CACICOL: Matrix Therapy And Bacterial Keratitis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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)
|
Outcome Measures
Primary Outcome Measures
- Epithelial corneal surface healing [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
Secondary Outcome Measures
- Healing time of total corneal epithelial wound [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 [at day 1 and day 12]
date of randomization and date of the complete corneal healing
- Ulcer deep [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 [at day 12]
at the end of the study
Eligibility Criteria
Criteria
Inclusion Criteria:
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- Hospitalized patients for bacterial keratitis in Ophthalmology Department, Clermont-Ferrand university hospital .with a controlled local infection after 48 hours local antibiotics.
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with a corneal ulcer diameter > 2 millimeters
Exclusion Criteria:
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- Ulcers deeper than the superficial stroma, perforated ulcers or pre-perforated, requiring a surgical intervention < 15 days.
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Clinical suspicion and/or microbiological evidence of fungal or parasitic infection
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Non controlled infection in spite of 48 hours intensive local antibiotics
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Allergy
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Silver or copper salts treatment
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Ocular surgery within the last 1 month
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Unable to follow up medical examinations for geographical, social, physical or psychological reasons
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Patient already included in another clinical trial
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Pregnant patients or breastfeeding
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Person under a legal protection measure, under guardianship
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Not cover by social insurance.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU de Clermont-Ferrand | Clermont-Ferrand | France | 63003 |
Sponsors and Collaborators
- University Hospital, Clermont-Ferrand
Investigators
- Principal Investigator: Frédéric CHIAMBARETTA, University Hospital, Clermont-Ferrand
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CHU-0169
- 2013-A01166-39