Matrix Therapy And Bacterial Keratitis (CACICOL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University Hospital, Clermont-Ferrand
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT02016989
First received: November 25, 2013
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Bacterial Keratitis
Device: RGTA OTR4120 (CACICOL20)
Device: physiological salt solution

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: REGENERATING AGENT (OTR4120) AND BACTERIAL KERATITIS : A RANDOMISED TRIAL

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Epithelial corneal surface healing [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]
    each day, from date of randomization until the date of the complete corneal healing assessed to fifteen days, up to 2 months


Secondary Outcome Measures:
  • Healing time of total corneal epithelial wound [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    date of randomization and date of the complete corneal healing

  • Ulcer deep [ Time Frame: every day between day 0 to day 12 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    at the end of the study


Estimated Enrollment: 60
Study Start Date: November 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Physiological salt solution
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.
Device: physiological salt solution
Experimental: CACICOL20
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.
Device: RGTA OTR4120 (CACICOL20)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • - Hospitalized patients for bacterial keratitis in Ophthalmology Department, Clermont-Ferrand university hospital .with a controlled local infection after 48 hours local antibiotics.

    • with a corneal ulcer diameter > 2 millimeters

Exclusion Criteria:

  • - Ulcers deeper than the superficial stroma, perforated ulcers or pre-perforated, requiring a surgical intervention < 15 days.
  • Clinical suspicion and/or microbiological evidence of fungal or parasitic infection
  • Non controlled infection in spite of 48 hours intensive local antibiotics
  • Allergy
  • Silver or copper salts treatment
  • Ocular surgery within the last 1 month
  • Unable to follow up medical examinations for geographical, social, physical or psychological reasons
  • Patient already included in another clinical trial
  • Pregnant patients or breastfeeding
  • Person under a legal protection measure, under guardianship
  • Not cover by social insurance.
  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: NCT02016989

Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sub-Investigator: Nicolas BONNIN         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Frédéric CHIAMBARETTA University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02016989     History of Changes
Other Study ID Numbers: CHU-0169, 2013-A01166-39
Study First Received: November 25, 2013
Last Updated: December 16, 2013
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Bacterial keratitis
OTR4120
Matrix therapy

Additional relevant MeSH terms:
Keratitis
Corneal Diseases
Eye Diseases
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014