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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cornea

Intervention / Treatment
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* Device: OMK2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cornea, Diabetes, Neural damage