Status:
COMPLETED
Randomized Double Blinded Study Evaluating CACICOL20 Efficiency Versus Placebo Corneal Chronic Ulcers Healing
Lead Sponsor:
Organ, Tissue, Regeneration, Repair and Replacement
Collaborating Sponsors:
Assistance Publique - Hôpitaux de Paris
Conditions:
Corneal Ulcer
Eligibility:
All Genders
18-75 years
Phase:
NA
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. CA...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT01242839
Start Date
April 1 2010
End Date
June 1 2014
Last Update
May 5 2016
Active Locations (21)
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1
Centre Hospitalier Universitaire Amiens
Amiens, France, 80054
2
CHU Angers
Angers, France, 49933
3
Hopital Avicennes
Bobigny, France, 93009
4
Centre Hospitalier Ambroise Paré
Boulogne-Billancourt, France, 92100