NCT03906513

Brief Summary

This will be a single-centre, randomized, pilot study. 30 patients with diabetes who previously had received Argon laser photocoagulation will be enrolled.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2017

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2017

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
Last Updated

May 9, 2019

Status Verified

May 1, 2019

Enrollment Period

Same day

First QC Date

April 4, 2019

Last Update Submit

May 6, 2019

Conditions

Cornea

Keywords

CorneaDiabetesNeural damage

Outcome Measures

Primary Outcomes (1)

  • 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

    Change measure (baseline and month 18)

Secondary Outcomes (1)

  • - changes in clinical signs and symptoms of ocular surface damage

    Change measure (baseline and month 18)

Study Arms (2)

Active treatment

ACTIVE COMPARATOR

20 patients will be treated with active treatment (OMK2)

Device: OMK2

Placebo

PLACEBO COMPARATOR

10 patients will be treated with placebo (lubricant eye drops)

Device: OMK2

Interventions

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).

Active treatmentPlacebo

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years old
  • Type 1 or type 2 diabetic patients who received Argon Laser Photocoagulation

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASST Santi Paolo e Carlo - Ospedale San Paolo

Milan, MI, 20142, Italy

Location

Related Publications (1)

  • 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.

    PMID: 32738875DERIVED

MeSH Terms

Conditions

Corneal DiseasesDiabetes Mellitus

Condition Hierarchy (Ancestors)

Eye DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Paolo Fogagnolo, MD

    University of Milan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

April 4, 2019

First Posted

April 8, 2019

Study Start

May 3, 2017

Primary Completion

May 3, 2017

Study Completion

January 17, 2019

Last Updated

May 9, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)