Evaluation of the Efficacy of OMK2 in Recovering Corneal Neural Damage in Patients With Diabetes

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

Study Overview

• Status: Completed
• Conditions: Cornea
• Intervention / Treatment: Device: OMK2

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • MI
    • Milano, MI, Italy, 20142
      • ASST Santi Paolo e Carlo - Ospedale San Paolo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active treatment; 20 patients will be treated with active treatment (OMK2)	Device: OMK2; 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).
Placebo Comparator: Placebo; 10 patients will be treated with placebo (lubricant eye drops)	Device: OMK2; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
- 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)	Change measure (baseline and month 18)

Collaborators and Investigators

• Sponsor: University of Milan
• Investigators: Principal Investigator: Paolo Fogagnolo, MD, University of Milan

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2017
• Primary Completion (Actual): May 3, 2017
• Study Completion (Actual): January 17, 2019

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: April 5, 2019
• First Posted (Actual): April 8, 2019

Study Record Updates

• Last Update Posted (Actual): May 9, 2019
• Last Update Submitted That Met QC Criteria: May 6, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Diabetes; Cornea; Neural damage
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases
• Other Study ID Numbers: OMK20915

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No