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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Organ, Tissue, Regeneration, Repair and Replacement
Sponsor:
Collaborator:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Organ, Tissue, Regeneration, Repair and Replacement
ClinicalTrials.gov Identifier:
NCT01242839
First received: September 3, 2010
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Corneal Ulcer
Device: CACICOL20
Device: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Multicentric Double Blinded Study Evaluating CACICOL20 Efficiency Versus Placebo Corneal Chronic Ulcers Healing

Resource links provided by NLM:


Further study details as provided by Organ, Tissue, Regeneration, Repair and Replacement:

Primary Outcome Measures:
  • Healing rate [ Time Frame: Within 1 months ] [ Designated as safety issue: No ]
    The main judgment criteria is healing rate within 3 months defined as corneal ulcer complete closure.


Secondary Outcome Measures:
  • Healing rate [ Time Frame: 2 and 3 months ] [ Designated as safety issue: No ]
    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.

  • Visual pain scale [ Time Frame: 1, 2 and 3 months ] [ Designated as safety issue: No ]
    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.

  • Associated treatments quotation [ Time Frame: 1, 2 and 3 months ] [ Designated as safety issue: No ]
    Quotation of analgesic treatments used and assessment of the effects of lubricant eye drops on the patient.


Estimated Enrollment: 128
Study Start Date: April 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CACICOL20
Arm that receives CACICOL20 treatment each 2 days for 3 months/until closure of the ulcer
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 Comparator: Placebo
The placebo is applicated each 2 days on patient cornea for 3 months/ until ulcer closure.
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.
Experimental: 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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01242839

Contacts
Contact: Ketty Kichenin, PhD +33663353239 ketty.kichenin@otr3.com
Contact: Ketty Kichenin, PhD +33183638544 ketty.kichenin@otr3.com

