Tyrvaya Nasal Spray for Comfort in Contact Lens Wearers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial investigates if twice-daily Tyrvaya (varenicline nasal spray 0.03 mg) improves contact lens comfort in wearers with dry eye symptoms. It targets adults 18 and older who wear daily disposable soft contact lenses and meet specific dryness and corneal staining criteria. Participants will continue their habitual contact lens use and abstain from lipid-containing artificial tears during the 3-month study if they are enrolled. The study is sponsored by Ocular Aesthetics, with Viatris as a collaborator, and is conducted at a single site in Houston, TX. Safety and efficacy outcomes center on changes in contact lens comfort and dry eye symptoms.

Why it matters

Who can join: the full rules

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 week for 6 hours per day during the month prior to enrollment.20
* Willing to maintain habitual CL wear routine for the 3 months duration of the study.20
* Willing to only use Tyrvaya nasal spray prescription dry eye treatment for the 3 months duration of the study.
* Willing to not use any lipid containing artificial tear (AT) for the 3 months duration of the study.
* Willing to only use non-lipid containing preservative free artificial tear for the 3 months duration of the study if needed, but no more than 4 times per day; also must agree to record frequency of daily AT use if applicable.
* Willing to record daily time for CL application, removal, and Tyrvaya applications.
* Habitual CLs have an acceptable fit (good centration, movement, and coverage

Exclusion Criteria:

* 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).
* Have a history of ocular surgery within the past 12 months.
* Have a history of viral eye disease.
* Have a history of severe ocular trauma, active ocular infection or inflammation.
* Have ever used using isotretinoin-derivates (e.g., Accutane).
* Are currently taking ocular medications or plan to during the study (e.g., DED, glaucoma, etc).
* Subjects with meibomian gland blockage or significant atrophy (e.g., severe MGD). Currently having \>50% blockage of Meibomian glands in more than two eyelids
* Having blepharitis and/or demodex blepharitis \> grade 1
* Have had a physical meibomian gland dysfunction treatment withing three months of enrollment (iLux, Lipiflow, Radio Frequency and IPL with manual expressions, microblepharoexfoliation etc.).
* Have used a prescription DED or ocular surface disease medication in the last 1 month.
* Have a condition or in a situation, which in the examiner's opinion, may put the subject at significant risk, may confound the study results, or may significantly interfere with their participation.
* Are pregnant or breast feeding or plan to get pregnant.
* Are a student, employee, or relative of the study team.

Where it's running

• Ocular Clinical Trials
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Bridgitte Shen Lee, OD
• Email: drshenlee@ocularclinicaltrials.com
• Phone: 713-838-2020

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.