Early Phase 1
N=36
Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus
Keratoconus · Dry Eye · Allergy
Bottom Line
View on ClinicalTrials.gov: NCT04418999 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus Who Also Have Allergies — 1.67; 2 papillary grade
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- dexamethasone ophthalmic insert 0.4 mg, for intracanalicular use (Drug); Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Illinois College of Optometry
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus Who Also Have Allergies |
1.67; 2 | — |
| PRIMARY Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus Who Also Have Elevated Osmolarity |
297.8; 304.5 | — |
| PRIMARY Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus and Intraocular Pressure |
14.7; 15.1 | — |
| PRIMARY Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus and Dry Eye |
3.4; 3.6; 5.0; 5.2 | — |
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%?
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- Bilateral Keratoconus
- Bilateral RGP contact lenses
- Bilateral allergic conjunctivitis as determined by the Papillae Efron Scale score of at least 1 and symptoms of itching
- Bilateral underlying dry eye disease as determined by the NEI Fluorescein Staining Scale score of at least 1 and a TBUT of less than 10 and must correlate with dryness on OSDI
Exclusion Criteria
- Patients under the age of 18.
- Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
- Active infectious systemic disease
- Active infectious ocular or extraocular disease
- Obstructed nasolacrimal duct in the study eye(s)
- Hypersensitivity to dexamethasone
- Patients being treated with immunomodulating agents in the study eye(s)
- Patients being treated with immunosuppressants and/or oral steroids Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
Data sourced from ClinicalTrials.gov (NCT04418999). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.