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

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.

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.

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