Neurotrophic KeratitisPhase 2/3NCT05321251
Topical Insulin Drops for the Treatment of Neurotrophic Keratopathy.
A Phase 2/3 study testing Insulin and Tarsorrhaphy in people with Neurotrophic Keratitis, run by University of Alberta at 6 sites in Canada.
Trial summary
Many diseases can affect corneal nerves. Corneas that lack normal sensation are considered neurotrophic. Neurotrophic corneas are predisposed to persistent epithelial defects, recurrent erosions, and corneal ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurotrophic Keratitis
- What is being tested?
- Insulin and Tarsorrhaphy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 6 sitesCanada
- Study dates
- 1 Jun 2022to 18 Oct 2023
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of neurotrophic keratitis with persistent epithelial defect that has been refractory to conventional treatments for at least 2 weeks
- 18 years or older
- Able to provide informed consent
- Failed other conventional treatments for neurotrophic keratitis
- Understanding and accepting of use of topical insulin alone
Who cannot join
- Less than 18 years old
- Pregnant or breastfeeding women
- Unable to provide informed consent
- Unable to comply with tests/follow-up
- Lid function abnormalities (e.g., lagophthalmos, entropion, ectropion, or abnormal orbicularis function from cranial nerve 7 palsy or Bell's palsy)
- Patients who require ongoing topical treatment (e.g. topical ganciclovir)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
University of Alberta
Edmonton, Alberta, T6G 2C8
Dalhousie University
Halifax, Nova Scotia
University of Montreal
Montreal, Quebec
Precision Cornea Clinic
Ottawa, Ontario
University of Toronto
Toronto, Ontario
University of British Columbia
Vancouver, British Columbia
About this study
Many diseases can affect corneal nerves. Corneas that lack normal sensation are considered neurotrophic. Neurotrophic corneas are predisposed to persistent epithelial defects, recurrent erosions, and corneal ulcers. These can lead to a variety of complications, from subjective pain, discomfort, and blurry vision, to corneal perforation and endophthalmitis. Neurotrophic corneas and the persistent epithelial defects associated with them can be very difficult to treat. Non-invasive measures include topical drops (artificial tears, antibiotics, or steroids), bandage contact lens, and punctal plugs. More invasive surgical treatments include membrane grafts, tarsorrhaphy, and keratoplasty. Despite these treatments, many neurotrophic corneas still do not heal. This study aims to test the efficacy of topical insulin in the treatment of neurotrophic keratopathy.
Read the detailed description
Purpose: To trial topical insulin drops to promote healing in neurotrophic keratitis that has been refractory to conventional management versus tarsorrhaphy.
Hypothesis: Topical insulin might promote re-epithelialization in the setting of neurotrophic keratitis (Stage 2 or 3) with persistent epithelial defect refractory to conventional treatments and be a non-inferior treatment to tarsorrhaphy.
Justification: Several experiments support the use of insulin for the promotion of corneal epithelial healing. In vitro experiments with immortalized corneal epithelial cells suggest that insulin improves epithelial cell migration. A rabbit model showed improvement in corneal hypoesthesia after topical insulin exposure. These results suggest that early hypoesthesia may be reversible, and thereby improve epithelial wound healing. Another rabbit model showed that topical insulin might alter the corneal surface by increasing the tensile strength of corneal wounds. Finally, the presence of insulin receptors on the cornea and lacrimal gland suggests that insulin may contribute to corneal wound healing.
Few case studies describe the use of topical insulin in the absence of other concurrent treatments for neurotrophic keratitis.
Objectives: Through use of topical insulin, promotion of corneal healing in cases where conventional methods have failed. These include topical antibiotics, preservative free artificial tears, and bandage contact lens for at least 2 weeks. This study will evaluate topical insulin as a salvage treatment in patients who otherwise would require tarsorrhaphy.
Research Method: Patients will be recruited in Vancouver, Edmonton, Toronto, Ottawa, Halifax, and Montreal. Patients with neurotrophic corneal ulcers will be identified through the Ophthalmology on call resident clinics in each location and directly referred to a physician in their city who is participating in this study. At least 12 patients will be enrolled in each group (as per power calculation).
Baseline demographic information will be collected (age, gender, medical comorbidities, ocular comorbidities, current medications, and previous and current eyedrops). Baseline ocular examination will consist of a complete ophthalmologic exam, including visual acuity, intraocular pressure, dilated fundus exam or BScan imaging, corneal sensation, eyelid measurements (palpebral fissure, presence of entropion or ectropion, and lagophthalmos), and anterior segment exam and photography. Corneal sensation will be measured in group quadrants and centrally and quantified with cochet bonnet esthesiometry.
