Effect of Lifitegrast on Dry Eye Disease Signs and Symptoms

Phase 4

Completed

• Conditions: Dry Eye
• Interventions: Drug: Lifitegrast

• Registration Number: NCT03451396
• Lead Sponsor: Lifelong Vision Foundation

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.

Study Timeline

• Study First Submitted: 2016-12-01
• Study Start: 2016-12-12
• Primary Completion: 2018-02-01
• Study First Submitted QC: 2018-02-23
• Status Verified: 2018-03
• Study First Posted: 2018-03-01
• Study Completion: 2018-03-15
• Last Update Submitted: 2018-03-16
• Last Update Posted: 2018-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mild Dry Eye Cohort	Lifitegrast	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	Lifitegrast	Prospective 3 month study of subjects with Tear Osmolarity \>320 and VAS eye dryness ≥ 40 using 5% Lifitegrast ophthalmic solution BID.

Primary Outcome Measures

Name	Time	Method
Primary: Tear osmolarity	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 Outcome Measures

Name	Time	Method
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	Participants self scored mean average on a scale of 0: none to 10: severe of Eye Dryness, Burning/Stinging, Foreign Body Sensation, Pain, Photophobia, Itching, and Blurred Vision.
Corneal Staining Grade	Baseline to the study completion, up to 3 months.	Percentage of cornea with cell loss/fluorescein dye uptake. The higher the percentage the higher the grade.
TBUT	Baseline to the study completion, up to 3 months.	Tear Film Break-Up Time; measurement of seconds it take for the tear film to start evaporating from the cornea.
MGD grade	Baseline to the study completion, up to 3 months.	Visual grading of Meibomian gland clogging.

Trial Locations

Locations (1)

Lifelong Vision Foundation; 🇺🇸 Chesterfield, Missouri, United States