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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Laboratoires Thea
Sponsor:
Information provided by (Responsible Party):
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT01794312
First received: January 25, 2013
Last updated: October 8, 2014
Last verified: January 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Best corrected visual acuity [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 124
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Laboratoires Thea
ClinicalTrials.gov Identifier: NCT01794312     History of Changes
Other Study ID Numbers: LT4020-PIII-12/11
Study First Received: January 25, 2013
Last Updated: October 8, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

ClinicalTrials.gov processed this record on October 20, 2014