This is a Single Center, Open-label Prospective Study to Evaluate the Effect of Xiidra® (Lifitegr… (NCT07490535) | Clinical Trial Compass
Not Yet RecruitingPhase 4
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
United States36 participantsStarted 2026-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. Willingness to comply with follow-up schedule and required visits
. Corneal fluorescein staining score of inferior 1/3rd of cornea ≥ 2
. EDS ≥40 (0-100-point VAS, both eyes) at Day 0
. Schirmer ≥ 5 and ≤ 10 (without anesthesia)
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is measuring changes in tear fluid biomarkers rather than just tracking symptoms, what does that mean in terms of what I'd personally gain from joining versus simply starting Xiidra on my own through a regular prescription?
2This study is listed as 'not yet recruiting' — how long do you think it might be before it actually opens, and is it worth waiting for it or should we look at starting treatment now?
3Because this is a Phase 4 study, Xiidra is already FDA-approved — does that mean we already have good safety data, and is there any difference in how I'd be monitored compared to just being prescribed it outside of a trial?
4The study involves collecting tear fluid samples to measure proteins — can you walk me through exactly how often I'd need to come in, what those sample collections involve, and whether that level of commitment is realistic for my situation?
5Since this is a single-center study, where is it being conducted, and if it's not near me, is there a standard-of-care option with Xiidra that would make more sense given the travel involved?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in proteomic expression of tear fluid biomarkers
. Any subject who has previously tried and failed a course of lifitegrast.
. Unwilling to discontinue contact lens use for the duration of the study.
. Any female of childbearing potential (FOCBP) who is unwilling to agree to: a) Have a urine pregnancy testing performed at Baseline (Day 0) b) Use at least 1 medically acceptable form of birth control for at least 14 days prior to the first dose of study drug, throughout the study duration, and for 1 month after the last dose of investigational drug. NOTE: FOCBP include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) NOTE: Acceptable forms of birth control include:
. Any male who is unwilling to agree to use at least 1 medically acceptable form of birth control with female partner (FOCBP) who also is not using an acceptable form of birth control (as described above). NOTE: Acceptable forms of birth control include: • True abstinence (when this is in line with the preferred and usual lifestyle of the subject), or • Vasectomy at least 3 months prior to the first dose of study drug. Without a vasectomy, must use condoms with spermicidal foam, gel, film, cream, suppository at least 14 days prior to the first dose of investigational drug and throughout the study duration, and for 1 month after the last dose of the investigational drug.