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

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 ormonthly disposable lenses) in both eyes, that are available in Canada, for a minimumof 5 days/week for 6 hours/day over the last month, and is willing to continue to doso during the study;

5. Is a symptomatic CL wearer as determined by Eye Dryness Score4,5 (EDS) ≥40 at theend 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 30days;

8. Is willing to use the Xiidra study drops twice a day on a daily basis (irrespectiveof CL wear) and to stop use of any habitual rewetting drops and/or artificial tearsover 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 gaspermeable 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* orhas occurred within the previous 30 days;

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

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

7. Is pregnant, lactating or planning a pregnancy at the time of enrolment (byself-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 theprevious 6 months,

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