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

This study is currently recruiting participants.
Verified November 2016 by Laboratoires Thea
Sponsor:
ClinicalTrials.gov Identifier:
NCT01794312
First Posted: February 18, 2013
Last Update Posted: November 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Laboratoires Thea
  Purpose
The purpose of this study is to assess the efficacy and safety of T4020 versus vehicle.

Condition Intervention Phase
Keratitis Corneal Ulcer Device: T4020 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal Ulcer

Resource links provided by NLM:


Further study details as provided by Laboratoires Thea:

Primary Outcome Measures:
  • evaluation of the keratitis/ulcer area [ Time Frame: Day 28 ]
    Evaluation of the corneal healing at Day 28 with the keratitis/ulcer area measures from baseline


Secondary Outcome Measures:
  • Number of adverse events recorded [ Time Frame: all visits ]
  • Best corrected visual acuity [ Time Frame: Day 28 ]

Estimated Enrollment: 124
Study Start Date: January 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: T4020
One drop 4 times per week
Device: T4020
Placebo Comparator: Vehicle
One drop 4 times per week
Device: T4020

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01794312


Contacts
Contact: Medical Director Medical Director 33473981436 p.pouliquen@laboratoires-thea.fr

Locations
France
Medical Director Recruiting
Clermont-Ferrand, France, 63000
Contact: Medical Director    33473981414      
Sponsors and Collaborators
Laboratoires Thea
  More Information

Responsible Party: Laboratoires Thea
ClinicalTrials.gov Identifier: NCT01794312     History of Changes
Other Study ID Numbers: LT4020-PIII-12/11
First Submitted: January 25, 2013
First Posted: February 18, 2013
Last Update Posted: November 10, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Ulcer
Keratitis
Corneal Ulcer
Pathologic Processes
Corneal Diseases
Eye Diseases
Eye Infections
Infection