Locations
France
Centre Hospitalier Universitaire Amiens Recruiting
Amiens, France, 80054
Contact: Dominique Bremond-Gignac, MD/Pr    +33322824108    bremond.dominique@chu-amiens.fr   
Principal Investigator: Dominique Bremond-Gignac, MD/Pr         
CHU Angers Recruiting
Angers, France, 49933
Contact: Philippe GOHIER    33241353274    phgohier@chu-angers.fr   
Contact: Ghislaine JALLET       ghjallet@chu-angers.fr   
Principal Investigator: Philippe GOHIER, MD         
Sub-Investigator: Ghislaine JALLET, MD         
Hopital Avicennes Recruiting
Bobigny, France, 93009
Contact: Gilles Chaine, MD/Pr    33148955555    gilles.chaine@ave.aphp.fr   
Sub-Investigator: Franck Fajnkuchen, MD         
Principal Investigator: Gilles Chaine, MD/Pr         
Sub-Investigator: Typhaine Grenet, MD         
Centre Hospitalier Ambroise Paré Recruiting
Boulogne Billancourt, France, 92100
Contact: Christophe Baudouin, MD/Pr    33149095509      
Principal Investigator: Christophe Baudouin, MD/Pr         
Hôpital Gabriel Montpied - CHU Clermont Ferrand Recruiting
Clermont Ferrand, France, 63003
Contact: Louise Marie Coulangeon    +33473751467    icoulangeon@chu-clermontferrand.fr   
Principal Investigator: Fréderic CHIAMBARETTA, MD         
Sub-Investigator: Antoine VIENNET, MD         
Centre Hospitalier Universitaire de Dijon Recruiting
Dijon, France, 21079
Contact: Catherine Creuzot-Garcher, MD/Pr    33380293756    catherine.creuzot-garcher@chu-dijon.fr   
Principal Investigator: Catherine Creuzot-Garcher, MD/Pr         
Hôpital BICETRE Recruiting
Le Kremlin-bicetre, France, 94275
Contact: Marc LABETOULLE, MD    +33145212837    marc.labetoulle@bct.ap-hop-paris.fr   
Principal Investigator: Marc LABETOULLE, MD         
CHRU Lille Hôpital Huriez Recruiting
Lille, France, 59037
Contact: Jean-François Rouland    33320445354    jfrouland@chru-lille.fr   
Principal Investigator: Jean-François Rouland, MD/Pr         
CHU Limoges, Hôpital Dupuytren Recruiting
Limoges, France, 87042
Contact: Pierre-Yves Robert    33555056255    pierre-yves.robert@unilim.fr   
Principal Investigator: Pierre-Yves Robert, MD/Pr         
CHU LYON, Hôpital Edouard Herriot Recruiting
Lyon, France, 69003
Contact: Carole BURILLON    33472116238    carole.burillon@chu-lyon.fr   
Principal Investigator: Carole BURILLON, MD/Pr         
AP-HM Hôpital de la Timone Recruiting
Marseille, France, 13385
Contact: Louis Hoffart    33491386437    louis.hoffart@ap-hm.fr   
Principal Investigator: Louis Hoffart, MD         
Centre Hospitalier Universitaire de Nantes Recruiting
Nantes, France, 44093
Contact: Michel Weber    33240083656    michel.weber@chu-nantes.fr   
Principal Investigator: Michel Weber, MD/Pr         
AP-HP Hôpital Hôtel-Dieu Recruiting
Paris, France, 75181
Contact: Jean-Louis Bourges, MD/Pr    33142348234    Jean-louis.bourges@htd.aphp.fr   
Principal Investigator: Jean-Louis Bourges, MD/Pr         
Centre Hospitalier des Quinze Vingt Recruiting
Paris, France, 75571
Contact: Christophe Baudouin, MD/Pr    33140021520    baudouin@quinze-vingt.fr   
Principal Investigator: Christophe Baudouin, MD/Pr         
Fondation Ophtalmologique Adolphe de Rothschild Recruiting
Paris, France, 75019
Contact: Isabelle Cochereau, MD    +33148036486    icochereau@fo-rothschild.fr   
Contact: Eric GABISON, MD    +33148036486    egabison@free.fr   
Sub-Investigator: Eric GABISON, MD         
Principal Investigator: Isabelle COCHEREAU, MD         
Hôpital BICHAT - CLAUDE-BERNARD Recruiting
Paris, France, 75877
Contact: Serge DOAN, M.D    +33140258441    serge.doan@bch.aphp.fr   
Principal Investigator: Isabelle COCHEREAU, MD         
Sub-Investigator: Serge DOAN, MD         
CHU Hopitaux de Rouen Recruiting
Rouen, France, 76031
Contact: Marc Muraine, MD/Pr    33232888057    marc.muraine@univ-rouen.fr   
Principal Investigator: Marc Muraine, MD/Pr         
CH Saint Louis, Saint Jean d'Angély Recruiting
Saint Jean d'Angély, France, 17415
Contact: Jean‐Jacques GICQUEL    33546595029    gicquelophtha@aol.com   
Principal Investigator: Jean‐Jacques GICQUEL, MD         
Centre Hospitalier Universitaire de Saint-Etiennne Recruiting
Saint-Etienne, France, 42055
Contact: Philippe Gain    33477127793    philippe.gain@univ-st-etienne.fr   
Principal Investigator: Philippe Gain, MD/Pr         
Hopitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67091
Contact: Tristan Bourcier, MD/Pr    33388116138    tristan.bourcier@chru.strasbourg.fr   
Principal Investigator: Tristan Bourcier, MD/Pr         
Centre Hospitalier Universitaire de Tours Recruiting
Tours, France, 37044
Contact: Pierre-Jean Pisella, MD/Pr    33247478766    pj.pisella@chu-tours.fr   
Principal Investigator: Pierre-Jean Pisella, MD/Pr         
Sponsors and Collaborators
Organ, Tissue, Regeneration, Repair and Replacement
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Christophe Baudouin, MD XV- XX Hospital - Paris
  More Information

No publications provided

Responsible Party: Organ, Tissue, Regeneration, Repair and Replacement
ClinicalTrials.gov Identifier: NCT01242839     History of Changes
Other Study ID Numbers: CT08L06UC
Study First Received: September 3, 2010
Last Updated: April 8, 2014
Health Authority: France: ANSM - French Medicines and Health Products Safety Agency

Keywords provided by Organ, Tissue, Regeneration, Repair and Replacement:
CACICOL20

Additional relevant MeSH terms:
Corneal Ulcer
Ulcer
Eye Infections
Infection
Keratitis
Corneal Diseases
Eye Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014