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

University of Milan30 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cornea

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

ASST Santi Paolo e Carlo - Ospedale San Paolo

Milan, MI, Italy

Outcomes

Primary Outcomes

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

Time frame: Change measure (baseline and month 18)

Secondary Outcomes

- 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)

Time frame: Change measure (baseline and month 18)

Data from ClinicalTrials.gov

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