Randomized Double Blinded Study Evaluating CACICOL20 Efficiency Versus Placebo Corneal Chronic Ulcers Healing

Corneal Ulcer Clinical Trial

— UNICOL  

Official title:

Randomized Multicentric Double Blinded Study Evaluating CACICOL20 Efficiency Versus Placebo Corneal Chronic Ulcers Healing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01242839
• Other study ID #: CT08L06UC
• Status: Completed
• Phase: N/A
• First received: September 3, 2010
• Last updated: May 4, 2016
• Start date: April 2010
• Est. completion date: June 2014

Study information

• Verified date: May 2016
• Source: Organ, Tissue, Regeneration, Repair and Replacement
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: ANSM - French Medicines and Health Products Safety Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with non-infectious, corneal chronic ulcer, painful or not ,whose depth does not exceed the superficial stroma.

• Resistance of corneal pathology to standard treatment: eye drops to promote healing, tear substitutes, anti-inflammatory drugs, cyclosporin.

• Patients previously treated for the corneal pathology, assessed ineffective or Insufficiently effective by the investigator

• Patients using wetting gel or eye drops without conservator during the inclusion

• Anti-inflammatory local treatments must be stopped for at least 8 days.

• No contact lenses or lenses must be removed for at least 8 days.

• Age of inclusion = 18 years.

• Written and signed informed consent from patient.

• Realization of a preliminary medical examination.

• Covers by social insurance

Exclusion Criteria:

• Ulcers deeper than the superficial stroma, perforated ulcers or pre-perforated

• Corneal abscess

• Infectious and progressive ulcerative keratitis

• Patients receiving anti-inflammatory eye drops or steroid with cyclosporine treatment (in this case, possibility of inclusion in the clinical protocol after a Case "wash-out of 8 days)

• Patients on long-term eye drops containing preservatives and can not be stopped or replaced by an equivalent without preservatives

• Patients on systemic anti-inflammatory, anti-allergic, psychotropic or antibiotics therapies, modified since less than 10 days or likely to be on short-term

• Wearing contact lenses if patient has not been stopped at least eight days before the start of the protocol

• ocular surgery within the last 3 months

• patient already included in another clinical trial with an investigational product

• Pregnant patients or breastfeeding

• Person under a legal protection measure, under guardianship

• Unable to follow up medical examinations for geographical, social or psychological reasons

• Not cover by social insurance.

Study Design

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

Related Conditions & MeSH terms

• Corneal Ulcer
• Ulcer

Intervention

Device:
• CACICOL20
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.
• Placebo
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.

Locations

Country	Name	City	State
France	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-bicetre
France	CHRU Lille Hôpital Huriez	Lille
France	CHU Limoges, Hôpital Dupuytren	Limoges
France	CHU LYON, Hôpital Edouard Herriot	Lyon
France	AP-HM Hôpital de la Timone	Marseille
France	Centre Hospitalier Universitaire de Nantes	Nantes
France	AP-HP Hôpital Hôtel-Dieu	Paris
France	Centre Hospitalier des Quinze Vingt	Paris
France	Fondation Ophtalmologique Adolphe de Rothschild	Paris
France	Hôpital BICHAT - CLAUDE-BERNARD	Paris
France	CHU Hopitaux de Rouen	Rouen
France	CH Saint Louis, Saint Jean d'Angély	Saint Jean d'Angély
France	Centre Hospitalier Universitaire de Saint-Etiennne	Saint-Etienne
France	Hopitaux Universitaires de Strasbourg	Strasbourg
France	Centre Hospitalier Universitaire de Tours	Tours

Sponsors (2)

Lead Sponsor	Collaborator
Organ, Tissue, Regeneration, Repair and Replacement	Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing rate	The main judgment criteria is healing rate within 3 months defined as corneal ulcer complete closure.	Within 1 months	No
Secondary	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.	2 and 3 months	No
Secondary	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.	1, 2 and 3 months	No
Secondary	Associated treatments quotation	Quotation of analgesic treatments used and assessment of the effects of lubricant eye drops on the patient.	1, 2 and 3 months	No