Clinical Trial: Matrix Therapy And Bacterial Keratitis

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: REGENERATING AGENT (OTR4120) AND BACTERIAL KERATITIS : A RANDOMISED TRIAL

Brief Summary: The purpose of this study is to evaluate efficiency of CACICOL20 for bacterial keratitis. It is a double blinded comparison of epithelial defect in two groups of patients randomized between CACICOL20 and physiological salt solution.

Detailed Summary:

Extracellular matrix, composed of glycosaminoglycans (GAG) and matricial proteins, has a key role in tissular homeostasis.

The matrix therapy is a new class of medical substance, called RGTAs, ReGeneraTing Agents, consist of chemically engineered polymers adapted to interact with and protect against proteolytic degradation of cytokines.

OTR4120 (CACICOL20) is an heparan sulphate (HS) mimetic that can replace the degraded HS and protect and improve the bioavailability of cytokines. It aims to facilitate and potentiate the wound healing by restorating the natural microenvironment.

CACICOL20 was used in treating corneal dystrophies and chronic corneal ulcers. It significantly favored corneal healing. It was well tolerated with no side effects.

Bacterial keratitis is a serious ocular condition that may result in significant sight-threatening corneal sequelae. The common risk factors for infectious keratitis include ocular trauma, contact lens wear, recent ocular surgery, preexisting ocular surface disease, dry eyes, lid deformity, corneal sensational impairment, chronic use of topical steroids, and systemic immunosuppression. Serious cases of keratitis are hospitalized to administrate an intensive hospital-made local antibiotic.

The purpose of this study is to evaluate efficiency of CACICOL20 for bacterial keratitis. It is a double blinded comparison of epithelial defect in two groups of patients randomized between CACICOL20 and physiological salt solution.


Sponsor: University Hospital, Clermont-Ferrand

Current Primary Outcome: Epithelial corneal surface healing [ Time Frame: at day 1 ]

each day, from date of randomization until the date of the complete corneal healing assessed to fifteen days, up to 2 months


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Healing time of total corneal epithelial wound [ Time Frame: at day 1 ]
    each day, from date of randomization until the date of the complete corneal healing assessed to fifteen days, up to 2 months
  • Visual acuity [ Time Frame: at day 1 and day 12 ]
    date of randomization and date of the complete corneal healing
  • Ulcer deep [ Time Frame: every day between day 0 to day 12 ]
    every two days, from date of randomization until the date of the complete corneal healing assessed to fifteen days, up to 2 months
  • Healing keratitis rate [ Time Frame: at day 12 ]
    at the end of the study


Original Secondary Outcome: Same as current

Information By: University Hospital, Clermont-Ferrand

Dates:
Date Received: November 25, 2013
Date Started: November 2013
Date Completion: October 2014
Last Updated: December 16, 2013
Last Verified: December 2013