Effect of Lifitegrast on Dry Eye Disease Signs and Symptoms
Overview
- Phase
- Phase 4
- Intervention
- Lifitegrast
- Conditions
- Dry Eye
- Sponsor
- Lifelong Vision Foundation
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Primary: Tear osmolarity
- Status
- Completed
- Last Updated
- 8 years ago
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.
Investigators
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
Arms & Interventions
Mild Dry Eye Cohort
Prospective 3 month study of subjects with Tear Osmolarity \>308 and VAS eye dryness ≥ 40 using 5% Lifitegrast ophthalmic solution BID.
Intervention: Lifitegrast
Moderate to Severe Dry Eye Cohort
Prospective 3 month study of subjects with Tear Osmolarity \>320 and VAS eye dryness ≥ 40 using 5% Lifitegrast ophthalmic solution BID.
Intervention: Lifitegrast
Outcomes
Primary Outcomes
Primary: Tear osmolarity
Time Frame: Baseline to the study completion, up to 3 months.
Number of participants with an improvement in Tear Osmolarity measured using the Tear Osmolarity score treated with Lifitegrast.
Secondary Outcomes
- VAS(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(Baseline to the study completion, up to 3 months.)
- TBUT(Baseline to the study completion, up to 3 months.)
- MGD grade(Baseline to the study completion, up to 3 months.)