Status:
COMPLETED
Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus
Lead Sponsor:
Illinois College of Optometry
Conditions:
Keratoconus
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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...
Detailed Description
This prospective, open-label, single-center, randomized, fellow-eye, investigator-sponsored clinical study seeks to investigate the safety and efficacy of the dexamethasone insert in the treatment of ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04418999
Start Date
September 1 2020
End Date
December 31 2021
Last Update
April 6 2025
Active Locations (1)
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1
Illinois Eye Institute
Chicago, Illinois, United States, 60616