Single-Center, Open-Label Trial to Evaluate the Effect of Lifitegrast Ophthalmic Solution 5.0% on Tear Film Biomarkers in Dry Eye Disease
Pittsburgh Research Institute
Summary
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.
Description
Approximately 30 subjects with dry eye disease (DED) will receive Xiidra®, while 6 non DED subjects will serve as a non treatment group. The study will evaluate changes in tear fluid biomarker expression using mass spectrometry-based proteomic analysis.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: DED Subjects receiving Xiidra® 1. At least 18 years of age or older at time of screening 2. Ability to understand and provide informed consent 3. Subject reported 6-month history of DED in both eyes 4. No use of ophthalmic drops other than lifitegrast within 2 hours of tear fluid collection to minimize interference with baseline biomarker levels 5. Willingness to comply with follow-up schedule and required visits 6. Corneal fluorescein staining score of inferior 1/3rd of cornea ≥ 2 7. EDS ≥40 (0-100-point VAS, both eyes) at Day 0 8. Schirmer ≥ 5 and ≤ 10 (without anesthesi…
Interventions
- Drug(Xiidra®) Lifitegrast Ophthalmic Solution 5.0%
30 DED subjects will receive (Xiidra®) lifitegrast ophthalmic solution 5.0%
Location
- Pittsburgh Research InstituteSewickley, Pennsylvania