Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2013-11-30
2014-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
physiological salt solution
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.
RGTA OTR4120 (CACICOL20)
Interventions
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RGTA OTR4120 (CACICOL20)
physiological salt solution
Eligibility Criteria
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Inclusion Criteria
* with a corneal ulcer diameter \> 2 millimeters
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Frédéric CHIAMBARETTA
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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CHU de Clermont-Ferrand
Clermont-Ferrand, , France
Countries
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Central Contacts
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Facility Contacts
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Patrick LACARIN
Role: primary
Other Identifiers
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2013-A01166-39
Identifier Type: -
Identifier Source: secondary_id
CHU-0169
Identifier Type: -
Identifier Source: org_study_id