Treating Contact Lens Discomfort With Varenicline Solution Nasal Spray 0.03mg

NCT07705893 | Recruiting

• 1 other identifier: IRB ID 16875
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Tyrvaya; Dry Eye; Contact Lens; Symptoms

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline as compared to 12 weeks

Secondary Outcomes (3)

• Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)

  2 and 4 weeks as compared to baseline

• Visual Analog Scale Scores

  2 weeks, 4 weeks, and 12 weeks compared to baseline

• Corneal Fluorescein Staining

  4 weeks and 12 weeks compared to baseline.

Study Arms (1)

Tyrvaya

EXPERIMENTAL

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.

Drug: Tyrvaya

Interventions

Tyrvaya DRUG

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.

Also known as: Varenicline Solution Nasal Spray 0.03mg

Tyrvaya

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ocular Aesthetics, LLC dba Ocular Clinical Trials: lead
• Viatris Inc.: collaborator

Study Sites (1)

Ocular Clinical Trials

Houston, Texas, 77027, United States

RECRUITING

Related Publications (1)

• Pucker AD, Tichenor AA. A Review of Contact Lens Dropout. Clin Optom (Auckl). 2020 Jun 25;12:85-94. doi: 10.2147/OPTO.S198637. eCollection 2020.

  PMID: 32612404 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Central Study Contacts

Bridgitte Shen Lee, OD

CONTACT

713-838-2020; drshenlee@ocularclinicaltrials.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 15, 2026
• Study Start: July 28, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)