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

Primary Purpose

Cornea Ulcer

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Naltrexone Hydrochloride

Carboxy methyl cellulose

About this trial

This is an interventional treatment trial for Cornea Ulcer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: refractory non infective corneal ulcer Exclusion Criteria: infection

Sites / Locations

Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Naltrexone group

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

healing of ulcer

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05924893

First Posted

June 11, 2023

Last Updated

June 20, 2023

Sponsor

Minia University

1. Study Identification

Unique Protocol Identification Number

NCT05924893

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

January 1, 2021 (Actual)

Primary Completion Date

June 1, 2022 (Actual)

Study Completion Date

December 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cornea Ulcer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Naltrexone group

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Naltrexone Hydrochloride

Other Intervention Name(s)

NTX

Intervention Description

naltrexone film

Intervention Type

Drug

Intervention Name(s)

Carboxy methyl cellulose

Other Intervention Name(s)

Carboxy methyl cellulose sodium 0.5%

Intervention Description

Carboxy methyl cellulose drops

Primary Outcome Measure Information:

Title

healing of ulcer

Description

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

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: refractory non infective corneal ulcer Exclusion Criteria: infection

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hossam Moharram, professor

Organizational Affiliation

Minia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Medicine

City

Minya

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

17324465

Citation

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.

Results Reference

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

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