Lifitegrast for Dry Eye Syndrome

((IVCM) Trial)

Overseen By Rolando Toyos, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Toyos Clinic

Must not be taking: Topical steroids, Oral corticosteroids

Disqualifiers: Contact lens use, Pregnancy, Ocular surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

Melissa Toyos, MD

Principal Investigator

West Tennessee Eyecare dba Toyos Clinic

Rolando Toyos, MD

Principal Investigator

West Tennessee Eyecare dca Toyos Clinic

Are You a Good Fit for This Trial?

Inclusion Criteria

I am postmenopausal or have had surgery to remove my uterus or both ovaries.

* 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Lifitegrast Ophthalmic Solution 5.0% (Xiidra) for dry eye disease

12 weeks

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lifitegrast Ophthalmic Solution 5.0%

How Is the Trial Designed?

Group I: DED subjects treated with lifitegrast ophthalmic solution 5.0% (Xiidra) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Toyos Clinic

Lead Sponsor

Trials

9

Recruited

260+