Patients will be randomized to one of two groups: Permanent medial tarsorrhaphy or topical insulin drops.
Patients will stop all other topical medication before commencing use of insulin eyedrops. Topical insulin will be compounded under sterile conditions at a local pharmacy at a concentration of 25 IU / ml in sterile balanced saline solution (0.9%). Topical insulin will be administered four times per day to the affected eye.
Patients will be followed up every 3 days after initiation of therapy, or as needed. Each follow up visit will include an ophthalmologic exam with repeat measurements of the epithelial defect, visual acuity, IOP, and anterior segment exam.
The primary outcome will be time to re-epithelialization of neurotrophic ulcer, defined as <0.5mm of remaining epithelial defect. There will also be an evaluation of the percentage of patients healed at each follow up time point. Subgroup analysis will analyze time to re-epithelialization in patients with diabetes separate from patients without diabetes.
The trial will be terminated early if the patients should develop adverse side effects, including allergy, worsening of symptoms, infection, or worsening of keratitis.
Plan for Data Analysis: Statistical analysis to determine the rate of improvement of neurotrophic keratitis by photograph analysis, corneal sensation in four quadrants and centrally, and visual acuity testing.
- Conditions
- Neurotrophic Keratitis
- Being tested
- Insulin, Tarsorrhaphy
- Keywords
- topical insulin, neurotrophic keratopathy, neurotrophic keratitis, tarsorrhaphy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
see arm description
TarsorrhaphyProcedure or surgery
see arm description
| Study group | Role | What they receive |
|---|---|---|
| Topical insulin | Experimental | Topical insulin (Humulin R) will be compounded under sterile conditions at a local pharmacy at a concentration of 25 IU / ml in sterile balanced saline solution (0.9%). Topical insulin will be administered four times per day to the affected eye. A bottle of topical insulin can be used for 14 days. Any remaining topical insulin will be discarded as waste after 14 days. Receives: Drug: Insulin |
| Tarsorrhaphy | Active comparator | Patients in this group will receive a temporary, central tarsorrhaphy and will not use additional eye drops. Receives: Procedure: Tarsorrhaphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to re-epithelialization of neurotrophic ulcer
Time taken for re-epithelialization of the neurotrophic ulcer which will be defined as <0.5 mm of the remaining epithelial defect
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start1 Jun 2022
- Primary completion18 Oct 2023
- Study completion18 Oct 2023
Why it stopped: Study never commenced due to logistical issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Neurotrophic KeratitisStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a randomized controlled trial for the treatment of neurotrophic keratitis. Topical insulin drops will be compared to the current gold standard treatment temporary tarsorrhaphy. Patients will be recruited in Vancouver, Edmonton, Toronto, Montreal, and Halifax. Patients with neurotrophic corneal ulcers will be identified through the Ophthalmology on call resident clinics in each location. They will be directly referred to a physician in their city who is participating in this study. At least 12 patients will be enrolled in each group (as per power calculation): topical insulin drops or tarsorrhaphy.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher J Rudnisky, MD MPH, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321251
- Sponsor's protocol ID
- Pro00107280
- Status last verified
- Feb 2024
- First submitted
- 1 Apr 2022
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Galvis V, Nino CA, Tello A, Grice JM, Gomez MA. Topical insulin in neurotrophic keratopathy after resection of acoustic neuroma. Arch Soc Esp Oftalmol (Engl Ed). 2019 Feb;94(2):100-104. doi: 10.1016/j.oftal.2018.06.003. Epub 2018 Jul 17. English, Spanish.
PubMed 30025986Bastion ML, Ling KP. Topical insulin for healing of diabetic epithelial defects?: A retrospective review of corneal debridement during vitreoretinal surgery in Malaysian patients. Med J Malaysia. 2013 Jun;68(3):208-16.
PubMed 23749008Fai S, Ahem A, Mustapha M, Mohd Noh UK, Bastion MC. Randomized Controlled Trial of Topical Insulin for Healing Corneal Epithelial Defects Induced During Vitreoretinal Surgery in Diabetics. Asia Pac J Ophthalmol (Phila). 2017 Sep-Oct;6(5):418-424. doi: 10.22608/APO.201780. Epub 2017 Aug 22.
PubMed 28828764Tong CM, Iovieno A, Yeung SN. Topical insulin for neurotrophic corneal ulcers. Can J Ophthalmol. 2020 Oct;55(5):e170-e172. doi: 10.1016/j.jcjo.2020.04.001. Epub 2020 May 13. No abstract available.
