Ocular Surface DiseasePhase 4NCT07490535
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
A Phase 4 study testing (Xiidra®) Lifitegrast Ophthalmic Solution 5.0% in people with Ocular Surface Disease and Dry Eye Syndrome (DES), run by Pittsburgh Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ocular Surface Disease, Dry Eye Syndrome (DES)
- What is being tested?
- (Xiidra®) Lifitegrast Ophthalmic Solution 5.0%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2026to Nov 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- EDS ≥40 (0-100-point VAS, both eyes) at Day 0
- Schirmer ≥ 5 and ≤ 10 (without anesthesia)
- Best corrected visual acuity (BCVA) of 0.7 logMAR of better (logMAR <0.7; Snellen equivalent score
Who cannot join
- 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.
- 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:
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- 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.
- 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.
- Pregnancy or lactation
- Current or past treatment with prescription drops for dry eye within the last six weeks.
- 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.)
- 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.
- 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)
- At least 18 years of age or older at time of screening
- Ability to understand and provide informed consent
- No use of ophthalmic drops within 2 hours of tear fluid collection to minimize interference with baseline biomarker levels
- Willingness to comply with follow-up schedule and required visits
- No subject reported history of DED
- Schirmer ≥ 10 (without anesthesia)
- 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)
- Active ocular infection within the last 30 days
- Any ocular surgical procedure within the last 6 months
- Unwilling to discontinue contact lens use for the duration of the study
- Pregnancy or lactation
- 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.
- 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.
- History of DED diagnosis
- 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.)
- 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.
- 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.
- Any subject that has punctal occlusion such as permanent/semi-permanent punctal plugs, temporary plugs, punctal cauterization
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Pittsburgh Research Institute
Sewickley, Pennsylvania, 15143
Leanne T Labriola, DO, MBA, 412-224-6334, labriola@pghtrials.com
Jeremy M Jones, BS, 412-224-6334, jeremy@pghtrials.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Ocular Surface Disease, Dry Eye Syndrome (DES)
- Being tested
- (Xiidra®) Lifitegrast Ophthalmic Solution 5.0%
- Keywords
- dry eye disease
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(Xiidra®) Lifitegrast Ophthalmic Solution 5.0%Drug
30 DED subjects will receive (Xiidra®) lifitegrast ophthalmic solution 5.0%
| Study group | Role | What they receive |
|---|---|---|
| DED subjects treated with (Xiidra®) lifitegrast ophthalmic solution 5.0% | Experimental | 30 DED subjects will receive (Xiidra®) lifitegrast ophthalmic solution 5.0% Receives: Drug: (Xiidra®) Lifitegrast Ophthalmic Solution 5.0% |
| Non-DED, non-treatment arm | No intervention | 6 non-DED, non-treatment subjects (not receiving Xiidra® or placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Surface DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This single center, prospective, open label clinical trial will enroll subjects with clinically confirmed dry eye disease (DED), along with six non DED participants who will not receive Xiidra® or placebo. The primary objective of this study phase is to characterize and assess tear fluid biomarkers using comprehensive proteomic methodologies.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pittsburgh Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Responsible party
- Sponsor
- Investigators
- Leanne T Labriola, DO, MBA, Principal investigator, Pittsburgh Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490535
- Sponsor's protocol ID
- BL-MA-RX01-LIFTFBP-1402
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Center, Open-Label Trial to Evaluate the Effect of Lifitegrast Ophthalmic Solution 5.0% on Tear Film Biomarkers in Dry Eye Disease
- ClinicalTrials.gov ID
- NCT07490535
- Acronym / sponsor ID
- BL-MA-RX01-LIFTFBP-1402
- Conditions
- Ocular Surface Disease, Dry Eye Syndrome (DES)
- Keywords
- dry eye disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Pittsburgh Research InstituteUniversity, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Study start
- Mar 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This single center, prospective, open label clinical trial will enroll subjects with clinically confirmed dry eye disease (DED), along with six non DED participants who will not receive Xiidra® or placebo. The primary objective of this study phase is to characterize and assess tear fluid biomarkers using comprehensive proteomic methodologies.
| Arm | Type | Receives |
|---|---|---|
| DED subjects treated with (Xiidra®) lifitegrast ophthalmic solution 5.0% | Experimental | Drug: (Xiidra®) Lifitegrast Ophthalmic Solution 5.0%30 DED subjects will receive (Xiidra®) lifitegrast ophthalmic solution 5.0% |
| Non-DED, non-treatment arm | No intervention | –6 non-DED, non-treatment subjects (not receiving Xiidra® or placebo) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (40 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (Xiidra®) Lifitegrast Ophthalmic Solution 5.0%30 DED subjects will receive (Xiidra®) lifitegrast ophthalmic solution 5.0% | Drug | DED subjects treated with (Xiidra®) lifitegrast ophthalmic solution 5.0% |
Primary outcome
Change in proteomic expression of tear fluid biomarkers
Time frame: 84 days
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%).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leanne T Labriola, DO, MBA principal investigator
Pittsburgh Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing (Xiidra®) Lifitegrast Ophthalmic Solution 5.0% in people with Ocular Surface Disease and Dry Eye Syndrome (DES), run by Pittsburgh Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leanne T Labriola, DO, MBA (412-224-6334, labriola@pghtrials.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in proteomic expression of tear fluid biomarkers (time frame: 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.