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

Not Applicable

Completed

• Conditions: Cornea Ulcer
• Interventions: Drug: Naltrexone Hydrochloride; Drug: Carboxy methyl cellulose

• Registration Number: NCT05924893
• Lead Sponsor: Minia University

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.

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 Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-06-01
• Study Completion: 2022-12-15
• Status Verified: 2023-06
• Study First Submitted: 2023-06-11
• Study First Submitted QC: 2023-06-20
• Last Update Submitted: 2023-06-20
• Study First Posted: 2023-06-29
• Last Update Posted: 2023-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• refractory non infective corneal ulcer

Exclusion Criteria

• infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naltrexone group	Naltrexone Hydrochloride	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
Control	Carboxy methyl cellulose	25 eyes with refractory non infective corneal ulcer were treated by carboxymethyl cellulose sodium 0.5 % eye drops

Primary Outcome Measures

Name	Time	Method
healing of ulcer	2 weeks	healing of ulcer measured in millemeters by clinical examination on slit lamp after staining with sodium fluorescein stain

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Minya, Egypt