Effect of Lifitegrast on Dry Eye Disease Signs and Symptoms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-12

Study Completion Date

2018-03-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dry Eye

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Lifitegrast

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Lifitegrast

Intervention Type DRUG

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

Interventions

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Lifitegrast

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

Intervention Type DRUG

Eligibility Criteria

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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