NCT07490535

This is a Single Center, Open-label Prospective Study to Evaluate the Effect of Xiidra® (Lifitegrast Ophthalmic Solution 5.0%) on Tear Film Biomarkers in Dry Eye

Single-Center, Open-Label Trial to Evaluate the Effect of Lifitegrast Ophthalmic Solution 5.0% on Tear Film Biomarkers in Dry Eye Disease

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Pittsburgh Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Ocular Surface Disease
• Dry Eye Syndrome (DES)

Interventions

Type	Name	Description
DRUG	(Xiidra®) Lifitegrast Ophthalmic Solution 5.0%	30 DED subjects will receive (Xiidra®) lifitegrast ophthalmic solution 5.0%

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-09-01
• Completion: 2026-11-01
• First posted: 2026-03-24
• Last updated: 2026-03-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study