Dry EyeNCT07705893
Treating Contact Lens Discomfort With Varenicline Solution Nasal Spray 0.03mg
A study testing Tyrvaya in people with Dry Eye, run by Ocular Aesthetics, LLC dba Ocular Clinical Trials at 1 site in United States.
Trial summary
The objective of this study is to evaluate whether twice-daily use of Tyrvaya improves contact lens comfort in contact lens wearers. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Tyrvaya
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ocular Clinical Trials
Houston, Texas, 77027
Vanesa Flores, OD, (713) 838-2020, drflores@ocularclinicaltrials.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Dry Eye
- Being tested
- Tyrvaya
- Keywords
- Tyrvaya, Dry Eye, Contact Lens, Symptoms
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TyrvayaDrug
Also called Varenicline Solution Nasal Spray 0.03mg
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tyrvaya |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline as compared to 12 weeks
Secondary outcomes (3)
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
The contact lens dry eye questionnaire will be utilized to determine contact lens comfort
Measured: 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
Measured: 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
Measured: 4 weeks and 12 weeks compared to baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start28 Jul 2026
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ocular Aesthetics, LLC dba Ocular Clinical Trials
- Sponsor type
- University, hospital or other
- Collaborators
- Viatris Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07705893
- Sponsor's protocol ID
- IRB ID 16875
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32612404
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of Treating Contact Lens Discomfort With Varenicline Solution Nasal Spray 0.03mg
- ClinicalTrials.gov ID
- NCT07705893
- Acronym / sponsor ID
- IRB ID 16875
- Conditions
- Dry Eye
- Keywords
- Tyrvaya, Dry Eye, Contact Lens, Symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ocular Aesthetics, LLC dba Ocular Clinical TrialsUniversity, hospital or other
- Collaborators
- Viatris Inc.
- Study start
- 28 Jul 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate whether twice-daily use of Tyrvaya improves contact lens comfort in contact lens wearers.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tyrvaya | Experimental | Drug: TyrvayaParticipants 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TyrvayaAlso: Varenicline Solution Nasal Spray 0.03mgTyrvaya (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. | Drug | Tyrvaya |
Primary outcome
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.
3 secondary outcomes
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
Time frame: 2 and 4 weeks as compared to baseline
Visual Analog Scale Scores
Time frame: 2 weeks, 4 weeks, and 12 weeks compared to baseline
Corneal Fluorescein Staining
Time frame: 4 weeks and 12 weeks compared to baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Background: PubMed 32612404Pucker 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tyrvaya in people with Dry Eye, run by Ocular Aesthetics, LLC dba Ocular Clinical Trials at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bridgitte Shen Lee, OD (713-838-2020, drshenlee@ocularclinicaltrials.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) (time frame: Baseline as compared to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07705893, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.