Comparing Treatment of Dry Eye With Intracanalicular Dexamethasone, Restasis, and/or Lotemax

Completed · Phase 4

Conditions studied: Dry Eye

In brief

This 6 month study seeks to compare the use of Intracanalicular Dexamethasone in conjunction with Restasis (cyclosporine ophthalmic emulsion) for the treatment of signs and symptoms of dry eye disease as compared to Restasis with Lotemax (loteprednol etabonate ophthalmic suspension 0.5%) and Restasis monotherapy.

Key facts

Study ID

NCT04555694

Run by

Thomas Chester, OD

People needed

30

Starts

2020-10-01

Expected to finish

2022-02-16

Last updated by the study team

2023-10-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18 years of age or older
• Signs and symptoms of Dry Eye Disease
• Consent to treat with topical immunomodulator
• Willing and able to comply with clinic visits and study related procedures
• Willing and able to sign the informed consent form

You may not qualify if…

• 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
• Altered nasolacrimal flow of either acquired, induced, or congenital origin
• Hypersensitivity to dexamethasone
• Patients who have been on topical immunomodulating agents in the previous 3 months to their baseline visit
• Patient being treated with either topical, oral, or intravenous immunosuppressive agents, immunomodulating agents, or steroid (including NSAIDS)
• Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

Where it is running

• Cleveland Eye Clinic — Brecksville, Ohio, United States

Full record on ClinicalTrials.gov

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