Randomized Double Blinded Study Evaluating CACICOL20 Efficiency Versus Placebo Corneal Chronic Ulcers Healing (UNICOL)
This study is currently recruiting participants.
Verified April 2013 by Organ, Tissue, Regeneration, Repair and Replacement
Sponsor:
Organ, Tissue, Regeneration, Repair and Replacement
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 30, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: | September 2013 |
| Primary Completion Date: | June 2010 (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
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 30, 2013 |
| 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 May 22, 2013