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

Primary Purpose

Corneal Ulcer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CACICOL20
Placebo
Sponsored by
Organ, Tissue, Regeneration, Repair and Replacement
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corneal Ulcer focused on measuring CACICOL20

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Hospitalier Universitaire Amiens
  • CHU Angers
  • Hopital Avicennes
  • Centre Hospitalier Ambroise Paré
  • Hôpital Gabriel Montpied - CHU Clermont Ferrand
  • Centre Hospitalier Universitaire de Dijon
  • Hôpital BICETRE
  • CHRU Lille Hôpital Huriez
  • CHU Limoges, Hôpital Dupuytren
  • CHU LYON, Hôpital Edouard Herriot
  • AP-HM Hôpital de la Timone
  • Centre Hospitalier Universitaire de Nantes
  • Fondation Ophtalmologique Adolphe de Rothschild
  • AP-HP Hôpital Hôtel-Dieu
  • Centre Hospitalier des Quinze Vingt
  • Hôpital BICHAT - CLAUDE-BERNARD
  • CHU Hopitaux de Rouen
  • CH Saint Louis, Saint Jean d'Angély
  • Centre Hospitalier Universitaire de Saint-Etiennne
  • Hopitaux Universitaires de Strasbourg
  • Centre Hospitalier Universitaire de Tours

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

CACICOL20

Placebo

CACICOL20 and Placebo

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Healing rate
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
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
Quotation of analgesic treatments used and assessment of the effects of lubricant eye drops on the patient.

Full Information

First Posted
September 3, 2010
Last Updated
May 4, 2016
Sponsor
Organ, Tissue, Regeneration, Repair and Replacement
Collaborators
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01242839
Brief Title
Randomized Double Blinded Study Evaluating CACICOL20 Efficiency Versus Placebo Corneal Chronic Ulcers Healing
Acronym
UNICOL
Official Title
Randomized Multicentric Double Blinded Study Evaluating CACICOL20 Efficiency Versus Placebo Corneal Chronic Ulcers Healing
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organ, Tissue, Regeneration, Repair and Replacement
Collaborators
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Ulcer
Keywords
CACICOL20

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CACICOL20
Arm Type
Experimental
Arm Description
Arm that receives CACICOL20 treatment each 2 days for 3 months/until closure of the ulcer
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo is applicated each 2 days on patient cornea for 3 months/ until ulcer closure.
Arm Title
CACICOL20 and Placebo
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
CACICOL20
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Healing rate
Description
The main judgment criteria is healing rate within 3 months defined as corneal ulcer complete closure.
Time Frame
Within 1 months
Secondary Outcome Measure Information:
Title
Healing rate
Description
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.
Time Frame
2 and 3 months
Title
Visual pain scale
Description
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.
Time Frame
1, 2 and 3 months
Title
Associated treatments quotation
Description
Quotation of analgesic treatments used and assessment of the effects of lubricant eye drops on the patient.
Time Frame
1, 2 and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Baudouin, MD
Organizational Affiliation
XV- XX Hospital - Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Hopital Avicennes
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
Centre Hospitalier Ambroise Paré
City
Boulogne Billancourt
ZIP/Postal Code
92100
Country
France
Facility Name
Hôpital Gabriel Montpied - CHU Clermont Ferrand
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Centre Hospitalier Universitaire de Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Hôpital BICETRE
City
Le Kremlin-bicetre
ZIP/Postal Code
94275
Country
France
Facility Name
CHRU Lille Hôpital Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Limoges, Hôpital Dupuytren
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
CHU LYON, Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
AP-HM Hôpital de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Centre Hospitalier Universitaire de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Fondation Ophtalmologique Adolphe de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
AP-HP Hôpital Hôtel-Dieu
City
Paris
ZIP/Postal Code
75181
Country
France
Facility Name
Centre Hospitalier des Quinze Vingt
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
Hôpital BICHAT - CLAUDE-BERNARD
City
Paris
ZIP/Postal Code
75877
Country
France
Facility Name
CHU Hopitaux de Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
CH Saint Louis, Saint Jean d'Angély
City
Saint Jean d'Angély
ZIP/Postal Code
17415
Country
France
Facility Name
Centre Hospitalier Universitaire de Saint-Etiennne
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
Hopitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Centre Hospitalier Universitaire de Tours
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

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

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