Clinical trial NCT04297618: The Effect of Xiidra on Comfort and Dryness in Symptomatic Contact Lens Wearers
Official title: The Effect of Xiidra on Comfort and Dryness in Symptomatic Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye
Lead sponsor: University of Waterloo
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2020-03-05
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Difference in Contact Lens-related Discomfort at 12 Weeks Compared to Baseline
timeFrame: Baseline and 12 weeks
measure: Difference in Contact Lens-related Dryness at 12 Weeks Compared to Baseline
timeFrame: Baseline and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Centre for Ocular Research & Education
state: Ontario
Study officials:
affiliation: Centre for Ocular Research & Education
name: Lyndon Jones, PhD, FCOptom
role: PRINCIPAL_INVESTIGATOR
References: