Bacterial Keratitis
Conditions
Keywords
Bacterial keratitis, OTR4120, Matrix therapy
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.
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.
Interventions
DEVICERGTA OTR4120 (CACICOL20)
DEVICEphysiological salt solution
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Contacts
Primary ContactPatrick LACARIN
Outcome results
None listed