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

Sponsor
Minia University (Other)
Overall Status
Completed
CT.gov ID
NCT05924893
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
23.4
Actual Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Naltrexone Hydrochloride
  • Drug: Carboxy methyl cellulose
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Use of Naltrexone Hydrochloride to Promote Healing in Patients With Resistant Non-infectious Corneal Ulcer
Actual Study Start Date :
Jan 1, 2021
Actual Primary Completion Date :
Jun 1, 2022
Actual Study Completion Date :
Dec 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Drug: Naltrexone Hydrochloride
naltrexone film
Other Names:
  • NTX

    		•
    Experimental: Control

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

    Drug: Carboxy methyl cellulose
    Carboxy methyl cellulose drops
    Other Names:
  • Carboxy methyl cellulose sodium 0.5%

    		•

    Outcome Measures

    Primary Outcome Measures

    1. healing of ulcer [2 weeks]

      healing of ulcer measured in millemeters by clinical examination on slit lamp after staining with sodium fluorescein stain

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • refractory non infective corneal ulcer
    Exclusion Criteria:
    • infection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine Minya Egypt

    Sponsors and Collaborators

    • Minia University

    Investigators

    • Principal Investigator: Hossam Moharram, professor, Minia University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ahemd Abdelghany, Associate professor, Minia University
    ClinicalTrials.gov Identifier:
    NCT05924893
    Other Study ID Numbers:
    • 2015
    First Posted:
    Jun 29, 2023
    Last Update Posted:
    Jun 29, 2023
    Last Verified:
    Jun 1, 2023
    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
    Additional relevant MeSH terms:
    Corneal Ulcer
    Ulcer
    Naltrexone

    Study Results

    No Results Posted as of Jun 29, 2023