New eye drop study uses High-Tech microscope to fight dry eye
NCT ID NCT07560735
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests lifitegrast eye drops (Xiidra) in 30 adults with dry eye disease. Researchers will use a special microscope to see if the drops reduce immune cells on the eye surface. The goal is to ease dry eye symptoms and understand how the treatment works.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1\. Subject can read, understand and sign an informed consent letter. 2. Provision of signed and dated informed consent form and HIPAA authorization. 3. Stated willingness to comply with all study procedures and availability for the duration of the study 4. Male or female at least 18 years of age at the time of enrollment 5. Minimum corneal staining of ≥2 or greater according to the NEI grading scale in the lower corneal subregion. Normal eyelids and corneal anatomy 7. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of study drug administration 8. For males of reproductive potential: should be able to agree to use at least 1 medically acceptable form of birth control with female partner (FOCBP) 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 4 weeks after the last dose of the investigational drug. • Or the female partner of the male investigational subject, must comply with the previous points. 9\. Are postmenopausal (no menstrual cycle for at least one year prior to Visit 1) or have undergone bilateral tubal ligation, hysterectomy, hysterectomy with uni- or bilateral oophorectomy, or bilateral oophorectomy for 1 year prior to study start. 10\. Best corrected visual acuity of 0.7 logMAR or better (Snellen equivalent score of 20/100 or better) in each eye at day -14 (Visit 1) and Day 0 (Visit 2) 11. Subject-reported history of dry eye for at least 6 months. 12. Schirmer Tear Test (without anesthesia) ≥1mm and ≤10mm at baseline 13. EDS score of ≥40 (0-100-point VAS, both eyes) value is an average at screening and baseline. Exclusion Criteria: * 1\. Have a known hypersensitivity or contraindication to the product or their components. Unwilling to discontinue contact lens use for the duration of the study 3. Pregnancy or lactation 4. Have used topical or nasal vasoconstrictors within 14 days prior to screening or unable to refrain from the same during study period 5. Subjects that use topical steroids, systemic immunosuppressive agents including oral corticosteroids, antihistamines, mast cell stabilizers or glaucoma medications. 6\. Subjects unwilling to abstain from eyelash growth products containing prostaglandins for the duration of the trial. 7\. Subjects who had ocular surgery within the past 1 year prior to Visit 1. 8. Febrile illness within one week. 9. Active or history of infectious keratitis; any other ocular infection within the last 30 days 10. Have serious or severe disease or uncontrolled medical condition that in the judgement of the investigator could confound study assessments or limit compliance. 11\. Use of new prescription eyedrop within 30 days of screening 12. Change in systemic medication within 30 days of screening 13. Any subject who has previously tried and failed a course of lifitegrast. 14. Subjects with secondary Sjogren's syndrome (ex. Rheumatoid arthritis, systemic lupus, erythematosus) or other autoimmune disease (ex: multiple sclerosis, inflammatory bowel disease) are eligible for enrollment consideration provided the subject met all other inclusion and exclusion criteria, AND, were not in a medical state in the opinion of the principle investigator that could have interfered with the study parameters, were not taking systemic/ocular steroids and were not immunodeficient/immunosuppressed (ex: receiving systemic immunomodulating or immunosuppressive drugs to manage their baseline medical state.)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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West Tennesse Eye Care dba Toyos Clinic
Nashville, Tennessee, 37215, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- A gel plug for tear ducts may stop post-surgery dry eye
- Can a thymosin beta 4 eye drop soothe dry eye?
- Insulin-spiked eye drops may ease stubborn dry eye in Sjögren's patients
- Can four eye scanners detect how miebo stabilizes tears?