Dry Eye, Dry Eyes Chronic, Dry Eye Syndromes
Conditions
Keywords
Dry Eye, Lifitegrast, Xiidra
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.
Interventions
Participants will received lifitegrast 5% ophthalmic solution twice a day in each eye for approximately 4 weeks.
Sponsors
Novartis
Weill Medical College of Cornell University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in proportion of subjects demonstrating improved tear film osmolarity | Baseline, Weeks 1, 2, 3 and 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of subjects demonstrating normal Matrix Metallopeptidase 9 (MMP9). | Week 4 | Normal MMP9 is determined by 2 blinded investigators who each independently read the test result as negative and who are in agreement. |
| The proportion of subjects demonstrating normal Tear Break-Up Time (TBUT). | Week 4 | Greater than 10 seconds is normal, 5 to 10 seconds is marginal, and less than 5 seconds is low. |
| The proportion of subjects demonstrating normal corneal fluorescein staining. | Week 4 | Corneal staining will be assessed using the National Eye Institute Scale for corneal staining. |
| The proportion of subjects demonstrating improvement in their symptoms as measured by the modified SANDE Questionnaire. | Week 4 | 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. |
Countries
United States
Outcome results
None listed