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

NCT03408015 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 300001139
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to day 84

Secondary Outcomes (1)

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

  Baseline to day 84.

Study Arms (3)

Normal, asymptomatic non-lens wearers

EXPERIMENTAL

Lifitegrast ophthalmic solution, 5.0%. Dosage: 1 drop in each eye, twice daily: once in the morning and once before bed.

Drug: Lifitegrast

Dry eye subjects, non-lens wearers

EXPERIMENTAL

Lifitegrast ophthalmic solution, 5.0%. Dosage: 1 drop in each eye, twice daily: once in the morning and once before bed.

Drug: Lifitegrast

Contact lens wearers with discomfort

EXPERIMENTAL

Lifitegrast ophthalmic solution, 5.0%. Dosage: 1 drop in each eye, twice daily: once in the morning and once before bed.

Drug: Lifitegrast

Interventions

Lifitegrast DRUG

Lifitegrast ophthalmic solution, 5.0%. 1 drop instilled into each eye once in the morning and once before bed.

Also known as: Xiidra

Contact lens wearers with discomfort; Dry eye subjects, non-lens wearers; Normal, asymptomatic non-lens wearers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Shire: collaborator

MeSH Terms

Conditions

Dry Eye Syndromes; Keratoconjunctivitis Sicca

Interventions

lifitegrast

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases

Study Officials

• Kelly K Nichols, OD MPH PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean, Principal Investigator, UAB School of Optometry

Model Details: 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.

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: January 23, 2018
• Study Start: January 1, 2019
• Primary Completion: January 30, 2019
• Study Completion: January 30, 2019
• Last Updated: May 17, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share