Trial | NCT03451396  Report issue

Official Title

Effect of Lifitegrast on Dry Eye Disease Signs and Symptoms

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    30
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.
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.
Study Started
Dec 12
2016
Primary Completion
Feb 01
2018
Study Completion
Mar 15
2018
Last Update
Mar 19
2018

Drug Lifitegrast

All subjects meet dry eye inclusion and will be treated with Lifitegrast gtts BID

Mild Dry Eye Cohort Active Comparator

Prospective 3 month study of subjects with Tear Osmolarity >308 and VAS eye dryness ≥ 40 using 5% Lifitegrast ophthalmic solution BID.

Moderate to Severe Dry Eye Cohort Active Comparator

Prospective 3 month study of subjects with Tear Osmolarity >320 and VAS eye dryness ≥ 40 using 5% Lifitegrast ophthalmic solution BID.

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
No Results Posted