Clinical Evaluation of Lifitegrast Ophthalmic Solution 5.0% in Dry Eye Disease Using In Vivo Confocal Microscopy

NCT07560735 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: BL-MA-RX01-LIFIVCM-1401
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• 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.

  84 days

Study Arms (1)

DED subjects treated with lifitegrast ophthalmic solution 5.0% (Xiidra)

EXPERIMENTAL

30 subjects with DED receiving lifitegrast ophthalmic solution 5.0% (Xiidra)

Drug: Lifitegrast Ophthalmic Solution 5.0% (Xiidra)

Interventions

Lifitegrast Ophthalmic Solution 5.0% (Xiidra) DRUG

30 subjects with DED will receive lifitegrast ophthalmic solution 5.0% (Xiidra)

DED subjects treated with lifitegrast ophthalmic solution 5.0% (Xiidra)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. 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.
• \. 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.

You may not qualify if:

• \. 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.
• \. Subjects unwilling to abstain from eyelash growth products containing prostaglandins for the duration of the trial.
• \. 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.

Sponsors & Collaborators

• Toyos Clinic: lead

Study Sites (1)

West Tennesse Eye Care dba Toyos Clinic

Nashville, Tennessee, 37215, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

lifitegrast

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Melissa Toyos, MD

  West Tennessee Eyecare dba Toyos Clinic

  PRINCIPAL INVESTIGATOR

• Rolando Toyos, MD

  West Tennessee Eyecare dca Toyos Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Toyos, MD

CONTACT

615-327-4015; mtoyos@toyosclinic.com

Rolando Toyos, MD

CONTACT

615-327-4015; rostar80@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: May 1, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (1)