drugset / Trial / NCT04418999

Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus

NCT04418999

Phase 0 Completed 36 enrolled Illinois College of Optometry
RandomizedCrossoverOpen-labelTreatment

Summary

Drug delivery platforms are an innovative exciting advancement in ophthalmology. They allow patients to eliminate topical medications which are generally associated with lack of compliance, difficulty of use and requiring help from family members. These delivery systems can be applied easily in office, and patients do not have to worry about drop insertion in their post-operative regimen. The results of this research project should help to answer the following question: Does the use of a physician administered intracanalicular dexamethasone insert improve the signs and symptoms of ocular allergy and dry eye disease in KC patients compared to the use of topical loteprednol etabonate ophthalmic gel 0.38%?

Timeline

Start
2020-09-01
Primary completion
2021-12-31
Completion
2021-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 0.4 mg Other
Comparator Loteprednol Etabonate Other / unclassified 0.38 % Topical