Matrix Therapy And Bacterial Keratitis

Bacterial Keratitis Clinical Trial

— CACICOL  

Official title:

REGENERATING AGENT (OTR4120) AND BACTERIAL KERATITIS : A RANDOMISED TRIAL

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02016989
• Other study ID #: CHU-0169
• Secondary ID: 2013-A01166-39
• Status: Recruiting
• Phase: N/A
• First received: November 25, 2013
• Last updated: December 16, 2013
• Start date: November 2013
• Est. completion date: October 2014

Study information

• Verified date: December 2013
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Keratitis
• Keratitis

Intervention

Device:
• RGTA OTR4120 (CACICOL20)

• physiological salt solution

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epithelial 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	at day 1	Yes
Secondary	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	at day 1	Yes
Secondary	Visual acuity	date of randomization and date of the complete corneal healing	at day 1 and day 12	Yes
Secondary	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	every day between day 0 to day 12	Yes
Secondary	Healing keratitis rate	at the end of the study	at day 12	Yes