Neurotrophic KeratopathyPhase 4NCT06331910
Efficacy and Safety of Topical Insulin for Neurotrophic Corneal Ulcers
A Phase 4 study testing insulin eye drops in people with Neurotrophic Keratopathy, run by Assiut University.
Trial summary
To evaluate Safety and efficacy of topical insulin in treatment of neurotrophic corneal ulcers Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Neurotrophic Keratopathy
- What is being tested?
- insulin eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 May 2025
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with neurotrophic corneal ulcers caused by:
- Herpes simplex or Herpes zoster viral infection
- Topical anesthetics abuse
- Chemical and physical burn
- Chronic CL wear
- Following LASIK,PRK,CXL
Show all 10Show fewer
- Following vitrectomy and endophotocoagulation for retinal detachment
- Diabetes mellitus
- Leprosy
- Trigeminal neuralgia surgery
Who cannot join
- Non compliant patients with the study protocol
About this study
Official title: Topical Insulin in Treatment of Neurotrophic Corneal Ulcer,Efficacy And Safety
To evaluate Safety and efficacy of topical insulin in treatment of neurotrophic corneal ulcers
Read the detailed description
Neurotrophic keratopathy is a degenerative disease of the corneal epithelium resulting from impaired corneal innervation. A reduction In corneal sensitivity or complete corneal anesthesia is the hallmark of this disease and is responsible for producing epithelial keratopathy, ulceration and perforation.
Because decreased corneal sensitivity is the hallmark sign of neurotrophic keratitis (NK), corneal sensitivity testing should be performed as soon as It is suspected
There are 2 common ways to test-one qualitative, the other quantitative:
The qualitative method is most commonly used In clinic and often achieved with a cotton tipped applicator because It is easily accessible.
The most common quantitative method is the handheld esthesiometer (Cochet-Bonnet).
Standard treatment of neurotrophic corneal ulcer involves aggressive lubrication of the corneal surface, therapeutic contact lenses, amniotic membrane grafts and tarsorrhaphy . Refractory neurotrophic corneal ulcers occur when treatment response is incomplete and are potentially blinding.
Insulin is a widely available, relatively safe, and familiar medication that has been shown to improve corneal epithelial healing In vitro and in diabetic animal models. However, clinical experience with topical insulin in patients with non-healing corneal wounds is minimal.
Insulin-like growth factor-1 (IGF-1) has been shown to be an important modulator of corneal wound healing.
Topical insulin may be a simple and effective treatment for neurotrophic corneal ulcers.
The main outcome measurements for improvement are the decrease of ulcer size by fluroscien stain,the increase in visual acuity.
- Conditions
- Neurotrophic Keratopathy
- Being tested
- insulin eye drops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin eye dropsDrug
Insulin eye drops deliver insulin directly to the cornea, They exploit insulin's ability to stimulate cell growth, potentially reducing healing time with minimal side effects.
| Study group | Role | What they receive |
|---|---|---|
| insulin eye drop | Experimental | Not described Receives: Drug: insulin eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in ulcer size and the increase in visual acuity .
To evaluate the effect of topical insulin eye drops in treatment of neurotrophic corneal ulcer.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neurotrophic KeratopathyStudies of the same condition, open and under way.
- More trials run by Assiut 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gehad Abd Elrahim Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331910
- Sponsor's protocol ID
- TITNCUES
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang AL, Weinlander E, Metcalf BM, Barney NP, Gamm DM, Nehls SM, Struck MC. Use of Topical Insulin to Treat Refractory Neurotrophic Corneal Ulcers. Cornea. 2017 Nov;36(11):1426-1428. doi: 10.1097/ICO.0000000000001297.
PubMed 28742619Shanley LJ, McCaig CD, Forrester JV, Zhao M. Insulin, not leptin, promotes in vitro cell migration to heal monolayer wounds in human corneal epithelium. Invest Ophthalmol Vis Sci. 2004 Apr;45(4):1088-94. doi: 10.1167/iovs.03-1064.
PubMed 15037573Zagon IS, Klocek MS, Sassani JW, McLaughlin PJ. Use of topical insulin to normalize corneal epithelial healing in diabetes mellitus. Arch Ophthalmol. 2007 Aug;125(8):1082-8. doi: 10.1001/archopht.125.8.1082.
