Dry EyePhase 4(IVCM)NCT07560735
Clinical Evaluation of Lifitegrast Ophthalmic Solution 5.0% in Dry Eye Disease Using In Vivo Confocal Microscopy
A Phase 4 study testing Lifitegrast Ophthalmic Solution 5.0% (Xiidra) in people with Dry Eye, run by Toyos Clinic at 1 site in United States.
Trial summary
This is a single center, open label trial to evaluate Lifitegrast Ophthalmic Solution 5.0% in Dry Eye Disease using In Vivo Confocal Microscopy (IVCM Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Lifitegrast Ophthalmic Solution 5.0% (Xiidra)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2026to Mar 2027
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.)
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
West Tennesse Eye Care dba Toyos Clinic
Nashville, Tennessee, 37215
Melissa Toyos, MD, 615-327-4015, mtoyos@toyosclinic.com
Harley Cheney, 615-327-4015, hcheney@toyosclinic.com
About this study
Official title: Clinical Evaluation of Lifitegrast Ophthalmic Solution 5.0% in Dry Eye Disease Using In Vivo Confocal Microscopy (IVCM)
This is a single center, open label trial to evaluate Lifitegrast Ophthalmic Solution 5.0% in Dry Eye Disease using In Vivo Confocal Microscopy (IVCM
Read the detailed description
Approximately 30 subjects with dry eye disease (DED) will be treated with Xiidra® to evaluate the effects of lifitegrast on the ocular surface using in vivo confocal microscopy.
- Conditions
- Dry Eye
- Being tested
- Lifitegrast Ophthalmic Solution 5.0% (Xiidra)
- 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.
Lifitegrast Ophthalmic Solution 5.0% (Xiidra)Drug
30 subjects with DED will receive lifitegrast ophthalmic solution 5.0% (Xiidra)
| Study group | Role | What they receive |
|---|---|---|
| DED subjects treated with lifitegrast ophthalmic solution 5.0% (Xiidra) | Experimental | 30 subjects with DED receiving lifitegrast ophthalmic solution 5.0% (Xiidra) Receives: Drug: Lifitegrast Ophthalmic Solution 5.0% (Xiidra) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in immune cell density in subjects with dry eye disease treated with lifitegrast
Change from baseline (Day 0) immune cell density, as measured by in vivo confocoal microscopy (IVCM), in subjects with dry eye disease treated with Xiidra (Lifitegrast Opthalmic Solution 5.0%), at Day 84.
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 posted1 May 2026
- Study startApr 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This single center, prospective, open label study will enroll 30 subjects with dry eye disease (DED) to evaluate ocular surface tissue responses following treatment with lifitegrast ophthalmic solution 5.0% (Xiidra®). In vivo confocal microscopy will be used to assess immune cell morphology and activity within the corneal stroma and related ocular surface structures.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toyos Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa Toyos, MD, Principal investigator, West Tennessee Eyecare dba Toyos ClinicRolando Toyos, MD, Principal investigator, West Tennessee Eyecare dca Toyos Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560735
- Sponsor's protocol ID
- BL-MA-RX01-LIFIVCM-1401
- Acronym
- (IVCM)
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Lifitegrast Ophthalmic Solution 5.0% in Dry Eye Disease Using In Vivo Confocal Microscopy (IVCM)
- ClinicalTrials.gov ID
- NCT07560735
- Acronym / sponsor ID
- (IVCM) / BL-MA-RX01-LIFIVCM-1401
- Conditions
- Dry Eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Toyos ClinicUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 1 May 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, open label trial to evaluate Lifitegrast Ophthalmic Solution 5.0% in Dry Eye Disease using In Vivo Confocal Microscopy (IVCM
Detailed description
Approximately 30 subjects with dry eye disease (DED) will be treated with Xiidra® to evaluate the effects of lifitegrast on the ocular surface using in vivo confocal microscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This single center, prospective, open label study will enroll 30 subjects with dry eye disease (DED) to evaluate ocular surface tissue responses following treatment with lifitegrast ophthalmic solution 5.0% (Xiidra®). In vivo confocal microscopy will be used to assess immune cell morphology and activity within the corneal stroma and related ocular surface structures.
| Arm | Type | Receives |
|---|---|---|
| DED subjects treated with lifitegrast ophthalmic solution 5.0% (Xiidra) | Experimental | Drug: Lifitegrast Ophthalmic Solution 5.0% (Xiidra)30 subjects with DED receiving lifitegrast ophthalmic solution 5.0% (Xiidra) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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.)
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 |
|---|---|---|
| Lifitegrast Ophthalmic Solution 5.0% (Xiidra)30 subjects with DED will receive lifitegrast ophthalmic solution 5.0% (Xiidra) | Drug | DED subjects treated with lifitegrast ophthalmic solution 5.0% (Xiidra) |
Primary outcome
Change in immune cell density in subjects with dry eye disease treated with lifitegrast
Time frame: 84 days
Change from baseline (Day 0) immune cell density, as measured by in vivo confocoal microscopy (IVCM), in subjects with dry eye disease treated with Xiidra (Lifitegrast Opthalmic Solution 5.0%), at Day 84.
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 1 May 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.
Melissa Toyos, MD principal investigator
West Tennessee Eyecare dba Toyos Clinic
Rolando Toyos, MD principal investigator
West Tennessee Eyecare dca Toyos Clinic
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 Lifitegrast Ophthalmic Solution 5.0% (Xiidra) in people with Dry Eye, run by Toyos Clinic 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 5 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 1 May 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 Melissa Toyos, MD (615-327-4015, mtoyos@toyosclinic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in immune cell density in subjects with dry eye disease treated with lifitegrast (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 1 May 2026.