The Use of Naltrexone Hydrochloride to Promote Healing in Patients With Resistant Non-infectious Corneal Ulcer

Study Overview
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Brief Summary
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The opioid growth factor-receptor antagonist-naltrexone hydrochloride (NTX)- has gained much reach interest for applications in ophthalmology, because of its novel mechanism of action for speeding up corneal wound healing in both diabetics and non-diabetics, effective both locally and systemically and its availability as a low molecular weight synthetic drug.

Detailed Description
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Corneal epithelial defects generally heal within 2 days without complications, in some patients with decreased corneal sensitivity, such as patients with severe dry eye, corneal neuropathy, or autoimmune diseases, the corneal epithelium shows a reduced tendency for spontaneous healing Resistant corneal ulcers may appear as epithelial defects associated to Bowman's layer disruption with associated damage and partial variable loss of superficial corneal stroma larger than 2 mm in diameter that persist more than 2 weeks even treated with conventional treatment . Noninfectious corneal ulcers have a similar clinical presentation like that of infectious ulcers but with no known infectious cause . Resistant corneal ulcer can lead to serious complications such as infection, inflammation, corneal scarring, opacification, corneal thinning, and perforation . In our study NTX accelerated healing of resistant corneal ulcers that was refractory to conventional treatment with lubricant eye drops and was safe with no complications reported in all treated eyes.

Official Title
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The Use of Naltrexone Hydrochloride to Promote Healing in Patients With Resistant Non-infectious Corneal Ulcer

Conditions
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Cornea Ulcer

Intervention / Treatment
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* Drug: Naltrexone Hydrochloride
* Drug: Carboxy methyl cellulose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: refractory non infective corneal ulcer Exclusion Criteria: infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naltrexone group<br>25 eyes with refractory non infective corneal ulcer were subjected to daily insertion of a NTX film in the lower conjunctival fornix for 2 weeks | Drug: Naltrexone Hydrochloride<br>* naltrexone film<br>* Other names: NTX;|
| Experimental: Control<br>25 eyes with refractory non infective corneal ulcer were treated by carboxymethyl cellulose sodium 0.5 % eye drops | Drug: Carboxy methyl cellulose<br>* Carboxy methyl cellulose drops<br>* Other names: Carboxy methyl cellulose sodium 0.5%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| healing of ulcer | healing of ulcer measured in millemeters by clinical examination on slit lamp after staining with sodium fluorescein stain | 2 weeks |