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

NCT ID: NCT01242839

Last Updated: 2016-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2014-06-30

Brief 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.

Conditions

Corneal Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CACICOL20

Arm that receives CACICOL20 treatment each 2 days for 3 months/until closure of the ulcer

Group Type: EXPERIMENTAL

CACICOL20

Intervention Type: DEVICE

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

The placebo is applicated each 2 days on patient cornea for 3 months/ until ulcer closure.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DEVICE

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.

CACICOL20 and Placebo

Patient applies the treatment each 2 days for 3 months or until closure of the ulcer. This treatment is alternatively CACICOL20 or Placebo : so the patient receives CACICOL20 each 4 days. CACICOL20 and placebo strips are strictly similar and cannot be identified.

Group Type: EXPERIMENTAL

CACICOL20

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: collaborator

Organ, Tissue, Regeneration, Repair and Replacement

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christophe Baudouin, MD

Role: PRINCIPAL_INVESTIGATOR

XV- XX Hospital - Paris

Locations

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

AP-HM Hôpital de la Timone

Marseille, , France

Centre Hospitalier Universitaire de Nantes

Nantes, , France

Fondation Ophtalmologique Adolphe de Rothschild

Paris, , France

AP-HP Hôpital Hôtel-Dieu

Paris, , France

Centre Hospitalier des Quinze Vingt

Paris, , France

Hôpital BICHAT - CLAUDE-BERNARD

Paris, , France

CHU Hopitaux de Rouen

Rouen, , France

Centre Hospitalier Universitaire de Saint-Etiennne

Saint-Etienne, , France

CH Saint Louis, Saint Jean d'Angély

Saint-Jean-d'Angély, , France

Hopitaux Universitaires de Strasbourg

Strasbourg, , France

Centre Hospitalier Universitaire de Tours

Tours, , France

Countries

France

Other Identifiers

CT08L06UC

Identifier Type: -

Identifier Source: org_study_id