PubMed 32416928Diaz-Valle D, Burgos-Blasco B, Gegundez-Fernandez JA, Garcia-Caride S, Puebla-Garcia V, Pena-Urbina P, Benitez-Del-Castillo JM. Topical insulin for refractory persistent corneal epithelial defects. Eur J Ophthalmol. 2021 Sep;31(5):2280-2286. doi: 10.1177/1120672120958307. Epub 2020 Sep 21.
PubMed 32951459Wang 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 28742619
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Insulin Drops for the Treatment of Neurotrophic Keratopathy.
- ClinicalTrials.gov ID
- NCT05321251
- Acronym / sponsor ID
- Pro00107280
- Conditions
- Neurotrophic Keratitis
- Keywords
- topical insulin, neurotrophic keratopathy, neurotrophic keratitis, tarsorrhaphy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never commenced due to logistical issues.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 18 Oct 2023 (actual)
- Study completion
- 18 Oct 2023 (actual)
- First posted
- 11 Apr 2022 (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.
Many diseases can affect corneal nerves. Corneas that lack normal sensation are considered neurotrophic. Neurotrophic corneas are predisposed to persistent epithelial defects, recurrent erosions, and corneal ulcers. These can lead to a variety of complications, from subjective pain, discomfort, and blurry vision, to corneal perforation and endophthalmitis. Neurotrophic corneas and the persistent epithelial defects associated with them can be very difficult to treat. Non-invasive measures include topical drops (artificial tears, antibiotics, or steroids), bandage contact lens, and punctal plugs. More invasive surgical treatments include membrane grafts, tarsorrhaphy, and keratoplasty. Despite these treatments, many neurotrophic corneas still do not heal. This study aims to test the efficacy of topical insulin in the treatment of neurotrophic keratopathy.
Detailed description
Purpose: To trial topical insulin drops to promote healing in neurotrophic keratitis that has been refractory to conventional management versus tarsorrhaphy.
Hypothesis: Topical insulin might promote re-epithelialization in the setting of neurotrophic keratitis (Stage 2 or 3) with persistent epithelial defect refractory to conventional treatments and be a non-inferior treatment to tarsorrhaphy.
Justification: Several experiments support the use of insulin for the promotion of corneal epithelial healing. In vitro experiments with immortalized corneal epithelial cells suggest that insulin improves epithelial cell migration. A rabbit model showed improvement in corneal hypoesthesia after topical insulin exposure. These results suggest that early hypoesthesia may be reversible, and thereby improve epithelial wound healing. Another rabbit model showed that topical insulin might alter the corneal surface by increasing the tensile strength of corneal wounds. Finally, the presence of insulin receptors on the cornea and lacrimal gland suggests that insulin may contribute to corneal wound healing.
Few case studies describe the use of topical insulin in the absence of other concurrent treatments for neurotrophic keratitis.
Objectives: Through use of topical insulin, promotion of corneal healing in cases where conventional methods have failed. These include topical antibiotics, preservative free artificial tears, and bandage contact lens for at least 2 weeks. This study will evaluate topical insulin as a salvage treatment in patients who otherwise would require tarsorrhaphy.
Research Method: Patients will be recruited in Vancouver, Edmonton, Toronto, Ottawa, Halifax, and Montreal. Patients with neurotrophic corneal ulcers will be identified through the Ophthalmology on call resident clinics in each location and directly referred to a physician in their city who is participating in this study. At least 12 patients will be enrolled in each group (as per power calculation).
Baseline demographic information will be collected (age, gender, medical comorbidities, ocular comorbidities, current medications, and previous and current eyedrops). Baseline ocular examination will consist of a complete ophthalmologic exam, including visual acuity, intraocular pressure, dilated fundus exam or BScan imaging, corneal sensation, eyelid measurements (palpebral fissure, presence of entropion or ectropion, and lagophthalmos), and anterior segment exam and photography. Corneal sensation will be measured in group quadrants and centrally and quantified with cochet bonnet esthesiometry.
Patients will be randomized to one of two groups: Permanent medial tarsorrhaphy or topical insulin drops.
Patients will stop all other topical medication before commencing use of insulin eyedrops. Topical insulin will be compounded under sterile conditions at a local pharmacy at a concentration of 25 IU / ml in sterile balanced saline solution (0.9%). Topical insulin will be administered four times per day to the affected eye.
Patients will be followed up every 3 days after initiation of therapy, or as needed. Each follow up visit will include an ophthalmologic exam with repeat measurements of the epithelial defect, visual acuity, IOP, and anterior segment exam.
The primary outcome will be time to re-epithelialization of neurotrophic ulcer, defined as <0.5mm of remaining epithelial defect. There will also be an evaluation of the percentage of patients healed at each follow up time point. Subgroup analysis will analyze time to re-epithelialization in patients with diabetes separate from patients without diabetes.