PubMed 17698755Nishida T, Yanai R. Advances in treatment for neurotrophic keratopathy. Curr Opin Ophthalmol. 2009 Jul;20(4):276-81. doi: 10.1097/icu.0b013e32832b758f.
PubMed 19537364
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Insulin in Treatment of Neurotrophic Corneal Ulcer,Efficacy And Safety
- ClinicalTrials.gov ID
- NCT06331910
- Acronym / sponsor ID
- TITNCUES
- Conditions
- Neurotrophic Keratopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 26 Mar 2024 (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.
To evaluate Safety and efficacy of topical insulin in treatment of neurotrophic corneal ulcers
Detailed description
Neurotrophic keratopathy is a degenerative disease of the corneal epithelium resulting from impaired corneal innervation. A reduction In corneal sensitivity or complete corneal anesthesia is the hallmark of this disease and is responsible for producing epithelial keratopathy, ulceration and perforation.
Because decreased corneal sensitivity is the hallmark sign of neurotrophic keratitis (NK), corneal sensitivity testing should be performed as soon as It is suspected
There are 2 common ways to test-one qualitative, the other quantitative:
The qualitative method is most commonly used In clinic and often achieved with a cotton tipped applicator because It is easily accessible.
The most common quantitative method is the handheld esthesiometer (Cochet-Bonnet).
Standard treatment of neurotrophic corneal ulcer involves aggressive lubrication of the corneal surface, therapeutic contact lenses, amniotic membrane grafts and tarsorrhaphy . Refractory neurotrophic corneal ulcers occur when treatment response is incomplete and are potentially blinding.
Insulin is a widely available, relatively safe, and familiar medication that has been shown to improve corneal epithelial healing In vitro and in diabetic animal models. However, clinical experience with topical insulin in patients with non-healing corneal wounds is minimal.
Insulin-like growth factor-1 (IGF-1) has been shown to be an important modulator of corneal wound healing.
Topical insulin may be a simple and effective treatment for neurotrophic corneal ulcers.
The main outcome measurements for improvement are the decrease of ulcer size by fluroscien stain,the increase in visual acuity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| insulin eye drop | Experimental | Drug: insulin eye drops |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Patients with neurotrophic corneal ulcers caused by:
Key exclusion criteria (1 listed)
- Non compliant patients with the study protocol
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 |
|---|---|---|
| insulin eye dropsInsulin eye drops deliver insulin directly to the cornea, They exploit insulin's ability to stimulate cell growth, potentially reducing healing time with minimal side effects. | Drug | insulin eye drop |
Primary outcome
Decrease in ulcer size and the increase in visual acuity .
Time frame: baseline
To evaluate the effect of topical insulin eye drops in treatment of neurotrophic corneal ulcer.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Background: PubMed 28742619Wang AL, Weinlander E, Metcalf BM, Barney NP, Gamm DM, Nehls SM, Struck MC. Use of Topical Insulin to Treat Refractory Neurotrophic Corneal Ulcers. Cornea. 2017 Nov;36(11):1426-1428. doi: 10.1097/ICO.0000000000001297.
- Background: PubMed 15037573Shanley LJ, McCaig CD, Forrester JV, Zhao M. Insulin, not leptin, promotes in vitro cell migration to heal monolayer wounds in human corneal epithelium. Invest Ophthalmol Vis Sci. 2004 Apr;45(4):1088-94. doi: 10.1167/iovs.03-1064.
- Background: PubMed 17698755Zagon IS, Klocek MS, Sassani JW, McLaughlin PJ. Use of topical insulin to normalize corneal epithelial healing in diabetes mellitus. Arch Ophthalmol. 2007 Aug;125(8):1082-8. doi: 10.1001/archopht.125.8.1082.
- Background: PubMed 19537364Nishida T, Yanai R. Advances in treatment for neurotrophic keratopathy. Curr Opin Ophthalmol. 2009 Jul;20(4):276-81. doi: 10.1097/icu.0b013e32832b758f.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing insulin eye drops in people with Neurotrophic Keratopathy, run by Assiut University.
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 10 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: status not confirmed, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Decrease in ulcer size and the increase in visual acuity . (time frame: baseline). 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 NCT06331910, which also lists 4 linked publications.
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 26 Mar 2024.