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

Part of paid clinical trials in Sewickley, Pennsylvania.

Sponsor
Pittsburgh Research Institute
Study ID
NCT07490535
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Dry Eye Syndrome (DES)
  • Ocular Surface Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • (Xiidra®) Lifitegrast Ophthalmic Solution 5.0% — DRUG
    30 DED subjects will receive (Xiidra®) lifitegrast ophthalmic solution 5.0%

Study Details

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.

Key Dates

Start date
Mar 31, 2026
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: DED subjects treated with (Xiidra®) lifitegrast ophthalmic solution 5.0%
    30 DED subjects will receive (Xiidra®) lifitegrast ophthalmic solution 5.0%
  • No Intervention: Non-DED, non-treatment arm
    6 non-DED, non-treatment subjects (not receiving Xiidra® or placebo)

Primary Outcome Measure

Change in proteomic expression of tear fluid biomarkers [ Time Frame: 84 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Pittsburgh Research InstituteSewickleyPennsylvania15143
Leanne T Labriola, DO, MBA
[email protected]
412-224-6334
Jeremy M Jones, BS
[email protected]
412-224-6334
Leanne T Labriola, DO, MBA (PRINCIPAL_INVESTIGATOR)

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