophic the Keratitis/Ulcer Area on Day28 Reduction in neurotrophic ulcer/keratitis area of 50% or more Day 28
Secondary Number of Participants With at Least One Treatment-emergent Adverse Event With at least one TEAE From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Secondary Best Corrected Visual Acuity Change from baseline in far best-corrected visual acuity (LogMAR) in the pathologic eye Baseline and Day 28
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