- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01242839
Randomized Double Blinded Study Evaluating CACICOL20 Efficiency Versus Placebo Corneal Chronic Ulcers Healing (UNICOL)
Randomized Multicentric Double Blinded Study Evaluating CACICOL20 Efficiency Versus Placebo Corneal Chronic Ulcers Healing
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Amiens, France, 80054
- Centre Hospitalier Universitaire Amiens
-
Angers, France, 49933
- CHU Angers
-
Bobigny, France, 93009
- Hopital Avicennes
-
Boulogne Billancourt, France, 92100
- Centre Hospitalier Ambroise Paré
-
Clermont Ferrand, France, 63003
- Hôpital Gabriel Montpied - CHU Clermont Ferrand
-
Dijon, France, 21079
- Centre Hospitalier Universitaire de Dijon
-
Le Kremlin-bicetre, France, 94275
- Hôpital Bicêtre
-
Lille, France, 59037
- CHRU Lille Hôpital Huriez
-
Limoges, France, 87042
- CHU Limoges, Hôpital Dupuytren
-
Lyon, France, 69003
- CHU LYON, Hôpital Edouard Herriot
-
Marseille, France, 13385
- AP-HM Hopital de la Timone
-
Nantes, France, 44093
- Centre Hospitalier Universitaire de Nantes
-
Paris, France, 75019
- Fondation Ophtalmologique Adolphe de Rothschild
-
Paris, France, 75181
- AP-HP Hôpital Hôtel-Dieu
-
Paris, France, 75571
- Centre Hospitalier des Quinze Vingt
-
Paris, France, 75877
- Hôpital Bichat - Claude-Bernard
-
Rouen, France, 76031
- CHU Hôpitaux de Rouen
-
Saint Jean d'Angély, France, 17415
- CH Saint Louis, Saint Jean d'Angély
-
Saint-Etienne, France, 42055
- Centre Hospitalier Universitaire de Saint-Etiennne
-
Strasbourg, France, 67091
- Hôpitaux Universitaires de Strasbourg
-
Tours, France, 37044
- Centre Hospitalier Universitaire de Tours
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CACICOL20
Arm that receives CACICOL20 treatment each 2 days for 3 months/until closure of the ulcer
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Healing rate
Time Frame: Within 1 months
|
The main judgment criteria is healing rate within 3 months defined as corneal ulcer complete closure.
|
Within 1 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Healing rate
Time Frame: 2 and 3 months
|
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
|
Visual pain scale
Time Frame: 1, 2 and 3 months
|
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
|
Associated treatments quotation
Time Frame: 1, 2 and 3 months
|
Quotation of analgesic treatments used and assessment of the effects of lubricant eye drops on the patient.
|
1, 2 and 3 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Christophe Baudouin, MD, XV- XX Hospital - Paris
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CT08L06UC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Corneal Ulcer
-
University of ArkansasTerminatedBacterial Corneal UlcerUnited States
-
Sight Medical Doctors PLLCDompé, US, Inc.RecruitingNeurotrophic Keratitis | Neurotrophic Ulcer | Neurotrophic Corneal Ulcer | Neurotrophic KeratoconjunctivitisUnited States
-
Aravind Eye Care SystemUnknownMycotic Corneal UlcerIndia
-
Minia UniversityCompleted
-
Alaa GamalAl-Azhar UniversityCompleted
-
TBF Genie TissulaireWithdrawnCorneal Ulcer | Persistent Corneal Epithelial Defect
-
Mahidol UniversityTerminated
-
Sohag UniversityRecruiting
-
Peschke GmbHRecruitingKeratitis | Corneal UlcerUnited States
Clinical Trials on CACICOL20
-
University Hospital, Clermont-FerrandUnknown
-
SynsLaser Kirurgi ASLaboratoires TheaUnknown
-
Neil LagaliLinkoeping University; Sahlgrenska University Hospital, Sweden; Region Östergötland and other collaboratorsTerminatedCorneal Dystrophy, Epithelial Basement Membrane | Epithelial Recurrent Erosion Dystrophy | Corneal ErosionsSweden
-
Forest LaboratoriesCompletedCystic Fibrosis | Pancreatic InsufficiencyUnited States
-
Medical University of ViennaCompleted
-
Plethora Solutions LtdCompleted
-
Plethora Solutions LtdShionogi Inc.CompletedPremature EjaculationUnited States