The objective of this study is to evaluate whether twice-daily use of Tyrvaya improves contact lens comfort in contact lens wearers.
Although more than 140 million people worldwide wear contact lenses, approximately 20% discontinue use, with discomfort being the primary reason. Contact lens discomfort is a multifactorial condition influenced by environmental factors, patient compliance, lens design, and fit, and is often associated with underlying dry eye disease. Dry eye can significantly reduce comfort and contribute to contact lens dropout. Tyrvaya® (varenicline solution 0.03 mg) is a twice-daily nasal spray approved to relieve the signs and symptoms of dry eye disease. The objective of this study is to evaluate whether twice-daily use of Tyrvaya improves contact lens comfort in contact lens wearers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Tyrvaya (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.
Ocular Clinical Trials
Houston, Texas, United States
RECRUITINGContact 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.
Time frame: Baseline as compared to 12 weeks
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
The contact lens dry eye questionnaire will be utilized to determine contact lens comfort
Time frame: 2 and 4 weeks as compared to baseline
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
Time frame: 2 weeks, 4 weeks, and 12 weeks compared to baseline
Corneal Fluorescein Staining
Corneal staining will be ascertained using the original NEI scale (0-15 scale) with higher numbers indicating worse scores
Time frame: 4 weeks and 12 weeks compared to baseline.
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