Status:
COMPLETED
Lipiflow Treatment Alone vs. Lipiflow + 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 evaporative dry eye disease (DED) patients with meibomian gland disfunction (MGD) and underl...
Detailed Description
This prospective, open-label, single-center, non-randomized, investigator-sponsored clinical study seeks to investigate the benefit of managing patients with DED secondary to MGD with a sustained rele...
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
- 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
- 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
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04413279
Start Date
August 1 2020
End Date
July 1 2021
Last Update
April 18 2022
Active Locations (1)
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1
Eye Surgeons of Indiana
Indianapolis, Indiana, United States, 46040