Effect of Lifitegrast on Dry Eye Disease Signs and Symptoms

Study Overview
=================
Brief Summary
-----------------
To determine whether a fall in tear osmolarity precedes improvement in symptoms and signs of dry eye in dry eye patients treated topically with 5% lifitegrast drops for 3 months.

Detailed Description
-----------------
A longitudinal, single-arm, prospective study will recruit up to 30 subjects with moderate to severe dry eye disease. Subjects will be >18 years of age, diagnosed with moderate to severe dry eye (tear osmolarity > 320 mOsm/L and Visual Analog Scale (VAS) score > 40), willing to adhere to twice daily dosing (BID) and follow up visit schedule, have no history of ocular pathology / degeneration / allergy, not on any T-cell modulatory therapy, not have instilled any artificial tears within 2 hours of study visit, and not participating in any concurrent clinical trials. All subjects will complete an informed consent form indicating their voluntary participation in the study. Study measurements will be made at baseline (first clinic visit), 2-, 6-, and 12-weeks following Lifitegrast therapy and include tear osmolarity (TearLab osmolarity system), VAS questionnaire, slit lamp examination for fluorescein corneal staining, tear break up time (TBUT), and Meibomian gland dysfunction (MGD) grading . At the end of the 3-mo study visit, the subjects will be informed of study completion and exited from the study.

Official Title
-----------------
Effect of Lifitegrast on Dry Eye Disease Signs and Symptoms

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Drug: Lifitegrast


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tear Osmolarity > 320 mOsm/L VAS eye dryness > 40 No other ocular pathology No contact lens wear Not currently on T cell modulator No change in therapy in last 2 months Willingness to adhere to therapy and study visits Patients qualified for prescription of lifitegrast drops Exclusion Criteria: Contact lens use Eye surgery in Past 6 months Use of tear supplements in past 2 hours

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mild Dry Eye Cohort<br>Prospective 3 month study of subjects with Tear Osmolarity >308 and VAS eye dryness ≥ 40 using 5% Lifitegrast ophthalmic solution BID. | Drug: Lifitegrast<br>* All subjects meet dry eye inclusion and will be treated with Lifitegrast gtts BID<br>|
| Active Comparator: Moderate to Severe Dry Eye Cohort<br>Prospective 3 month study of subjects with Tear Osmolarity >320 and VAS eye dryness ≥ 40 using 5% Lifitegrast ophthalmic solution BID. | Drug: Lifitegrast<br>* All subjects meet dry eye inclusion and will be treated with Lifitegrast gtts BID<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary: Tear osmolarity | Number of participants with an improvement in Tear Osmolarity measured using the Tear Osmolarity score treated with Lifitegrast. | Baseline to the study completion, up to 3 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS | Participants self scored mean average on a scale of 0: none to 10: severe of Eye Dryness, Burning/Stinging, Foreign Body Sensation, Pain, Photophobia, Itching, and Blurred Vision. | VAS dry eye questionnaire, tear break up time and meibomian gland grading will be serially measured over 3 months during treatment with Lifitegrast gtts | 
| Corneal Staining Grade | Percentage of cornea with cell loss/fluorescein dye uptake. The higher the percentage the higher the grade. | Baseline to the study completion, up to 3 months. | 
| TBUT | Tear Film Break-Up Time; measurement of seconds it take for the tear film to start evaporating from the cornea. | Baseline to the study completion, up to 3 months. | 
| MGD grade | Visual grading of Meibomian gland clogging. | Baseline to the study completion, up to 3 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry eye, Tear osmolarity, Lifitegrast