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

NCT01242839 | Completed

• 1 other identifier: CT08L06UC
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 21

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

Keywords

CACICOL20

Outcome Measures

Primary Outcomes (1)

• Healing rate

  The main judgment criteria is healing rate within 3 months defined as corneal ulcer complete closure.

  Within 1 months

Secondary Outcomes (3)

• Healing rate

  2 and 3 months

• Visual pain scale

  1, 2 and 3 months

• Associated treatments quotation

  1, 2 and 3 months

Study Arms (3)

CACICOL20

EXPERIMENTAL

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

Device: CACICOL20

Placebo

PLACEBO COMPARATOR

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

Device: Placebo

CACICOL20 and Placebo

EXPERIMENTAL

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.

Device: CACICOL20

Interventions

CACICOL20 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.

CACICOL20; CACICOL20 and Placebo

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• Written and signed informed consent from patient.
• Realization of a preliminary medical examination.
• Covers by social insurance

You may not qualify if:

• Ulcers deeper than the superficial stroma, perforated ulcers or pre-perforated
• Corneal abscess
• Infectious and progressive ulcerative keratitis
• 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.

Sponsors & Collaborators

• Organ, Tissue, Regeneration, Repair and Replacement: lead
• Assistance Publique - Hôpitaux de Paris: collaborator

Study Sites (21)

Centre Hospitalier Universitaire Amiens

Amiens, 80054, France

Location

CHU Angers

Angers, 49933, France

Location

Hopital Avicennes

Bobigny, 93009, France

Location

Centre Hospitalier Ambroise Paré

Boulogne-Billancourt, 92100, France

Location

Hôpital Gabriel Montpied - CHU Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

Centre Hospitalier Universitaire de Dijon

Dijon, 21079, France

Location

Hôpital BICETRE

Le Kremlin-Bicêtre, 94275, France

Location

CHRU Lille Hôpital Huriez

Lille, 59037, France

Location

CHU Limoges, Hôpital Dupuytren

Limoges, 87042, France

Location

CHU LYON, Hôpital Edouard Herriot

Lyon, 69003, France

Location

AP-HM Hôpital de la Timone

Marseille, 13385, France

Location

Centre Hospitalier Universitaire de Nantes

Nantes, 44093, France

Location

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

AP-HP Hôpital Hôtel-Dieu

Paris, 75181, France

Location

Centre Hospitalier des Quinze Vingt

Paris, 75571, France

Location

Hôpital BICHAT - CLAUDE-BERNARD

Paris, 75877, France

Location

CHU Hopitaux de Rouen

Rouen, 76031, France

Location

Centre Hospitalier Universitaire de Saint-Etiennne

Saint-Etienne, 42055, France

Location

CH Saint Louis, Saint Jean d'Angély

Saint-Jean-d'Angély, 17415, France

Location

Hopitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Centre Hospitalier Universitaire de Tours

Tours, 37044, France

Location

MeSH Terms

Conditions

Corneal Ulcer

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Keratitis; Corneal Diseases; Eye Diseases

Study Officials

• Christophe Baudouin, MD

  XV- XX Hospital - Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2010
• First Posted: November 17, 2010
• Study Start: April 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: May 5, 2016

Record last verified: 2016-05

Locations

FR (21)