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Hormone Therapy
Topical Insulin Drops for Neurotrophic Keratitis
Phase 2 & 3
Waitlist Available
Led By Christopher J Rudnisky, MD MPH
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Study Summary
This trial will test the efficacy of topical insulin in the treatment of corneal nerve damage, which can lead to a variety of complications including pain, discomfort, and blurry vision.
Who is the study for?
This trial is for adults over 18 with neurotrophic keratitis, a condition where the cornea loses sensation and doesn't heal properly. Participants must have tried other treatments without success and be able to consent to using topical insulin drops.Check my eligibility
What is being tested?
The study tests if topical insulin can help heal the cornea in patients with neurotrophic keratopathy who haven't responded to standard care. It compares this new approach against more invasive procedures like tarsorrhaphy (partially sewing eyelids together).See study design
What are the potential side effects?
Topical insulin might cause eye irritation, discomfort, or allergic reactions. Tarsorrhaphy may lead to altered eyelid appearance, infection at the stitch site, or difficulty fully closing the eyes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to re-epithelialization of neurotrophic ulcer
Side effects data
From 2015 Phase 4 trial • 156 Patients • NCT0200222113%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Femoral neck fracture
1%
Squamous cell carcinoma of the tongue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Topical insulinExperimental Treatment1 Intervention
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.
Group II: TarsorrhaphyActive Control1 Intervention
Patients in this group will receive a temporary, central tarsorrhaphy and will not use additional eye drops.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin
2000
Completed Phase 4
~4280
Find a Location
Who is running the clinical trial?
University of AlbertaLead Sponsor
886 Previous Clinical Trials
384,778 Total Patients Enrolled
Christopher J Rudnisky, MD MPHPrincipal InvestigatorUniversity of Alberta
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have certain eyelid problems, such as difficulty closing your eyes, turning them inward or outward, or weakness in the facial muscles.You have tried other treatments for neurotrophic keratitis, but they haven't worked.You understand and agree to use only topical insulin.You are currently using topical medication, such as topical ganciclovir.You have a type of eye condition called neurotrophic keratitis that has not improved with standard treatments for at least two weeks.You are pregnant or currently breastfeeding.
Research Study Groups:
This trial has the following groups:- Group 1: Tarsorrhaphy
- Group 2: Topical insulin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are we currently looking for new patients to enroll in this trial?
"The clinical trial is actively recruiting participants, as noted on the website clinicaltrials.gov. This study was first posted on 6/1/2022 and was last updated on 7/7/2022; it seeks to enroll 60 individuals across six locations."
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