Clinical trial for Dry Eye
Official title Treating Contact Lens Discomfort With Varenicline Solution Nasal Spray 0.03mg
ClinicalTrials.gov ID: NCT07705893
What this study is testing
What is Tyrvaya?
Tyrvaya is an investigational medicine, given as an once-daily, being studied as a potential treatment for dry eye.
Also referred to as Varenicline Solution Nasal Spray 0.03mg.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The objective of this study is to evaluate whether twice-daily use of Tyrvaya improves contact lens comfort in contact lens wearers.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99. Healthy volunteers may be eligible.
You may be able to join if
- Adult male and female people 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
You likely can't join 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.
See the full eligibility criteria
- Adult male and female people 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...
- Willing to record daily time for CL application, removal, and Tyrvaya applications.
- Habitual CLs have an acceptable fit (good centration, movement, and coverage
- 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).
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here - ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.