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

NCT ID: NCT05924893

Last Updated: 2023-06-29

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-12-15

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.

Conditions

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Cornea Ulcer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Naltrexone group

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

Group Type EXPERIMENTAL

Naltrexone Hydrochloride

Intervention Type DRUG

naltrexone film

Control

25 eyes with refractory non infective corneal ulcer were treated by carboxymethyl cellulose sodium 0.5 % eye drops

Group Type EXPERIMENTAL

Carboxy methyl cellulose

Intervention Type DRUG

Carboxy methyl cellulose drops

Interventions

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Naltrexone Hydrochloride

naltrexone film

Intervention Type DRUG

Carboxy methyl cellulose

Carboxy methyl cellulose drops

Intervention Type DRUG

Other Intervention Names

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NTX Carboxy methyl cellulose sodium 0.5%

Eligibility Criteria

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Inclusion Criteria

* refractory non infective corneal ulcer

Exclusion Criteria

* infection
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Ahemd Abdelghany

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hossam Moharram, professor

Role: PRINCIPAL_INVESTIGATOR

Minia University

Locations

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Faculty of Medicine

Minya, , Egypt

Site Status

Countries

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Egypt

References

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Alio JL, Abad M, Artola A, Rodriguez-Prats JL, Pastor S, Ruiz-Colecha J. Use of autologous platelet-rich plasma in the treatment of dormant corneal ulcers. Ophthalmology. 2007 Jul;114(7):1286-1293.e1. doi: 10.1016/j.ophtha.2006.10.044. Epub 2007 Feb 26.

Reference Type BACKGROUND
PMID: 17324465 (View on PubMed)

Other Identifiers

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2015

Identifier Type: -

Identifier Source: org_study_id