CorneaNCT03906513
Evaluation of the Efficacy of OMK2 in Recovering Corneal Neural Damage in Patients With Diabetes
A study testing OMK2 in people with Cornea, run by University of Milan at 1 site in Italy.
Trial summary
This will be a single-centre, randomized, pilot study. 30 patients with diabetes who previously had received Argon laser photocoagulation will be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cornea
- What is being tested?
- OMK2
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 3 May 2017to 17 Jan 2019
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Type 1 or type 2 diabetic patients who received Argon Laser Photocoagulation
Who cannot join
- Neuropathy of any other cause than diabetes
- A history of conditions known to affect corneal sensitivity
- Coexisting other corneal diseases
- Autoimmune diseases
- Sjogren syndrome
- History of corneal trauma
Show all 11Show fewer
- Contact lenses users
- Patients needing eye surgery or who received eye surgery at least 180 days before study beginning.
- contraindications to the use of any active substances and/or excipients
- pregnant and lactating women
- pediatric patients or adolescents under 18 years
Trial locations and contacts
1 site in 1 country.
About this study
This will be a single-centre, randomized, pilot study. 30 patients with diabetes who previously had received Argon laser photocoagulation will be enrolled.
Read the detailed description
This will be a single-centre, randomized, pilot study. 30 patients with diabetes who previously had received Argon laser photocoagulation will be enrolled. These patients will receive corneal esthesiometry and will be divided in those with esthesiometry < 45 mm [6] (clinically detectable corneal neuropathy, CDCN) and not (NCDCN).
Patients will be randomized to the two treatment arms: 20 patients will be treated with active treatment (OMK2) and 10 patients will be treated with placebo (lubricant eye drops) given three times daily (8 am, 2 pm, 8 pm) for 18 months. Stratification for (1) CDCN, (2) duration of the disease, and (3) insulin-dependent diabetes will be adopted.
The randomization will be operator-masked.
- Conditions
- Cornea
- Being tested
- OMK2
- Keywords
- Cornea, Diabetes, Neural damage
- Medical subject headings
- Corneal Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMK2Device
OMK2 (including citicoline 2%, high molecular weight hyaluronic acid 0.2%, cyanocobalamin and 0.01% BAK, Omikron Italia SRL) is a Class IIa device CE marked registered in Medical Devices Database of Italian Ministry of Health (identification number of registration: 1170558).
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Active comparator | 20 patients will be treated with active treatment (OMK2) Receives: Device: OMK2 |
| Placebo | Placebo comparator | 10 patients will be treated with placebo (lubricant eye drops) Receives: Device: OMK2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in the characteristics of the subbasal corneal plexus at confocal
changes in the characteristics of the subbasal corneal plexus at confocal microscopy (central + 8 paracentral quadrants)
- changes in corneal esthesiometry (Cochet-Bonnet esthesiometer); central and four quadrants changes in the characteristics of the subbasal corneal plexus at confocal microscopy (central + 8 paracentral quadrants)
- changes in corneal esthesiometry (Cochet-Bonnet esthesiometer); central and changes in the characteristics of the subbasal corneal plexus at confocal microscopy (central + 8 paracentral quadrants)
- changes in corneal esthesiometry (Cochet-Bonnet esthesiometer); central and four quadrants four quadrants
Measured: Change measure (baseline and month 18)
Secondary outcomes (1)
- changes in clinical signs and symptoms of ocular surface damage
- changes in clinical signs of corneal damage (BUT, Schirmer I, corneal and conjunctival epithelial staining using Oxford and Van Bijelsterveld scales, both ranging between 0 - normal, to 4 - severely affected; a change of 1 or more stage is defined as clinically relevant)
- changes in symptoms (OSDI)
Measured: Change measure (baseline and month 18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start3 May 2017
- Primary completion3 May 2017
- Study completion17 Jan 2019
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 CorneaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Fogagnolo, University of Milan
- Investigators
- Paolo Fogagnolo, MD, Principal investigator, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906513
- Sponsor's protocol ID
- OMK20915
- Status last verified
- May 2019
- First submitted
- 4 Apr 2019
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fogagnolo P, Melardi E, Tranchina L, Rossetti L. Topical citicoline and vitamin B12 versus placebo in the treatment of diabetes-related corneal nerve damage: a randomized double-blind controlled trial. BMC Ophthalmol. 2020 Aug 1;20(1):315. doi: 10.1186/s12886-020-01584-w.
