Topical Insulin Drops for the Treatment of Neurotrophic Keratopathy.

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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

Locations
Other Locations
Canada
University of Alberta
Recruiting
Edmonton
Dalhousie University
Not yet recruiting
Halifax
University of Montreal
Not yet recruiting
Montréal
Precision Cornea Clinic
Not yet recruiting
Ottawa
University of Toronto
Not yet recruiting
Toronto
University of British Columbia
Not yet recruiting
Vancouver
Contact Information
Primary
Maya Tong, MD
mayatong@ualberta.ca
780 735 5013
Backup
Christopher J Rudnisky, MD MPH
crudnisk@ualberta.ca
780 735 5013
Time Frame
Start Date: June 1, 2022
Estimated Completion Date: January 2023
Participants
Target number of participants: 60
Treatments
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.
Active Comparator: Tarsorrhaphy
Patients in this group will receive a temporary, central tarsorrhaphy and will not use additional eye drops.
Authors
Christopher J Rudnisky
Sponsors
Leads: University of Alberta

This content was sourced from clinicaltrials.gov