Bacterial Keratitis Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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