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 Details — Status: Completed

Administrative data

• NCT number: NCT03906513
• Other study ID #: OMK20915
• Status: Completed
• Phase: N/A
• Start date: May 3, 2017
• Est. completion date: January 17, 2019

Study information

• Verified date: May 2019
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 17, 2019
• Est. primary completion date: May 3, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cornea

Intervention

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).

Locations

Country	Name	City	State
Italy	ASST Santi Paolo e Carlo - Ospedale San Paolo	Milano	MI

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change measure (baseline and month 18)
Secondary	- 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)	Change measure (baseline and month 18)