Back to resultsEffects of Xiidra on Closed Eye Tear Film Leukocytes in Dry Eye Disease
Primary Purpose
Ocular Discomfort, Ocular Inflammation, Dry Eye
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Lifitegrast
Sponsored by
About this trial
This is an interventional basic science trial for Ocular Discomfort focused on measuring dry eye disease, neutrophil, T cell, lifitegrast, contact lens discomfort, ocular surface homeostasis
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Normal, asymptomatic non-lens wearers
Dry eye subjects, non-lens wearers
Contact lens wearers with discomfort
Arm Description
Lifitegrast ophthalmic solution, 5.0%. Dosage: 1 drop in each eye, twice daily: once in the morning and once before bed.
Lifitegrast ophthalmic solution, 5.0%. Dosage: 1 drop in each eye, twice daily: once in the morning and once before bed.
Lifitegrast ophthalmic solution, 5.0%. Dosage: 1 drop in each eye, twice daily: once in the morning and once before bed.
Outcomes
Primary Outcome Measures
Change from baseline in the total number of T cells recovered from the closed eye 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
Change from baseline in the total number of neutrophils recovered from the closed eye 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.
Full Information
NCT ID
NCT03408015
First Posted
January 17, 2018
Last Updated
May 15, 2019
Sponsor
University of Alabama at Birmingham
Collaborators
Shire
1. Study Identification
Unique Protocol Identification Number
NCT03408015
Brief Title
Effects of Xiidra on Closed Eye Tear Film Leukocytes in Dry Eye Disease
Official Title
Effects of Xiidra on Closed Eye Tear Film Leukocytes in Dry Eye Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Study timing was poor.
Study Start Date
January 2019 (Anticipated)
Primary Completion Date
January 30, 2019 (Actual)
Study Completion Date
January 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Shire
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Discomfort, Ocular Inflammation, Dry Eye, Contact Lens Complication, Keratoconjunctivitis Sicca
Keywords
dry eye disease, neutrophil, T cell, lifitegrast, contact lens discomfort, ocular surface homeostasis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
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)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normal, asymptomatic non-lens wearers
Arm Type
Experimental
Arm Description
Lifitegrast ophthalmic solution, 5.0%. Dosage: 1 drop in each eye, twice daily: once in the morning and once before bed.
Arm Title
Dry eye subjects, non-lens wearers
Arm Type
Experimental
Arm Description
Lifitegrast ophthalmic solution, 5.0%. Dosage: 1 drop in each eye, twice daily: once in the morning and once before bed.
Arm Title
Contact lens wearers with discomfort
Arm Type
Experimental
Arm Description
Lifitegrast ophthalmic solution, 5.0%. Dosage: 1 drop in each eye, twice daily: once in the morning and once before bed.
Intervention Type
Drug
Intervention Name(s)
Lifitegrast
Other Intervention Name(s)
Xiidra
Intervention Description
Lifitegrast ophthalmic solution, 5.0%. 1 drop instilled into each eye once in the morning and once before bed.
Primary Outcome Measure Information:
Title
Change from baseline in the total number of T cells recovered from the closed eye to day 84
Description
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.
Time Frame
Baseline to day 84
Secondary Outcome Measure Information:
Title
Change from baseline in the total number of neutrophils recovered from the closed eye to day 84.
Description
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.
Time Frame
Baseline to day 84.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly K Nichols, OD MPH PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Xiidra on Closed Eye Tear Film Leukocytes in Dry Eye Disease
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