KeratoconusPhase 4NCT02119039
Effect of CACICOL20 on Corneal Epithelial Healing After Cross-linking in Patients With Keratoconus
A Phase 4 study testing RGTA OTR 4120 (CACICOL20) and Genteal HA eye drops in people with Keratoconus, run by Medical University of Vienna at 1 site in Austria.
Trial summary
CACICOL20 is an ophthalmic solution based on the technology of RGTAs (ReGeneraTingAgents). It consists of large biopolymers, imitating the structure of heparansulphate. The protecting effect on different biological tissues and enhancement of wound healing has been described in several studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconus
- What is being tested?
- RGTA OTR 4120 (CACICOL20) and Genteal HA eye drops
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2014to Dec 2015
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged over 18 years
- Presence of keratoconus
- Scheduled for corneal cross linking
- No ophthalmic surgery in the 3 months preceding the study
Who cannot join
- Participation in a clinical trial in the previous 3 weeks
- Topical use of aminoglycosid antibiotics
- Use of therapeutic or refractive contact lenses after surgery
- Known hypersensitivity to any component of the study medication or heparinoids or heparin
- Active ocular infection
- Presence of any abnormalities preventing reliable measurements as judged by the investigator
- Pregnancy, planned pregnancy or lactating
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090
About this study
CACICOL20 is an ophthalmic solution based on the technology of RGTAs (ReGeneraTingAgents). It consists of large biopolymers, imitating the structure of heparansulphate. The protecting effect on different biological tissues and enhancement of wound healing has been described in several studies.
Keratoconus is a relatively common disease, with incidences ranging from 1.3 to 25 per 100,000 per year across different populations. Corneal collagen cross-linking represents a treatment option for these patients, aiming to prevent progression of the disease via stabilization of corneal microstructure. Corneal epithelial removal prior to the ultraviolet A/riboflavin cross-linking procedure significantly improves the outcome of the intervention, due to ameliorated distribution of riboflavin.
The aim of the present study is to investigate the effect of CACICOL20 on corneal epithelial wound closure after collagen cross-linking in patients with keratoconus. Results may lead to an improved management and pain reduction of patients with corneal epithelial defects.
- Conditions
- Keratoconus
- Being tested
- RGTA OTR 4120 (CACICOL20), Genteal HA eye drops
- Keywords
- Cross-linking, RGTA OTR4120 (CACICOL20)
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RGTA OTR 4120 (CACICOL20)Device
Genteal HA eye dropsDevice
| Study group | Role | What they receive |
|---|---|---|
| RGTA OTR 4120 (CACICOL20) | Experimental | Not described Receives: Device: RGTA OTR 4120 (CACICOL20) |
| Genteal HA | Active comparator | Not described Receives: Device: Genteal HA eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to closure of the epithelial wound
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katarzyna J. Witkowska, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119039
- Sponsor's protocol ID
- OPHT-070214
- Status last verified
- Dec 2015
- First submitted
- 21 Mar 2014
- Last updated
- 22 Dec 2015
- Results posted
- No
Publications
Bata AM, Witkowska KJ, Wozniak PA, Fondi K, Schmidinger G, Pircher N, Szegedi S, Aranha Dos Santos V, Pantalon A, Werkmeister RM, Garhofer G, Schmetterer L, Schmidl D. Effect of a Matrix Therapy Agent on Corneal Epithelial Healing After Standard Collagen Cross-linking in Patients With Keratoconus: A Randomized Clinical Trial. JAMA Ophthalmol. 2016 Oct 1;134(10):1169-1176. doi: 10.1001/jamaophthalmol.2016.3019.
PubMed 27584715
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of CACICOL20 on Corneal Epithelial Healing After Cross-linking in Patients With Keratoconus
- ClinicalTrials.gov ID
- NCT02119039
- Acronym / sponsor ID
- OPHT-070214
- Conditions
- Keratoconus
- Keywords
- Cross-linking, RGTA OTR4120 (CACICOL20)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Apr 2014 (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 an ophthalmic solution based on the technology of RGTAs (ReGeneraTingAgents). It consists of large biopolymers, imitating the structure of heparansulphate. The protecting effect on different biological tissues and enhancement of wound healing has been described in several studies.
Keratoconus is a relatively common disease, with incidences ranging from 1.3 to 25 per 100,000 per year across different populations. Corneal collagen cross-linking represents a treatment option for these patients, aiming to prevent progression of the disease via stabilization of corneal microstructure. Corneal epithelial removal prior to the ultraviolet A/riboflavin cross-linking procedure significantly improves the outcome of the intervention, due to ameliorated distribution of riboflavin.
The aim of the present study is to investigate the effect of CACICOL20 on corneal epithelial wound closure after collagen cross-linking in patients with keratoconus. Results may lead to an improved management and pain reduction of patients with corneal epithelial defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RGTA OTR 4120 (CACICOL20) | Experimental | Device: RGTA OTR 4120 (CACICOL20) |
| Genteal HA | Active comparator | Device: Genteal HA eye drops |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged over 18 years
- Presence of keratoconus
- Scheduled for corneal cross linking
- No ophthalmic surgery in the 3 months preceding the study
Key exclusion criteria (7 listed)
- Participation in a clinical trial in the previous 3 weeks
- Topical use of aminoglycosid antibiotics
- Use of therapeutic or refractive contact lenses after surgery
- Known hypersensitivity to any component of the study medication or heparinoids or heparin
- Active ocular infection
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 |
|---|---|---|
| RGTA OTR 4120 (CACICOL20) | Device | RGTA OTR 4120 (CACICOL20) |
| Genteal HA eye drops | Device | Genteal HA |
Primary outcome
Time to closure of the epithelial wound
Time frame: 5 days
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 22 Dec 2015.
- Derived from this study: PubMed 27584715Bata AM, Witkowska KJ, Wozniak PA, Fondi K, Schmidinger G, Pircher N, Szegedi S, Aranha Dos Santos V, Pantalon A, Werkmeister RM, Garhofer G, Schmetterer L, Schmidl D. Effect of a Matrix Therapy Agent on Corneal Epithelial Healing After Standard Collagen Cross-linking in Patients With Keratoconus: A Randomized Clinical Trial. JAMA Ophthalmol. 2016 Oct 1;134(10):1169-1176. doi: 10.1001/jamaophthalmol.2016.3019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing RGTA OTR 4120 (CACICOL20) and Genteal HA eye drops in people with Keratoconus, run by Medical University of Vienna at 1 site in Austria.
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 4 inclusion and 7 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 22 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to closure of the epithelial wound (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02119039, which also lists 1 linked publication.
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 22 Dec 2015.