We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Topical Insulin Drops for the Treatment of Neurotrophic Keratopathy.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05321251
Recruitment Status : Recruiting
First Posted : April 11, 2022
Last Update Posted : February 3, 2023
Information provided by (Responsible Party):
University of Alberta

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Neurotrophic Keratitis Drug: Insulin Procedure: Tarsorrhaphy Phase 2 Phase 3

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Masking Description: Treatment will be randomized / assigned randomly, but neither the patients, care providers, or investigators will be masked to treatment once it is being provided.
Primary Purpose: Treatment
Official Title: Topical Insulin Drops for the Treatment of Neurotrophic Keratopathy.
Actual Study Start Date : June 1, 2022
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Topical insulin
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.
Drug: Insulin
see arm description

Active Comparator: Tarsorrhaphy
Patients in this group will receive a temporary, central tarsorrhaphy and will not use additional eye drops.
Procedure: Tarsorrhaphy
see arm description

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05321251

Layout table for location contacts
Contact: Maya Tong, MD 780 735 5013 mayatong@ualberta.ca
Contact: Christopher J Rudnisky, MD MPH 780 735 5013 crudnisk@ualberta.ca

Layout table for location information
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2C8
Contact: Christopher Rudnisky, MD         
Canada, British Columbia
University of British Columbia Not yet recruiting
Vancouver, British Columbia, Canada
Contact: Sonia Yeung, MD         
Canada, Nova Scotia
Dalhousie University Not yet recruiting
Halifax, Nova Scotia, Canada
Contact: Darrell Lewis, MD         
Canada, Ontario
Precision Cornea Clinic Not yet recruiting
Ottawa, Ontario, Canada
Contact: Saama Sabeti, MD         
University of Toronto Not yet recruiting
Toronto, Ontario, Canada
Contact: Clara Chan, MD         
Canada, Quebec
University of Montreal Not yet recruiting
Montréal, Quebec, Canada
Contact: Mona Dagher, MD         
Sponsors and Collaborators
University of Alberta
Layout table for investigator information
Principal Investigator: Christopher J Rudnisky, MD MPH University of Alberta
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT05321251    
Other Study ID Numbers: Pro00107280
First Posted: April 11, 2022    Key Record Dates
Last Update Posted: February 3, 2023
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Alberta:
topical insulin
neurotrophic keratopathy
neurotrophic keratitis
Additional relevant MeSH terms:
Layout table for MeSH terms
Corneal Diseases
Eye Diseases
Hypoglycemic Agents
Physiological Effects of Drugs