Informations générales (source: ClinicalTrials.gov)
REGENERATING AGENT (OTR4120) AND BACTERIAL KERATITIS : A RANDOMISED TRIAL (CACICOL)
Interventional
N/A
University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)
novembre 2013
octobre 2014
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU de Clermont-Ferrand - 63003 - Clermont-Ferrand - France | Patrick LACARIN | Contact (sur clinicalTrials) | |||
Critères
Tous
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
-
- 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
-
- 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.