Xiidra vs. Xiidra + Dextenza Treatment for Dry Eye Disease

• Status: Recruiting
• Trial end date: 2021-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert in patients with dry eye who are beginning treatment with Xiidra (lifitegrast ophthalmic solution) to reduce the signs and symptoms of dry eye disease.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eye Surgeons of Indiana
• Collaborator: Ocular Therapeutix, Inc.
• Treatments: Dexamethasone; Lifitegrast; Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

A patient's study eye must meet the following criteria to be eligible for inclusion in the study:

• 18 years of age or older

• Signs and symptoms of DED

• 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

Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from the study:

• 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