65 Participants NeededMy employer runs this trial

Nasal Spray for Dry Eye Syndrome

MC
LL
Overseen ByLaimeng Lee, OD, MS
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of California, Berkeley
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a nasal spray treatment to improve eye health in individuals with dry eye syndrome caused by mild to moderate Meibomian gland dysfunction (MGD), which affects the oil-producing glands in the eyelids. Researchers aim to determine if the varenicline nasal spray can enhance gland function and alleviate symptoms like dryness and discomfort. Individuals with noticeable dry eye symptoms and mild to moderate MGD, but not severe cases, may be suitable for this study. Participants will use the nasal spray twice daily for three months while discontinuing other dry eye medications. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand its benefits for more patients with dry eye syndrome.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescription medications for dry eye disease and any topical eye drops before all planned visits.

What is the safety track record for the nasal spray treatment?

Research has shown that varenicline nasal spray is generally safe for people with dry eye disease. In clinical trials involving 349 participants, most did not encounter major safety issues. Reports indicate that it is very safe, with fewer discontinuations compared to other dry eye treatments. Some studies also found improvements in eye moisture and comfort, suggesting its effectiveness and safety. However, its safety and effectiveness are not fully confirmed, so further research continues. Overall, current evidence suggests that varenicline nasal spray is a safe option for managing dry eye symptoms.12345

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for dry eye syndrome, which often include artificial tears or anti-inflammatory eye drops, this new nasal spray uses varenicline as its active ingredient. Varenicline targets the trigeminal nerve pathway, which is thought to stimulate natural tear production. Researchers are excited about this treatment because it offers a unique delivery method—administered as a nasal spray rather than eye drops—which could provide more consistent relief and improve patient compliance. This innovative approach may offer a more effective and user-friendly solution for those suffering from dry eye syndrome.

What is the effectiveness track record for Varenicline nasal spray in treating dry eye syndrome?

Research has shown that varenicline nasal spray effectively treats dry eye disease. Studies have found that this spray significantly improves tear production. In one study, participants' tear production increased by about 10.4 mm on a tear measurement test after four weeks of treatment. Other studies confirm that varenicline is safe, and most people experience positive results. The FDA approved this nasal spray in 2021 specifically for dry eye disease, highlighting its effectiveness.13456

Are You a Good Fit for This Trial?

This trial is for people with mild to moderate dry eye symptoms caused by Meibomian gland dysfunction. Participants should have noticeable dry eye discomfort but not severe disease.

Inclusion Criteria

Is willing to stop any topical eye drops before all planned visits
Has read, understood, and completed the informed consent letter
Has had an oculo-visual examination in the last two years
See 6 more

Exclusion Criteria

Is participating in any other type of clinical or research study
Is currently pregnant, nursing, lactating, or planning a pregnancy
Has a known allergy to a product used in this study
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants self-administer varenicline nasal spray 0.03mg solution twice daily for 3 months

12 weeks
Visits at baseline, 1 month, and 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Varenicline 0.03Mg/Spray Nasal Soln

Trial Overview

The study is testing a nasal spray containing varenicline (0.03mg per spray) to see if it improves tear film stability and the health of the eye surface in those with dry eyes from Meibomian gland issues.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Nasal Spray Treatment GroupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Berkeley

Lead Sponsor

Trials
193
Recruited
716,000+

Viatris Inc.

Industry Sponsor

Trials
11
Recruited
5,600+

Citations

Varenicline Solution Nasal Spray: A Review in Dry Eye Disease

Four weeks of treatment with varenicline solution 0.03 mg resulted in statistically significant and clinically meaningful improvements in signs ...

Bilateral Effect of OC-01 (Varenicline Solution) Nasal Spray ...

In the study eyes, the mean STS improvement from baseline to day 28 was 10.4 mm, 10.5 mm, and 4.9 mm in the 0.03 mg, 0.06 mg, and VC groups, respectively; ...

Safety, adherence and discontinuation in varenicline ...

Varenicline solution nasal spray displayed excellent safety in clinical trials as well as greater tolerability and lower discontinuation rates than dry eye ...

Varenicline for dry eye disease shows promise in treating ...

0.03 mg and 0.06 mg dosages of varenicline for patients with dry eye showed statistically significant greater improvements in tear film production.

Varenicline (TYRVAYA) Nasal Spray

Outcomes in the ONSET trials include assessment of Schirmer's test score (STS) with anesthesia and Eye Dryness Score. (Visual Analog Scale) (EDS-VAS). MYSTIC ...

Varenicline (nasal route) - Side effects & dosage

Varenicline nasal spray is used to treat signs and symptoms of dry eye disease. ... Safety and efficacy have not been established.