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

Dry Eye Clinical Trial

Official title:

Safety and Efficacy of Intracanalicular Dexamethasone Insert Compared to Loteprednol Etabonate Ophthalmic Gel 0.38% in Patients With Keratoconus Wearing Gas Permeable Contact Lenses Who Have Been Diagnosed With Allergic Conjunctivitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04418999
• Other study ID #: 19027
• Status: Completed
• Phase: Early Phase 1
• Start date: September 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2022
• Source: Illinois College of Optometry
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Allergy
• Dry Eye
• Keratoconus

Intervention

Drug:
• dexamethasone ophthalmic insert 0.4 mg, for intracanalicular use
Experimental
• Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly
Active Comparator

Locations

Country	Name	City	State
United States	Illinois Eye Institute	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Illinois College of Optometry

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the effect of dexamethasone intracanalicular insert on patients with keratoconus who also have allergies	For patients with keratoconus who wear contact lenses and suffer with allergies OSDI questionnaire will be taken, grading of hyperemia, papillary reaction, corneal staining, IOP will be taken at each visit	90 days
Primary	To determine the effect of dexamethasone intracanalicular insert on patients with keratoconus who also have dry eye	For patients with keratoconus who wear contact lenses and suffer with allergies OSDI questionnaire will be taken, grading of hyperemia, papillary reaction, corneal staining, and IOP will be taken at each visit	90 days