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

Sponsor
University of Milan (Other)
Overall Status
Completed
CT.gov ID
NCT03906513
Collaborator
(none)
30
1
2
20.5
1.5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: OMK2
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Efficacy of OMK2 in Recovering Corneal Neural Damage in Patients With Diabetes
Actual Study Start Date :
May 3, 2017
Actual Primary Completion Date :
May 3, 2017
Actual Study Completion Date :
Jan 17, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Active treatment

20 patients will be treated with active treatment (OMK2)

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).

Placebo Comparator: Placebo

10 patients will be treated with placebo (lubricant eye drops)

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).

Outcome Measures

Primary Outcome Measures

  1. changes in the characteristics of the subbasal corneal plexus at confocal [Change measure (baseline and month 18)]

    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

Secondary Outcome Measures

  1. - changes in clinical signs and symptoms of ocular surface damage [Change measure (baseline and month 18)]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 ASST Santi Paolo e Carlo - Ospedale San Paolo Milano MI Italy 20142

Sponsors and Collaborators

  • University of Milan

Investigators

  • Principal Investigator: Paolo Fogagnolo, MD, University of Milan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Paolo Fogagnolo, Researcher, University of Milan
ClinicalTrials.gov Identifier:
NCT03906513
Other Study ID Numbers:
  • OMK20915
First Posted:
Apr 8, 2019
Last Update Posted:
May 9, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Paolo Fogagnolo, Researcher, University of Milan
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 9, 2019