Matrix Therapy And Bacterial Keratitis (CACICOL)

University Hospital, Clermont-Ferrand

Status: Unknown

Conditions: Bacterial Keratitis

Treatments: Device: RGTA OTR4120 (CACICOL20); Device: physiological salt solution

Study type: Interventional

Funder types: Other

Identifiers

NCT02016989

2013-A01166-39

CHU-0169

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Physiological salt solution

Other group

Description:

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.

Treatment:

Device: physiological salt solution

CACICOL20

Experimental group

Description:

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.

Treatment:

Device: RGTA OTR4120 (CACICOL20)