A Clinical Evaluation of Treating Contact Lens Discomfort With Varenicline Solution Nasal Spray 0.03mg
Ocular Aesthetics, LLC dba Ocular Clinical Trials
Summary
The objective of this study is to evaluate whether twice-daily use of Tyrvaya improves contact lens comfort in contact lens wearers.
Description
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…
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * 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 * A VAS score of ≥40 for Eye Dryness and End of Day Contact Lens Discomfort;18, 19 * A corneal fluorescein staining on the original NEI scale of ≥3. * Habitually wears soft CLs for a minimum of 5 days per…
Interventions
- DrugTyrvaya
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.
Location
- Ocular Clinical TrialsHouston, Texas