The objective of this study is to evaluate whether twice-daily use of Tyrvaya improves contact lens comfort in contact lens wearers.
Adult male and female subjects of any race or ethnicity who are ≥18 years of age.
Best corrected CL visual acuity of 0.3 Logarithm of the Minimum Angle of Resolution (logMAR) or better in both eyes (Snellen equivalent 20/40).
Soft 1-day silicone hydrogel CL wearer (daily disposable only)
Contact Lens Dry Eye Questionnaire (CLDEQ)-8 scores (CLDEQ-8 scores ≥ 12).16
Any history of Tyrvaya use within six months of enrollment
Are currently an overnight CL wearer.
Are currently wearing rigid gas permeable CLs, scleral CL, hybrid CLs, or reusable soft CLs.
Have known systemic health conditions that are known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome).
Single group
Tyrvaya
DrugTyrvaya (varenicline solution 0.03 mg) is a nasal spray, which is dosed twice daily, that is indicated for treating signs and symptoms of dry eye disease (DED )This dropless ocular surface sparing dosing pattern is ideal for the busy CL patient because they can easily administer Tyrvaya twice a day while keeping their contact lens on.
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
The contact lens dry eye questionnaire will be utilized to determine contact lens comfort with lower scores indicating more comfort.
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
The contact lens dry eye questionnaire will be utilized to determine contact lens comfort
Visual Analog Scale Scores
Eye Dryness, Fluctuating Vision, OVERALL Contact Lens Discomfort, and END of DAY Contact Lens Discomfort will be evaluated with a -50 to +50 visual analog scale with higher scored indicating more comfort
Corneal Fluorescein Staining
Corneal staining will be ascertained using the original NEI scale (0-15 scale) with higher numbers indicating worse scores
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Ocular Aesthetics, LLC dba Ocular Clinical Trials
Lead sponsor
Viatris Inc.
Collaborator
