The Use of Naltrexone Hydrochloride to Promote Healing in Patients With Resistant Non-infectious Corneal Ulcer
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2022
CompletedFirst Submitted
Initial submission to the registry
June 11, 2023
CompletedFirst Posted
Study publicly available on registry
June 29, 2023
CompletedJune 29, 2023
June 1, 2023
1.4 years
June 11, 2023
June 20, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
healing of ulcer
healing of ulcer measured in millemeters by clinical examination on slit lamp after staining with sodium fluorescein stain
2 weeks
Study Arms (2)
Naltrexone group
EXPERIMENTAL25 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
EXPERIMENTAL25 eyes with refractory non infective corneal ulcer were treated by carboxymethyl cellulose sodium 0.5 % eye drops
Interventions
Carboxy methyl cellulose drops
Eligibility Criteria
You may qualify if:
- refractory non infective corneal ulcer
You may not qualify if:
- infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Minia Universitylead
Study Sites (1)
Faculty of Medicine
Minya, Egypt
Related Publications (1)
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.
PMID: 17324465BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hossam Moharram, professor
Minia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
June 11, 2023
First Posted
June 29, 2023
Study Start
January 1, 2021
Primary Completion
June 1, 2022
Study Completion
December 15, 2022
Last Updated
June 29, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share