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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
CHU de Clermont-Ferrand
Clermont-Ferrand, France
RECRUITINGEpithelial 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
Time frame: at day 1
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
Time frame: at day 1
Visual acuity
date of randomization and date of the complete corneal healing
Time frame: 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
Time frame: every day between day 0 to day 12
Healing keratitis rate
at the end of the study
Time frame: at day 12
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