Recruiting

Tyrvaya

Sponsor:

Ocular Aesthetics, LLC dba Ocular Clinical Trials

Code:

NCT07705893

Conditions

Dry Eye

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Tyrvaya

Study Details

Brief summary:

The objective of this study is to evaluate whether twice-daily use of Tyrvaya improves contact lens comfort in contact lens wearers.

Conditions

Dry Eye

Study ID

NCT07705893

Start date

Jul 28, 2026

Status verified date

Jul, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tyrvaya

Participants will be given Tryvaya (Varenicline Solution Nasal Spray 0.03 mg) and instructed to use it twice daily while wearing their contact lenses to determine if the spray relieves symptoms associated with dry eye disease, and thus increases contact lens comfort.

Interventions

Tyrvaya

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.

Primary outcome measure

  • Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) [ Time Frame: Baseline as compared to 12 weeks ]

Central Contacts and Locations

Central contacts

Bridgitte Shen Lee, OD

713-838-2020drshenlee@ocularclinicaltrials.com

Locations

Ocular Clinical Trials

Recruiting

Houston, Texas, United States, 77027

Contacts

Vanesa Flores, OD

(713) 838-2020drflores@ocularclinicaltrials.com

More Information

Sponsor

Ocular Aesthetics, LLC dba Ocular Clinical Trials

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Keywords

  • Tyrvaya
  • Dry Eye
  • Contact Lens
  • Symptoms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ocular Aesthetics, LLC dba Ocular Clinical Trials on 2026-07-30.