Ignite Creation Date:
2024-05-06 @ 7:12 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05924893
Status:
COMPLETED
Last Update Posted:
2023-06-29
First Post:
2023-06-11
Brief Title:
The Use of Naltrexone Hydrochloride to Promote Healing in Patients With Resistant Non-infectious Corneal Ulcer
Sponsor:
Minia University
Organization:
Minia University
Study Overview
Official Title:
The Use of Naltrexone Hydrochloride to Promote Healing in Patients With Resistant Non-infectious Corneal Ulcer
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Bowmans 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None