Effect of Lifitegrast on Dry Eye Disease Signs and Symptoms

Lifelong Vision Foundation

Status and phase: Completed; Phase 4

Conditions: Dry Eye

Treatments: Drug: Lifitegrast

Study type: Interventional

Funder types: Other

Identifiers

NCT03451396

5720

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Mild Dry Eye Cohort

Active Comparator group

Description:

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

Treatment:

Drug: Lifitegrast

Moderate to Severe Dry Eye Cohort

Active Comparator group

Description:

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

Treatment:

Drug: Lifitegrast