CACICOL20 is a biodegradable nanopolymer engineered to mimic glycosaminoglycans such as heparan sulfates. Applied to the corneal lesion, it replaces damaged heparan sulfates in the matrix scaffold. CACICOL20 binds to matrix proteins such as collagen and cytokines or endogenous growth factors of the cellular microenvironment. CACICOL20 provides a protective function and restores the matrix architecture. This produces a suitable spatial environment for cells to respond properly to the cascade of signals needed for tissue regeneration to resume. The ophthalmic solution, CACICOL20, used for corneal ulcers is very well tolerated both locally and generally, as proved by a pilot study which as been conducted at the "Hôpital des XV-XX" in Paris (France). It reduces the pain significantly and increases corneal ulcer healing (all ulcers treated were resistant to all other usual therapies). Therefore, the accuracy of a Randomized multicentric double blinded study to evaluate the efficacy of CACICOL20 versus placebo for chronic corneal ulcer healing has been shown and will begin mid-may 2010. In this study, CACICOL20 will be applied every 2 or 4 days for 3 months. The aim of the study is a double blinded comparison of complete chronic corneal ulcers healing rate within 3 months in 3 groups of patient double blinded randomized between CACICOL20 instillations distribution and physiological salt solution instillations distribution. The main judgment criteria is healing rate within 3 months defined as corneal ulcer complete closure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
139
CACICOL20 is a solution of dextran \& poly(carboxymethylglucose sulphate)in physiological salt serum. CACICOL20 is presented in 0.33 mL strip. One drop is instilled at each application to impregnate cornea.
It is the placebo of CACICOL20, containing dextran in physiological serum salt. It is presented, like CACICOL20, in a 0.33 mL strip. One drop is delivered at each application.
Centre Hospitalier Universitaire Amiens
Amiens, France
CHU Angers
Angers, France
Hopital Avicennes
Bobigny, France
Centre Hospitalier Ambroise Paré
Boulogne-Billancourt, France
Hôpital Gabriel Montpied - CHU Clermont Ferrand
Clermont-Ferrand, France
Centre Hospitalier Universitaire de Dijon
Dijon, France
Hôpital BICETRE
Le Kremlin-Bicêtre, France
CHRU Lille Hôpital Huriez
Lille, France
CHU Limoges, Hôpital Dupuytren
Limoges, France
CHU LYON, Hôpital Edouard Herriot
Lyon, France
...and 11 more locations
Healing rate
The main judgment criteria is healing rate within 3 months defined as corneal ulcer complete closure.
Time frame: Within 1 months
Healing rate
Complete Healing rate of the ulcer at 1 and 2 months defined as corneal ulcer complete closure, the evaluation of the pain with visual pain scale and evaluation of the quotation of analgesic treatments used by the patient.
Time frame: 2 and 3 months
Visual pain scale
Complete Healing rate of the ulcer at 1 and 2 months defined as corneal ulcer complete closure, the evaluation of the pain with visual pain scale and evaluation of the quotation of analgesic treatments used by the patient.
Time frame: 1, 2 and 3 months
Associated treatments quotation
Quotation of analgesic treatments used and assessment of the effects of lubricant eye drops on the patient.
Time frame: 1, 2 and 3 months
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