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

Cornea Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03906513
Study type Interventional
Source University of Milan
Contact
Status Completed
Phase N/A
Start date May 3, 2017
Completion date January 17, 2019
View Details
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