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Completed
NCT04413279
Lipiflow Treatment Alone vs. Lipiflow + Dextenza Treatment for Dry Eye Disease
Conditions: Dry Eye Syndromes
Sex: All
Healthy volunteers: No
Phase: PHASE4
Enrollment: 20
Sponsor: Eye Surgeons of Indiana
Location: Eye Surgeons of Indiana Indianapolis Indiana
Summary
To evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert in evaporative dry eye disease (DED) patients with meibomian gland disfunction (MGD) and underlying inflammation undergoing LipiFlow Thermal Pulsation.
Eligibility 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
* Evaporative DED with MGD and clinically significant inflammation
* 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
* Patient being treated with either topical, oral, or intravenous steroids
* Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
Source: ClinicalTrials.gov (NCT04413279). StuddyBuddy aggregates publicly available trial information.