NCT05924893

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Minia University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cornea Ulcer

Interventions

Type	Name	Description
DRUG	Naltrexone Hydrochloride	naltrexone film
DRUG	Carboxy methyl cellulose	Carboxy methyl cellulose drops

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-06-01
• Completion: 2022-12-15
• First posted: 2023-06-29
• Last updated: 2023-06-29

Locations

1 site across 1 country: Egypt