Status:
TERMINATED
Xiidra vs. Xiidra + Dextenza Treatment for Dry Eye Disease
Lead Sponsor:
Eye Surgeons of Indiana
Collaborating Sponsors:
Ocular Therapeutix, Inc.
Conditions:
Dry Eye Syndromes
Eligibility:
All Genders
Phase:
PHASE4
Brief 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 soluti...
Detailed Description
This prospective study will use a fellow-eye design for 20 participants, 40 eyes. All eyes will receive bilateral Xiidra. The most symptomatic eye will be selected to receive DEXTENZA® insertion on th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2022
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04413253
Start Date
August 1 2020
End Date
April 11 2022
Last Update
April 18 2022
Active Locations (1)
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1
Eye Surgeons of Indiana
Indianapolis, Indiana, United States, 46040