Corneal UlcerUNICOLNCT01242839
Randomized Double Blinded Study Evaluating CACICOL20 Efficiency Versus Placebo Corneal Chronic Ulcers Healing
A study testing CACICOL20 in people with Corneal Ulcer, run by Organ, Tissue, Regeneration, Repair and Replacement at 21 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Corneal Ulcer
- What is being tested?
- CACICOL20
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 139 participants
- Where
- 21 sitesFrance
- Study dates
- Apr 2010to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Age of inclusion ≥ 18 years.
- Written and signed informed consent from patient.
- Realization of a preliminary medical examination.
- Covers by social insurance
Who cannot join
- 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
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- 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.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
France21 sites
Centre Hospitalier Universitaire Amiens
Amiens, 80054
CHU Angers
Angers, 49933
Hopital Avicennes
Bobigny, 93009
Centre Hospitalier Ambroise Paré
Boulogne-Billancourt, 92100
Hôpital Gabriel Montpied - CHU Clermont Ferrand
Clermont-Ferrand, 63003
Centre Hospitalier Universitaire de Dijon
Dijon, 21079
Hôpital BICETRE
Le Kremlin-Bicêtre, 94275
CHRU Lille Hôpital Huriez
Lille, 59037
CHU Limoges, Hôpital Dupuytren
Limoges, 87042
CHU LYON, Hôpital Edouard Herriot
Lyon, 69003
AP-HM Hôpital de la Timone
Marseille, 13385
Centre Hospitalier Universitaire de Nantes
Nantes, 44093
Fondation Ophtalmologique Adolphe de Rothschild
Paris, 75019
AP-HP Hôpital Hôtel-Dieu
Paris, 75181
Centre Hospitalier des Quinze Vingt
Paris, 75571
Hôpital BICHAT - CLAUDE-BERNARD
Paris, 75877
CHU Hopitaux de Rouen
Rouen, 76031
Centre Hospitalier Universitaire de Saint-Etiennne
Saint-Etienne, 42055
CH Saint Louis, Saint Jean d'Angély
Saint-Jean-d'Angély, 17415
Hopitaux Universitaires de Strasbourg
Strasbourg, 67091
Centre Hospitalier Universitaire de Tours
Tours, 37044
About this study
Official title: 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).
Read more
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.
- Conditions
- Corneal Ulcer
- Being tested
- CACICOL20, Placebo
- Keywords
- CACICOL20
- Medical subject headings
- Corneal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CACICOL20Device
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.
PlaceboDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CACICOL20 | Experimental | Arm that receives CACICOL20 treatment each 2 days for 3 months/until closure of the ulcer Receives: Device: CACICOL20 |
| Placebo | Placebo comparator | The placebo is applicated each 2 days on patient cornea for 3 months/ until ulcer closure. Receives: Device: Placebo |
| CACICOL20 and Placebo | Experimental | 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. Receives: Device: CACICOL20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing rate
The main judgment criteria is healing rate within 3 months defined as corneal ulcer complete closure.
Measured: Within 1 months
Secondary outcomes (3)
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.
Measured: 2 and 3 months
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.
Measured: 1, 2 and 3 months
Associated treatments quotation
Quotation of analgesic treatments used and assessment of the effects of lubricant eye drops on the patient.
Measured: 1, 2 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organ, Tissue, Regeneration, Repair and Replacement
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Responsible party
- Sponsor
- Investigators
- Christophe Baudouin, MD, Principal investigator, XV- XX Hospital - Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242839
- Sponsor's protocol ID
- CT08L06UC
- Acronym
- UNICOL
- Status last verified
- May 2016
- First submitted
- 3 Sep 2010
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multicentric Double Blinded Study Evaluating CACICOL20 Efficiency Versus Placebo Corneal Chronic Ulcers Healing
- ClinicalTrials.gov ID
- NCT01242839
- Acronym / sponsor ID
- UNICOL / CT08L06UC
- Conditions
- Corneal Ulcer
- Keywords
- CACICOL20
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Organ, Tissue, Regeneration, Repair and ReplacementIndustry (pharma, biotech, devices)
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Study start
- Apr 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 17 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CACICOL20 | Experimental | Device: CACICOL20Arm that receives CACICOL20 treatment each 2 days for 3 months/until closure of the ulcer |
| Placebo | Placebo comparator | Device: PlaceboThe placebo is applicated each 2 days on patient cornea for 3 months/ until ulcer closure. |
| CACICOL20 and Placebo | Experimental | Device: CACICOL20Patient 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CACICOL20CACICOL20 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. | Device | CACICOL20, CACICOL20 and Placebo |
| PlaceboIt 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. | Device | Placebo |
Primary outcome
Healing rate
Time frame: Within 1 months
The main judgment criteria is healing rate within 3 months defined as corneal ulcer complete closure.
3 secondary outcomes
Healing rate
Time frame: 2 and 3 months
Visual pain scale
Time frame: 1, 2 and 3 months
Associated treatments quotation
Time frame: 1, 2 and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe Baudouin, MD principal investigator
XV- XX Hospital - Paris
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CACICOL20 in people with Corneal Ulcer, run by Organ, Tissue, Regeneration, Repair and Replacement at 21 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing rate (time frame: Within 1 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2016.