NCT07705893 · Ocular Aesthetics, LLC dba Ocular Clinical Trials
Treating Contact Lens Discomfort With Varenicline Solution Nasal Spray 0.03mg
What this study is about
The objective of this study is to evaluate whether twice-daily use of Tyrvaya improves contact lens comfort in contact lens wearers.
View original scientific description
The objective of this study is to evaluate whether twice-daily use of Tyrvaya improves contact lens comfort in contact lens wearers.
Interventions
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.
Primary outcome measures
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
Time frame: Baseline as compared to 12 weeks
The contact lens dry eye questionnaire will be utilized to determine contact lens comfort with lower scores indicating more comfort.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Houston, Texas
Collaborators
Viatris Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 30, 2026 · Source of record for eligibility and locations