Effect of Lifitegrast on Dry Eye Disease Signs and Symptoms (Lifitegrast)

March 16, 2018 updated by: Lifelong Vision Foundation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Lifelong Vision Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Lifitegrast
All subjects meet dry eye inclusion and will be treated with Lifitegrast gtts BID
Active Comparator: 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.
Drug: Lifitegrast
All subjects meet dry eye inclusion and will be treated with Lifitegrast gtts BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to the study completion, up to 3 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS
Time Frame: 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.
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
Time Frame: 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.
Baseline to the study completion, up to 3 months.
TBUT
Time Frame: 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.
Baseline to the study completion, up to 3 months.
MGD grade
Time Frame: Baseline to the study completion, up to 3 months.
Visual grading of Meibomian gland clogging.
Baseline to the study completion, up to 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lifelong Vision Foundation

Investigators

  • Principal Investigator: Jay S Pepose, MD, PhD, Pepose Vision Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2016

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

March 15, 2018

Study Registration Dates

First Submitted

December 1, 2016

First Submitted That Met QC Criteria

February 23, 2018

First Posted (Actual)

March 1, 2018

Study Record Updates

Last Update Posted (Actual)

March 19, 2018

Last Update Submitted That Met QC Criteria

March 16, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5720

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dry Eye

Clinical Trials on Lifitegrast

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe