Cornea UlcerNCT05924893
The Use of Naltrexone Hydrochloride to Promote Healing in Patients With Resistant Non-infectious Corneal Ulcer
A study testing Naltrexone Hydrochloride and Carboxy methyl cellulose in people with Cornea Ulcer, run by Minia University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cornea Ulcer
- What is being tested?
- Naltrexone Hydrochloride and Carboxy methyl cellulose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- refractory non infective corneal ulcer
Who cannot join
- infection
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Naltrexone Hydrochloride, Carboxy methyl cellulose
- Medical subject headings
- Corneal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone HydrochlorideDrug
Also called NTX
naltrexone film
Carboxy methyl celluloseDrug
Also called Carboxy methyl cellulose sodium 0.5%
Carboxy methyl cellulose drops
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone group | Experimental | 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 Receives: Drug: Naltrexone Hydrochloride |
| Control | Experimental | 25 eyes with refractory non infective corneal ulcer were treated by carboxymethyl cellulose sodium 0.5 % eye drops Receives: Drug: Carboxy methyl cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing of ulcer
healing of ulcer measured in millemeters by clinical examination on slit lamp after staining with sodium fluorescein stain
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start1 Jan 2021
- Primary completion1 Jun 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cornea UlcerStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahemd Abdelghany, Minia University
- Investigators
- Hossam Moharram, professor, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924893
- Sponsor's protocol ID
- 2015
- Status last verified
- Jun 2023
- First submitted
- 11 Jun 2023
- Last updated
- 29 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17324465
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Naltrexone Hydrochloride to Promote Healing in Patients With Resistant Non-infectious Corneal Ulcer
- ClinicalTrials.gov ID
- NCT05924893
- Acronym / sponsor ID
- 2015
- Conditions
- Cornea Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naltrexone group | Experimental | Drug: Naltrexone Hydrochloride25 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 | Experimental | Drug: Carboxy methyl cellulose25 eyes with refractory non infective corneal ulcer were treated by carboxymethyl cellulose sodium 0.5 % eye drops |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- refractory non infective corneal ulcer
Key exclusion criteria (1 listed)
- infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naltrexone HydrochlorideAlso: NTXnaltrexone film | Drug | Naltrexone group |
| Carboxy methyl celluloseAlso: Carboxy methyl cellulose sodium 0.5%Carboxy methyl cellulose drops | Drug | Control |
Primary outcome
healing of ulcer
Time frame: 2 weeks
healing of ulcer measured in millemeters by clinical examination on slit lamp after staining with sodium fluorescein stain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Background: PubMed 17324465Alio 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hossam Moharram, professor principal investigator
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Naltrexone Hydrochloride and Carboxy methyl cellulose in people with Cornea Ulcer, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
healing of ulcer (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05924893, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.