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 range18 Years
SexALL
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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.
✕. Any subject who has previously tried and failed a course of lifitegrast.
✕. Unwilling to discontinue contact lens use for the duration of the study.
✕
What they're measuring
1
Change in proteomic expression of tear fluid biomarkers
. 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.