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

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03408015

Collaborator

Shire (Industry)

Enrollment

Arms

Anticipated Duration (Days)

Study Details

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.

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

Study Design

Study Type:

Interventional

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.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

Anticipated Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Jan 30, 2019

Actual Study Completion Date :

Jan 30, 2019

Arms and Interventions

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 Names: 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 Names: 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 Names: Xiidra

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 Names:

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 Names:

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 Names:

Xiidra

Outcome Measures

Primary Outcome Measures

Change from baseline in the total number of T cells recovered from the closed eye to day 84 [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

Change from baseline in the total number of neutrophils recovered from the closed eye to day 84. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.