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COLLIE: The Effect of Xiidra on Comfort and Dryness in Symptomatic Contact Lens Wearers

Sponsor
University of Waterloo (Other)
Overall Status
Recruiting
CT.gov ID
NCT04297618
Collaborator
Novartis (Industry)
40
Enrollment
1
Location
1
Arm
15.8
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study to evaluate changes in comfort and dryness in symptomatic contact lens (CL) wearers after using Xiidra (lifitegrast 5.0% ophthalmic solution) for 12 weeks.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Xiidra on Comfort and Dryness in Symptomatic Contact Lens Wearers
Actual Study Start Date :
Jul 7, 2021
Anticipated Primary Completion Date :
Oct 30, 2022
Anticipated Study Completion Date :
Oct 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Xiidra treatment

Each participant will use the same study drops, Xiidra, over the course of the 12-week study.

Drug: Xiidra
Xiidra (lifitegrast 5% ophthalmic solution)
Other Names:
  • Lifitegrast

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Difference in contact lens-related discomfort at 12 weeks compared to baseline [Baseline and 12 weeks]

      Participants rate their contact lens-related discomfort on a scale from 0 (no discomfort) to 100 (maximal discomfort).

    2. Difference in contact lens-related dryness at 12 weeks compared to baseline [Baseline and 12 weeks]

      Participants rate their contact lens-related dryness on a scale from 0 (no discomfort) to 100 (maximal discomfort).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Is at least 18 years of age and has full legal capacity to volunteer;

    2. Has read and signed an information consent letter;

    3. Is willing and able to follow instructions and maintain the appointment schedule;

    4. Currently wears daily, soft, frequent replacement lenses (daily, bi-weekly or monthly disposable lenses) in both eyes, that are available in Canada, for a minimum of 5 days/week for 6 hours/day over the last month, and is willing to continue to do so during the study;

    5. Is a symptomatic CL wearer as determined by Eye Dryness Score4,5 (EDS) ≥40 at the end of the wear day AND according to the classification by Young et al7;

    6. Can achieve acceptable lens fit as well as visual acuity (VA) correctable to logMAR +0.20 or better in each eye with their habitual contact lens type;

    7. Has a history of artificial tear or rewetting drop use at least once in the last 30 days;

    8. Is willing to use the Xiidra study drops twice a day on a daily basis (irrespective of CL wear) and to stop use of any habitual rewetting drops and/or artificial tears over the course of the 12-week treatment phase;

    Exclusion Criteria:

    1. Is participating in any concurrent clinical or research study;

    2. Is wearing soft CLs on an extended wear basis (i.e. overnight) or is a rigid gas permeable lens or hybrid lens wearer;

    3. Has a known sensitivity to the investigational product or diagnostic substances (e.g. fluorescein) to be used in the study;

    4. Has any known ocular disease and/or infection, that's either currently active* or has occurred within the previous 30 days;

    5. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable (examples may include active or uncontrolled systemic conditions such as allergies, autoimmune disease or immunodeficiency disease);

    6. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable, including but not limited to topical cyclosporine, any other topical ophthalmic medication, antihistamines, and aspirin;

    7. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by self-report);**

    8. Has undergone refractive error surgery such as LASIK within the last 12 months;

    9. Has a history of yttrium-aluminium-garnet laser posterior capsulotomy within the previous 6 months,

    10. Is an employee of the Centre for Ocular Research & Education; * For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre for Ocular Research & Education Waterloo Ontario Canada N2L 3G1

    Sponsors and Collaborators

    • University of Waterloo
    • Novartis

    Investigators

    • Principal Investigator: Lyndon Jones, PhD, FCOptom, Centre for Ocular Research & Education

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Waterloo
    ClinicalTrials.gov Identifier:
    NCT04297618
    Other Study ID Numbers:
    • 41189
    First Posted:
    Mar 5, 2020
    Last Update Posted:
    Feb 15, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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.:
    Yes
    Additional relevant MeSH terms:
    Dry Eye Syndromes
    Lifitegrast

    Study Results

    No Results Posted as of Feb 15, 2022