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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-03

Study Completion Date

2019-01-17

Brief Summary

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

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Detailed Description

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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

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Cornea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active treatment

20 patients will be treated with active treatment (OMK2)

Group Type ACTIVE_COMPARATOR

OMK2

Intervention Type DEVICE

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

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

Group Type PLACEBO_COMPARATOR

OMK2

Intervention Type DEVICE

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).

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes