Lifitegrast for Dry Eye

Overseen By Jeremy M Jones, BS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Pittsburgh Research Institute

Must be taking: Xiidra

Must not be taking: Prescription dry eye drops

Disqualifiers: Ocular infection, Ocular surgery, Pregnancy, Immunodeficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

Leanne T Labriola, DO, MBA

Principal Investigator

Pittsburgh Research Institute

Are You a Good Fit for This Trial?

Inclusion Criteria

I am currently using Xiidra eye drops.

Willingness to comply with follow-up schedule and required visits

Corneal fluorescein staining score of inferior 1/3rd of cornea ≥ 2

Exclusion Criteria

Pregnancy or lactation

I am not willing to stop wearing contact lenses during the study.

I do not have HIV, hepatitis, immunodeficiency, or a history of organ or bone marrow transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Xiidra® (Lifitegrast Ophthalmic Solution 5.0%) for dry eye disease

12 weeks

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lifitegrast

How Is the Trial Designed?

Group I: DED subjects treated with (Xiidra®) lifitegrast ophthalmic solution 5.0% Experimental Treatment 1 Intervention

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

Group II: Non-DED, non-treatment arm Active Control 1 Intervention

6 non-DED, non-treatment subjects (not receiving Xiidra® or placebo)

Who Is Running the Clinical Trial?

Pittsburgh Research Institute

Lead Sponsor

Bausch & Lomb Incorporated

Industry Sponsor

Trials

263

Recruited

59,400+

Dr. Christina Ackermann

Bausch & Lomb Incorporated

Chief Medical Officer since 2023

MD from Harvard Medical School

Brent Saunders

Bausch & Lomb Incorporated

Chief Executive Officer since 2023

BA from the University of Pittsburgh, JD and MBA from Temple University