Effect of Lifitegrast 5% on Tear Film Markers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the duration of time (in weeks) for improvement in objective dry eye markers for people who are placed on lifitegrast 0.5% (Xiidra®), an FDA-approved therapy for dry eyes.

Official Title
-----------------
Improvement in Markers of Tear Film Instability After Initiation of Lifitegrast 5% Ophthalmic Solution: A Prospective Interventional Study

Conditions
-----------------
Dry Eye, Dry Eye Syndromes, Dry Eyes Chronic

Intervention / Treatment
-----------------
* Drug: Lifitegrast 5% Ophthalmic Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signs or symptoms of Dry Eye Disease 18 years or older Abnormal MMP9 (positive as read by 2 blinded investigators with both in agreement) and/or Abnormal tear osmolarity (greater than or equal to 308 or an inter-eye difference >=8 mOsm/mL) Exclusion Criteria: Active eye infection. Patients with blepharitis may be enrolled. Any eye drop that was instilled within 2 hours of the Baseline eye exam Current contact lens wearer. Subjects who have not worn contact lenses 30 days prior to baseline and have no intention to wear CLs during the study duration may enroll. History of ocular herpes simplex Active episcleritis, scleritis, iritis or uveitis Active keratitis secondary to any etiology other than dry eyes History of refractive surgery (LASIK or PRK) or penetrating corneal transplant (PK) Uses eye drops (ex. glaucoma or allergy drops) for indications other than dry eyes Active allergic conjunctivitis Current use of punctal plugs or anticipation of use during the study Use of topical ophthalmic steroids within 14 days of the Baseline Visit or anticipated use during the study Use of lifitegrast 5% or Restasis within 30 Days of the Baseline Visit. Allergy to lifitegrast 5%

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifitegrast 5% Ophthalmic Solution<br>Participants will received lifitegrast 5% ophthalmic solution twice a day in each eye for approximately 4 weeks. | Drug: Lifitegrast 5% Ophthalmic Solution<br>* Participants will received lifitegrast 5% ophthalmic solution twice a day in each eye for approximately 4 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in proportion of subjects demonstrating improved tear film osmolarity | Improved tear film osmolarity will be defined as an osmolarity reading of less than or equal to 308 mOsm/L or an inter-eye difference osmolarity reading of less than or equal to 8 mOsm/L. | Baseline, Weeks 1, 2, 3 and 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects demonstrating normal Matrix Metallopeptidase 9 (MMP9). | Normal MMP9 is determined by 2 blinded investigators who each independently read the test result as negative and who are in agreement. | Week 4 | 
| The proportion of subjects demonstrating normal Tear Break-Up Time (TBUT). | Greater than 10 seconds is normal, 5 to 10 seconds is marginal, and less than 5 seconds is low. | Week 4 | 
| The proportion of subjects demonstrating normal corneal fluorescein staining. | Corneal staining will be assessed using the National Eye Institute Scale for corneal staining. | Week 4 | 
| The proportion of subjects demonstrating improvement in their symptoms as measured by the modified SANDE Questionnaire. | A modified SANDE Questionnaire uses a visual analogue scale at the Baseline Visit to measure the frequency and severity of subject's dry eyes symptoms. Subsequent visit Questionnaires will use a visual analogue scale to measure the change in symptoms compare to the results of the prior visit. | Week 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry Eye, Lifitegrast, Xiidra