Evaluation of the Efficacy of OMK2 in Recovering Corneal Neural Damage in Patients With Diabetes
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 |
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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
Arms and Interventions
Arm | Intervention/Treatment |
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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).
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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).
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Outcome Measures
Primary Outcome Measures
- 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
- - 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
Inclusion Criteria:
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At least 18 years old
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Type 1 or type 2 diabetic patients who received Argon Laser Photocoagulation
Exclusion Criteria:
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Neuropathy of any other cause than diabetes
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A history of conditions known to affect corneal sensitivity
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Coexisting other corneal diseases
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Autoimmune diseases
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Sjogren syndrome
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History of corneal trauma
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Contact lenses users
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Patients needing eye surgery or who received eye surgery at least 180 days before study beginning.
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contraindications to the use of any active substances and/or excipients
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pregnant and lactating women
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pediatric patients or adolescents under 18 years
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- OMK20915