Matrix Therapy And Bacterial Keratitis

NCT02016989 | Unknown

• 2 other identifiers: CHU-01692013-A01166-39
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Keratitis

Keywords

Bacterial keratitis; OTR4120; Matrix therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Healing time of total corneal epithelial wound

  at day 1

• Visual acuity

  at day 1 and day 12

• Ulcer deep

  every day between day 0 to day 12

• Healing keratitis rate

  at day 12

Study Arms (2)

Physiological salt solution

OTHER

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.

Device: physiological salt solution

CACICOL20

EXPERIMENTAL

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.

Device: RGTA OTR4120 (CACICOL20)

Interventions

RGTA OTR4120 (CACICOL20) DEVICE

CACICOL20

physiological salt solution DEVICE

Physiological salt solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Study Officials

• Frédéric CHIAMBARETTA

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95; placarin@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: December 20, 2013
• Study Start: November 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: December 20, 2013

Record last verified: 2013-12

Locations

FR (1)