PubMed 32738875
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of OMK2 in Recovering Corneal Neural Damage in Patients With Diabetes
- ClinicalTrials.gov ID
- NCT03906513
- Acronym / sponsor ID
- OMK20915
- Conditions
- Cornea
- Keywords
- Cornea, Diabetes, Neural damage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 3 May 2017 (actual)
- Primary completion
- 3 May 2017 (actual)
- Study completion
- 17 Jan 2019 (actual)
- First posted
- 8 Apr 2019 (actual)
- 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.
This will be a single-centre, randomized, pilot study. 30 patients with diabetes who previously had received Argon laser photocoagulation will be enrolled.
Detailed description
This will be a single-centre, randomized, pilot study. 30 patients with diabetes who previously had received Argon laser photocoagulation will be enrolled. These patients will receive corneal esthesiometry and will be divided in those with esthesiometry < 45 mm [6] (clinically detectable corneal neuropathy, CDCN) and not (NCDCN).
Patients will be randomized to the two treatment arms: 20 patients will be treated with active treatment (OMK2) and 10 patients will be treated with placebo (lubricant eye drops) given three times daily (8 am, 2 pm, 8 pm) for 18 months. Stratification for (1) CDCN, (2) duration of the disease, and (3) insulin-dependent diabetes will be adopted.
The randomization will be operator-masked.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Active comparator | Device: OMK220 patients will be treated with active treatment (OMK2) |
| Placebo | Placebo comparator | Device: OMK210 patients will be treated with placebo (lubricant eye drops) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 18 years old
- Type 1 or type 2 diabetic patients who received Argon Laser Photocoagulation
Key exclusion criteria (11 listed)
- Neuropathy of any other cause than diabetes
- A history of conditions known to affect corneal sensitivity
- Coexisting other corneal diseases
- Autoimmune diseases
- Sjogren syndrome
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 |
|---|---|---|
| OMK2OMK2 (including citicoline 2%, high molecular weight hyaluronic acid 0.2%, cyanocobalamin and 0.01% BAK, Omikron Italia SRL) is a Class IIa device CE marked registered in Medical Devices Database of Italian Ministry of Health (identification number of registration: 1170558). | Device | Active treatment, Placebo |
Primary outcome
changes in the characteristics of the subbasal corneal plexus at confocal
Time frame: Change measure (baseline and month 18)
changes in the characteristics of the subbasal corneal plexus at confocal microscopy (central + 8 paracentral quadrants) * changes in corneal esthesiometry (Cochet-Bonnet esthesiometer); central and four quadrants changes in the characteristics of the subbasal corneal plexus at confocal microscopy (central + 8 paracentral quadrants) * changes in corneal esthesiometry (Cochet-Bonnet esthesiometer); central and changes in the characteristics of the subbasal corneal plexus at confocal microscopy (central + 8 paracentral quadrants) * changes in corneal esthesiometry (Cochet-Bonnet esthesiometer); central and four quadrants four quadrants
1 secondary outcome
- changes in clinical signs and symptoms of ocular surface damage
Time frame: Change measure (baseline and month 18)
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 9 May 2019.
- Derived from this study: PubMed 32738875Fogagnolo P, Melardi E, Tranchina L, Rossetti L. Topical citicoline and vitamin B12 versus placebo in the treatment of diabetes-related corneal nerve damage: a randomized double-blind controlled trial. BMC Ophthalmol. 2020 Aug 1;20(1):315. doi: 10.1186/s12886-020-01584-w.
- Individual participant dataSharing planned: No
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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.
Paolo Fogagnolo, MD principal investigator
University of Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OMK2 in people with Cornea, run by University of Milan at 1 site in Italy.
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 2 inclusion and 11 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 9 May 2019. 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 Italy. 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?
changes in the characteristics of the subbasal corneal plexus at confocal (time frame: Change measure (baseline and month 18)). 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 NCT03906513, 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 9 May 2019; AzTrials last refreshed its copy on 8 Nov 2026.