Effects of Xiidra on Closed Eye Tear Film Leukocytes in Dry Eye Disease

Last updated: May 15, 2019
Sponsor: University of Alabama at Birmingham
Overall Status: Trial Not Available

Phase

4

Condition

Dry Eye Disease

Dry Eyes

Uveitis

Treatment

N/A

Clinical Study ID

NCT03408015
300001139
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Every night during sleep, there is an accumulation of white blood cells in the closed eye. The closed eye white blood cells are predominantly neutrophils, but there is a small population (3%) of T cells. The effects of these closed eye white blood cells on dry eye disease pathogenesis have yet to be fully elucidated, but preliminary evidence suggests that closed eye neutrophils may have an associated hyperactivity and increased degranulation in dry eye disease that could contribute to epithelial instability. As an anti-T cell therapy, Xiidra offers an opportunity to better understand how the closed eye white blood cells are recruited and activated. This study also seeks to verify the proposed mechanism of action.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Able to understand and sign an informed consent and HIPAA privacy document

  • Greater than 18 years of age at time of informed consent

  • Able and willing to follow protocol instructions

  • Capable of performing at-home eye wash

  • Must be willing to drop off samples and comply with study visit procedures

  • For contact lens wearers, must wear lenses at least four hours per day, four days perweek

Exclusion

Exclusion Criteria:

  • Current cigarette smokers

  • Current participation in any investigational drug or device study. If subjects chooseto participate in another investigational drug or device study, they will bediscontinued from this study protocol.

  • Current pregnancy or nursing as indicated by self-report. While not a safety issue,pregnancy or nursing influences the biochemical composition of the tear film.

  • Any systemic health conditions that alter tear film physiology

  • A history of ocular surgery within the past 12 months

  • Any active ocular infection or inflammation

  • Any present use of Accutane or ocular medications

  • Any history of significant adverse reaction to lifitegrast or other components of thedrug product, or contraindication to the use of lifitegrast or other components of thedrug product

  • Any prior exposure to lifitegrast.

  • For normal and dry eye subjects, any history of contact lens wear within the pastthree months.

  • For contact lens wearers, any change of soft contact lens brand or care solutionswithin 30 days prior to screening or any anticipation of changing current type/brandof contact lenses or care solutions throughout the 84 day study

  • Any condition, which in the examiner's opinion, may put the subject at significantrisk, confound study results, or interfere with their participation in the study.

Study Design

Study Start date:
January 01, 2019
Estimated Completion Date:
January 30, 2019

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

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