Completed
Efficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal Ulcer
What is being tested
T4020
+ Vehicle
Device
Who is being recruted
Corneal Diseases+3
+ Eye Diseases
+ Infections
From 18 to 95 Years
+4 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 3
Interventional
Study Start: February 2013
Summary
Principal SponsorLaboratoires Thea
Last updated: October 23, 2019
Sourced from a government-validated database.Claim as a partner
Study start date: February 1, 2013
Actual date on which the first participant was enrolled.The purpose of this study is to assess the efficacy and safety of T4020 versus vehicle.
Principal SponsorLaboratoires Thea
Last updated: October 23, 2019
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
152 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 95 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Corneal DiseasesEye DiseasesInfectionsEye InfectionsCorneal UlcerKeratitis
Criteria
2 inclusion criteria required to participate
Adult patients diagnosed with one chronic keratitis/corneal ulcer
Patients who signed and dated informed consent
2 exclusion criteria prevent from participating
Patient under 18 years
Patient with a perforated corneal ulcer OR any risk of immediate perforation of corneal ulcer
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalOne drop every 2 days
Group II
PlaceboOne drop every 2 days
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Clinical Development Director
Clermont-Ferrand, FranceOpen Clinical Development Director in Google MapsCompletedOne Study Center