Treating Contact Lens Discomfort With Varenicline Solution Nasal Spray 0.03mg

A Clinical Evaluation of Treating Contact Lens Discomfort With Varenicline Solution Nasal Spray 0.03mg

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

Study Overview

• Status: Not yet recruiting
• Conditions: Dry Eye
• Intervention / Treatment: Drug: Tyrvaya

Detailed 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 twice-daily use of Tyrvaya improves contact lens comfort in contact lens wearers.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bridgitte Shen Lee, OD; Phone Number: 713-838-2020; Email: drshenlee@ocularclinicaltrials.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Drug: 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.; Other Names: Varenicline Solution Nasal Spray 0.03mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)	The contact lens dry eye questionnaire will be utilized to determine contact lens comfort	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	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	4 weeks and 12 weeks compared to baseline.

Collaborators and Investigators

• Sponsor: Ocular Aesthetics, LLC dba Ocular Clinical Trials
• Collaborators: Viatris Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: July 10, 2026
• First Submitted That Met QC Criteria: July 10, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 10, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Dry Eye; Symptoms; Contact Lens; Tyrvaya
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: irb_placeholder

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes