Clinical trial NCT02016989: Matrix Therapy And Bacterial Keratitis
Official title: REGENERATING AGENT (OTR4120) AND BACTERIAL KERATITIS : A RANDOMISED TRIAL
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bacterial Keratitis
Keywords: Bacterial keratitis
OTR4120
Matrix therapy
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2013-12-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Epithelial corneal surface healing
timeFrame: at day 1
Secondary outcomes:
measure: Healing time of total corneal epithelial wound
timeFrame: at day 1
measure: Visual acuity
timeFrame: at day 1 and day 12
measure: Ulcer deep
timeFrame: every day between day 0 to day 12
measure: Healing keratitis rate
timeFrame: at day 12
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Frédéric CHIAMBARETTA
role: PRINCIPAL_INVESTIGATOR
References: