Matrix Therapy And Bacterial Keratitis (CACICOL)

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

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.

Study Overview

• Status: Unknown
• Conditions: Bacterial Keratitis
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Recruiting
    • CHU de Clermont-Ferrand
    • Sub-Investigator: Nicolas BONNIN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epithelial corneal surface healing	each day, from date of randomization until the date of the complete corneal healing assessed to fifteen days, up to 2 months	at day 1

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Frederic CHIAMBARETTA, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): September 1, 2014
• Study Completion (Anticipated): October 1, 2014

Study Registration Dates

• First Submitted: November 25, 2013
• First Submitted That Met QC Criteria: December 16, 2013
• First Posted (Estimate): December 20, 2013

Study Record Updates

• Last Update Posted (Estimate): December 20, 2013
• Last Update Submitted That Met QC Criteria: December 16, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Bacterial keratitis; OTR4120; Matrix therapy
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratitis
• Other Study ID Numbers: CHU-0169; 2013-A01166-39