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

October 11, 2019 updated by: Laboratoires Thea
The purpose of this study is to assess the efficacy and safety of T4020 versus vehicle.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63000
        • Clinical Development Director

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: T4020
One drop every 2 days
Device: T4020
PLACEBO_COMPARATOR: Vehicle
One drop every 2 days
Device: Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With a Reduction in Neurotrophic the Keratitis/Ulcer Area on Day28
Time Frame: Day 28
Reduction in neurotrophic ulcer/keratitis area of 50% or more
Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With at Least One Treatment-emergent Adverse Event
Time Frame: 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
From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Best Corrected Visual Acuity
Time Frame: Baseline and Day 28
Change from baseline in far best-corrected visual acuity (LogMAR) in the pathologic eye
Baseline and Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoires Thea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2013

Primary Completion (ACTUAL)

December 19, 2017

Study Completion (ACTUAL)

December 19, 2017

Study Registration Dates

First Submitted

January 25, 2013

First Submitted That Met QC Criteria

February 15, 2013

First Posted (ESTIMATE)

February 18, 2013

Study Record Updates

Last Update Posted (ACTUAL)

October 23, 2019

Last Update Submitted That Met QC Criteria

October 11, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT4020-PIII-12/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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