The trial will be terminated early if the patients should develop adverse side effects, including allergy, worsening of symptoms, infection, or worsening of keratitis.
Plan for Data Analysis: Statistical analysis to determine the rate of improvement of neurotrophic keratitis by photograph analysis, corneal sensation in four quadrants and centrally, and visual acuity testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This will be a randomized controlled trial for the treatment of neurotrophic keratitis. Topical insulin drops will be compared to the current gold standard treatment temporary tarsorrhaphy. Patients will be recruited in Vancouver, Edmonton, Toronto, Montreal, and Halifax. Patients with neurotrophic corneal ulcers will be identified through the Ophthalmology on call resident clinics in each location. They will be directly referred to a physician in their city who is participating in this study. At least 12 patients will be enrolled in each group (as per power calculation): topical insulin drops or tarsorrhaphy.
| Arm | Type | Receives |
|---|---|---|
| Topical insulin | Experimental | Drug: InsulinTopical insulin (Humulin R) will be compounded under sterile conditions at a local pharmacy at a concentration of 25 IU / ml in sterile balanced saline solution (0.9%). Topical insulin will be administered four times per day to the affected eye. A bottle of topical insulin can be used for 14 days. Any remaining topical insulin will be discarded as waste after 14 days. |
| Tarsorrhaphy | Active comparator | Procedure: TarsorrhaphyPatients in this group will receive a temporary, central tarsorrhaphy and will not use additional eye drops. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of neurotrophic keratitis with persistent epithelial defect that has been refractory to conventional treatments for at least 2 weeks
- 18 years or older
- Able to provide informed consent
- Failed other conventional treatments for neurotrophic keratitis
- Understanding and accepting of use of topical insulin alone
Key exclusion criteria (6 listed)
- Less than 18 years old
- Pregnant or breastfeeding women
- Unable to provide informed consent
- Unable to comply with tests/follow-up
- Lid function abnormalities (e.g., lagophthalmos, entropion, ectropion, or abnormal orbicularis function from cranial nerve 7 palsy or Bell's palsy)
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 |
|---|---|---|
| Insulinsee arm description | Drug | Topical insulin |
| Tarsorrhaphysee arm description | Procedure or surgery | Tarsorrhaphy |
Primary outcome
Time to re-epithelialization of neurotrophic ulcer
Time frame: 3 months
Time taken for re-epithelialization of the neurotrophic ulcer which will be defined as <0.5 mm of the remaining epithelial defect
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Background: PubMed 30025986Galvis V, Nino CA, Tello A, Grice JM, Gomez MA. Topical insulin in neurotrophic keratopathy after resection of acoustic neuroma. Arch Soc Esp Oftalmol (Engl Ed). 2019 Feb;94(2):100-104. doi: 10.1016/j.oftal.2018.06.003. Epub 2018 Jul 17. English, Spanish.
- Background: PubMed 23749008Bastion ML, Ling KP. Topical insulin for healing of diabetic epithelial defects?: A retrospective review of corneal debridement during vitreoretinal surgery in Malaysian patients. Med J Malaysia. 2013 Jun;68(3):208-16.
- Background: PubMed 28828764Fai S, Ahem A, Mustapha M, Mohd Noh UK, Bastion MC. Randomized Controlled Trial of Topical Insulin for Healing Corneal Epithelial Defects Induced During Vitreoretinal Surgery in Diabetics. Asia Pac J Ophthalmol (Phila). 2017 Sep-Oct;6(5):418-424. doi: 10.22608/APO.201780. Epub 2017 Aug 22.
- Background: PubMed 32416928Tong CM, Iovieno A, Yeung SN. Topical insulin for neurotrophic corneal ulcers. Can J Ophthalmol. 2020 Oct;55(5):e170-e172. doi: 10.1016/j.jcjo.2020.04.001. Epub 2020 May 13. No abstract available.
- Background: PubMed 32951459Diaz-Valle D, Burgos-Blasco B, Gegundez-Fernandez JA, Garcia-Caride S, Puebla-Garcia V, Pena-Urbina P, Benitez-Del-Castillo JM. Topical insulin for refractory persistent corneal epithelial defects. Eur J Ophthalmol. 2021 Sep;31(5):2280-2286. doi: 10.1177/1120672120958307. Epub 2020 Sep 21.
- Results publication: 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.
- 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.
Christopher J Rudnisky, MD MPH principal investigator
University of Alberta
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Insulin and Tarsorrhaphy in people with Neurotrophic Keratitis, run by University of Alberta at 6 sites in Canada.
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 5 inclusion and 6 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: withdrawn, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Time to re-epithelialization of neurotrophic ulcer (time frame: 3 months). 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 NCT05321251, which also lists 6 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 5 Feb 2024.