NCT03906513

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Milan · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Cornea

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2017-05-03
• Primary completion: 2017-05-03
• Completion: 2019-01-17
• First posted: 2019-04-08
• Last updated: 2019-05-09

Locations

1 site across 1 country: Italy