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

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ClinicalTrials.gov Identifier: NCT03408015
Recruitment Status : Withdrawn (Study timing was poor.)
First Posted : January 23, 2018
Last Update Posted : January 21, 2019
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Kelly Nichols, University of Alabama at Birmingham

Brief 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.

Condition or disease Intervention/treatment Phase
Ocular Discomfort Ocular Inflammation Dry Eye Contact Lens Complication Keratoconjunctivitis Sicca Drug: Lifitegrast Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Three groups of individuals will be recruited: asymptomatic non-contact lens wearers; symptomatic non-contact lens wearers, with dry eye disease; symptomatic contact lens wearers, with contact lens discomfort. All three groups will receive the same Xiidra treatment for the complete study duration.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Xiidra on Closed Eye Tear Film Leukocytes in Dry Eye Disease
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases Tears
Drug Information available for: Lifitegrast

Arm Intervention/treatment
Experimental: Normal, asymptomatic non-lens wearers
Lifitegrast ophthalmic solution, 5.0%. Dosage: 1 drop in each eye, twice daily: once in the morning and once before bed.
Drug: Lifitegrast
Lifitegrast ophthalmic solution, 5.0%. 1 drop instilled into each eye once in the morning and once before bed.
Other Name: Xiidra

Experimental: Dry eye subjects, non-lens wearers
Lifitegrast ophthalmic solution, 5.0%. Dosage: 1 drop in each eye, twice daily: once in the morning and once before bed.
Drug: Lifitegrast
Lifitegrast ophthalmic solution, 5.0%. 1 drop instilled into each eye once in the morning and once before bed.
Other Name: Xiidra

Experimental: Contact lens wearers with discomfort
Lifitegrast ophthalmic solution, 5.0%. Dosage: 1 drop in each eye, twice daily: once in the morning and once before bed.
Drug: Lifitegrast
Lifitegrast ophthalmic solution, 5.0%. 1 drop instilled into each eye once in the morning and once before bed.
Other Name: Xiidra




Primary Outcome Measures :
  1. Change from baseline in the total number of T cells recovered from the closed eye to day 84 [ Time Frame: Baseline to day 84 ]
    Subjects will be trained and required to collect their closed eye tears at home, using a gentle saline rinse of the ocular surface. Enumeration of recovered T cells will be performed by flow cytometry.


Secondary Outcome Measures :
  1. Change from baseline in the total number of neutrophils recovered from the closed eye to day 84. [ Time Frame: Baseline to day 84. ]
    Subjects will be trained and required to collect their closed eye tears at home, using a gentle saline rinse of the ocular surface. Enumeration of recovered neutrophils will be performed by flow cytometry.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 per week

Exclusion Criteria:

  • Current cigarette smokers
  • Current participation in any investigational drug or device study. If subjects choose to participate in another investigational drug or device study, they will be discontinued 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 the drug product, or contraindication to the use of lifitegrast or other components of the drug product
  • Any prior exposure to lifitegrast.
  • For normal and dry eye subjects, any history of contact lens wear within the past three months.
  • For contact lens wearers, any change of soft contact lens brand or care solutions within 30 days prior to screening or any anticipation of changing current type/brand of contact lenses or care solutions throughout the 84 day study
  • Any condition, which in the examiner's opinion, may put the subject at significant risk, confound study results, or interfere with their participation in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03408015


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Shire
Investigators
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Principal Investigator: Kelly K Nichols, OD MPH PhD University of Alabama at Birmingham

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Responsible Party: Kelly Nichols, Dean, Principal Investigator, UAB School of Optometry, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03408015     History of Changes
Other Study ID Numbers: 300001139
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Kelly Nichols, University of Alabama at Birmingham:
dry eye disease
neutrophil
T cell
lifitegrast
contact lens discomfort
ocular surface homeostasis

Additional relevant MeSH terms:
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Inflammation
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Pathologic Processes
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Lifitegrast
Pharmaceutical Solutions