About this trial
This is a single-center prospective open-label, clinical trial to explore proteomic expression of tear fluid biomarkers in patients with dry eye treated with Lifitegrast.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
At least 18 years of age or older at time of screening
Ability to understand and provide informed consent
Subject reported 6-month history of DED in both eyes
No use of ophthalmic drops other than lifitegrast within 2 hours of tear fluid collection to minimize interference with baseline biomarker levels
Disqualifiers
Have a known hypersensitivity or contraindication to the product or their components.
Active ocular infection within the last 30 days.
Any ocular surgical procedure within the last 6 months.
Any subject who has previously tried and failed a course of lifitegrast.
Trial design
Parallel
Treatments tested in this trial
(Xiidra®) Lifitegrast Ophthalmic Solution 5.0%
Drug30 DED subjects will receive (Xiidra®) lifitegrast ophthalmic solution 5.0%
Treatment groups
Trial outcomes
Primary outcomes
Change in proteomic expression of tear fluid biomarkers
Change from baseline (Day 0) in the proteomic expression of tear fluid biomarkers, as measured by high pressure liquid chromatography mass spectrometry, at Day 84 days in subjects with dry eye disease treated with Xiidra® (Lifitegrast Ophthalmic Solution 5.0%).
Sponsors and contacts
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Pittsburgh Research Institute
Lead sponsor
Bausch & Lomb Incorporated
Collaborator
This trial is not recruiting at the moment. You can still explore other options: