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

Phase 3CompletedNCT01794312

Laboratoires Thea152 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

152

Conditions

Keratitis Corneal Ulcer

Interventions

T4020DEVICE

VehicleDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 Years

Medical Language ↔ Plain English

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.

Locations (1)

Clinical Development Director

Clermont-Ferrand, France

Outcomes

Primary Outcomes

Number of Participants With a Reduction in Neurotrophic the Keratitis/Ulcer Area on Day28

Reduction in neurotrophic ulcer/keratitis area of 50% or more

Time frame: Day 28

Secondary Outcomes

Number of Participants With at Least One Treatment-emergent Adverse Event

With at least one TEAE

Time frame: From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days

Best Corrected Visual Acuity

Change from baseline in far best-corrected visual acuity (LogMAR) in the pathologic eye

Time frame: Baseline and Day 28

Data from ClinicalTrials.gov

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