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

Single-Center, Open-Label Trial to Evaluate the Effect of Lifitegrast Ophthalmic Solution 5.0% on Tear Film Biomarkers in Dry Eye Disease

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ocular Surface Disease; Dry Eye Syndrome (DES)
• Intervention / Treatment: Drug: (Xiidra®) Lifitegrast Ophthalmic Solution 5.0%

Detailed Description

Approximately 30 subjects with dry eye disease (DED) will receive Xiidra®, while 6 non DED subjects will serve as a non treatment group. The study will evaluate changes in tear fluid biomarker expression using mass spectrometry-based proteomic analysis.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Leanne T Labriola, DO, MBA; Phone Number: 412-224-6334; Email: labriola@pghtrials.com
• Study Contact Backup: Name: Jeremy M Jones, BS; Phone Number: 412-224-6334; Email: jeremy@pghtrials.com

Study Locations

• United States
  • Pennsylvania
    • Sewickley, Pennsylvania, United States, 15143
      • Pittsburgh Research Institute
      • Contact: Leanne T Labriola, DO, MBA; Phone Number: 412-224-6334; Email: labriola@pghtrials.com
      • Contact: Jeremy M Jones, BS; Phone Number: 412-224-6334; Email: jeremy@pghtrials.com
      • Principal Investigator: Leanne T Labriola, DO, MBA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria: DED Subjects receiving Xiidra®

1. At least 18 years of age or older at time of screening
2. Ability to understand and provide informed consent
3. Subject reported 6-month history of DED in both eyes
4. No use of ophthalmic drops other than lifitegrast within 2 hours of tear fluid collection to minimize interference with baseline biomarker levels
5. Willingness to comply with follow-up schedule and required visits
6. Corneal fluorescein staining score of inferior 1/3rd of cornea ≥ 2
7. EDS ≥40 (0-100-point VAS, both eyes) at Day 0
8. Schirmer ≥ 5 and ≤ 10 (without anesthesia)
9. Best corrected visual acuity (BCVA) of 0.7 logMAR of better (logMAR <0.7; Snellen equivalent score

Exclusion Criteria: DED Subjects receiving Xiidra®

1. Have a known hypersensitivity or contraindication to the product or their components.
2. Active ocular infection within the last 30 days.
3. Any ocular surgical procedure within the last 6 months.
4. Any subject who has previously tried and failed a course of lifitegrast.
5. Unwilling to discontinue contact lens use for the duration of the study.

6. 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:

   • Mechanical (spermicide in conjunction with a barrier such as a diaphragm or condom)
   • Hormonal contraceptive (oral, injectable, implantable, or transdermal)
   • Intrauterine device, or
   • Surgical sterilization of male partner at least 3 months prior to the first dose of investigational drug NOTE: For non-sexually active female subjects, abstinence may be regarded as an adequate method of birth control when this is in line with the preferred and usual lifestyle of the subject; however, if the subject becomes sexually active during the trial, she must agree to use adequate birth control as defined above for the remainder of the trial.
7. 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.
8. Pregnancy or lactation
9. Current or past treatment with prescription drops for dry eye within the last six weeks.
10. Any ocular condition that, in the opinion of the investigator, could affect study parameters including, but not limited to, lid margin disorders (e.g. Blepharitis, staphylococcal, demodex etc.)
11. Any known history of immunodeficiency disorder, human immunodeficiency virus, hepatitis B or C, evidence of acute active hepatitis A (antihepatitis A virus immunoglobulin M), or organ or bone marrow transplant.
12. Any known history of alcohol and/or drug abuse within 12 months prior to the screening visit that, in the opinion of the investigator, may have interfered with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject.

Inclusion Criteria: (Non-DED) subjects not receiving Xiidra® (non-treatment arm)

1. At least 18 years of age or older at time of screening
2. Ability to understand and provide informed consent
3. No use of ophthalmic drops within 2 hours of tear fluid collection to minimize interference with baseline biomarker levels
4. Willingness to comply with follow-up schedule and required visits
5. No subject reported history of DED
6. Schirmer ≥ 10 (without anesthesia)
7. Best corrected visual acuity (BCVA) of 0.7 logMAR of better (logMAR <0.7; Snellen equivalent score of 20/100 or better) in each eye at the screening visit (Day 0).

Exclusion Criteria: (Non-DED) subjects not receiving Xiidra® (non-treatment arm)

1. Active ocular infection within the last 30 days
2. Any ocular surgical procedure within the last 6 months
3. Unwilling to discontinue contact lens use for the duration of the study
4. Pregnancy or lactation

5. 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:

   • Mechanical (spermicide in conjunction with a barrier such as a diaphragm or condom)
   • Hormonal contraceptive (oral, injectable, implantable, or transdermal)
   • Intrauterine device, or
   • Surgical sterilization of male partner at least 3 months prior to the first dose of investigational drug NOTE: For non-sexually active female subjects, abstinence may be regarded as an adequate method of birth control when this is in line with the preferred and usual lifestyle of the subject; however, if the subject becomes sexually active during the trial, she must agree to use adequate birth control as defined above for the remainder of the trial.
6. 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.
7. History of DED diagnosis
8. Any ocular condition that, in the opinion of the investigator, could affect study parameters including, but not limited to, lid margin disorders (eg. Blepharitis, staphylococcal, demodex etc.)
9. Any known history of immunodeficiency disorder, human immunodeficiency virus, hepatitis B or C, evidence of acute active hepatitis A (antihepatitis A virus immunoglobulin M), or organ or bone marrow transplant.
10. Any known history of alcohol and/or drug abuse within 12 months prior to the screening visit that, in the opinion of the investigator, may have interfered with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject.
11. Any subject that has punctal occlusion such as permanent/semi-permanent punctal plugs, temporary plugs, punctal cauterization

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DED subjects treated with (Xiidra®) lifitegrast ophthalmic solution 5.0%; 30 DED subjects will receive (Xiidra®) lifitegrast ophthalmic solution 5.0%	Drug: (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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%).	84 days

Collaborators and Investigators

• Sponsor: Pittsburgh Research Institute
• Collaborators: Bausch & Lomb Incorporated
• Investigators: Principal Investigator: Leanne T Labriola, DO, MBA, Pittsburgh Research Institute

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: dry eye disease
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes; lifitegrast
• Other Study ID Numbers: BL-MA-RX01-LIFTFBP-1402

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes