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

University of Milan

Status

Completed

Conditions

Cornea

Treatments

Device: OMK2

Study type

Interventional

Funder types

Other

Identifiers

NCT03906513

OMK20915

Details and patient eligibility

About

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

Full 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.

Enrollment

30 patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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