Matrix Therapy And Bacterial Keratitis

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Bacterial Keratitis

Intervention / Treatment
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* Device: RGTA OTR4120 (CACICOL20)
* Device: physiological salt solution


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Physiological salt solution<br>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<br> <br> |
| Experimental: CACICOL20<br>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)<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bacterial keratitis, OTR4120, Matrix therapy