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NCT Number: NCT01242839

Randomized 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.

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Key information

Conditions

Corneal Ulcer Corneal Diseases Eye Diseases Eye Infections Infections Keratitis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire Amiens, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CACICOL20

Device

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

Device

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 outcomes

  1. Healing rate

    Time frame: Within 1 months

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

Secondary outcomes

  1. 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. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Organ, Tissue, Regeneration, Repair and Replacement

Industry

Collaborators

  • Assistance Publique - Hôpitaux de Paris

Registry information

Official study title

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

Acronym: UNICOL

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Nov 17, 2010
Registry last updated
May 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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