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

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.

Study Overview

• Status: Recruiting
• Conditions: Dry Eye
• Intervention / Treatment: Drug: Xiidra

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jill Woods, McOptom; Phone Number: 36743 519-888-4567; Email: jwoods@uwaterloo.ca

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • Recruiting
      • Centre for Ocular Research & Education
      • Contact: Jill Woods, McOptom; Phone Number: 36743 519-888-4567; Email: jwoods@uwaterloo.ca
      • Principal Investigator: Lyndon Jones, PhD, FCOptom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in contact lens-related discomfort at 12 weeks compared to baseline	Participants rate their contact lens-related discomfort on a scale from 0 (no discomfort) to 100 (maximal discomfort).	Baseline and 12 weeks
Difference in contact lens-related dryness at 12 weeks compared to baseline	Participants rate their contact lens-related dryness on a scale from 0 (no discomfort) to 100 (maximal discomfort).	Baseline and 12 weeks

Collaborators and Investigators

• Sponsor: University of Waterloo
• Collaborators: Novartis
• Investigators: Principal Investigator: Lyndon Jones, PhD, FCOptom, Centre for Ocular Research & Education

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2021
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: March 3, 2020
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (Actual): March 5, 2020

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes; Pharmaceutical Solutions; Ophthalmic Solutions; Lifitegrast
• Other Study ID Numbers: 41189

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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