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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorPittsburgh Research Institute

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • (Xiidra®) Lifitegrast Ophthalmic Solution 5.0%

    Drug

    30 DED subjects will receive (Xiidra®) lifitegrast ophthalmic solution 5.0%

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: DED subjects treated with (Xiidra®) lifitegrast ophthalmic solution 5.0%Experimental treatment 1 intervention
Group B: Non-DED, non-treatment armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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%).

Time frame
84 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pittsburgh Research Institute

Lead sponsor

Bausch & Lomb Incorporated

Collaborator

This trial is not recruiting at the moment. You can still explore other options: