Actively Recruiting
The Impact of Varenicline Nasal Spray 0.03mg Dry Eye Treatment on Ocular Surface Health, Tear Film Stability, and Ocular Discomfort
Led by University of California, Berkeley · Updated on 2026-05-27
65
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of California, Berkeley
Lead Sponsor
V
Viatris Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to study the effects of a nasal spray treatment on the function of Meibomian glands and the health of the eye surface in people with dry eye symptoms caused by mild to moderate Meibomian gland dysfunction (MGD). Dry eye disease happens when the eyes do not produce enough tears or the tears evaporate quickly, leading to discomfort such as dryness, burning, irritation, and blurred vision. The nasal spray being studied is already FDA approved for treating signs and symptoms of dry eye disease. Participants in the study will use a nasal spray containing varenicline at a dose of 0.03 mg per spray. They will self-administer one spray in each nostril twice daily, about 12 hours apart, for a total of three months. This treatment period is the main phase of the study during which the effects of the nasal spray on the eye surface and tear film will be evaluated. During the study, participants will undergo assessments at the start, one month, and three months to measure changes in tear lipid layer thickness, tear thinning rate, Meibomian gland function, tear production rate, tear breakup time, and ocular comfort. These evaluations include eye exams and questionnaires to monitor the impact of the treatment on dry eye symptoms and eye health. The study will continue until the end date in December 2026, with ongoing safety and effectiveness monitoring throughout the treatment period.
CONDITIONS
Brief Title
Ocular Surface Health and Tear Film Stability With a Nasal Spray Dry Eye Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Is 18 years of age and has full legal capacity to volunteer (no maximum age requirement)
- Baseline Ocular Surface Disease Index (OSDI) greater than 13
- Has mild to moderate Meibomian gland dysfunction (MGD)
- Has best corrected visual acuity of 20/40 or better
- Has had an eye examination within the last two years
- Is willing to continue other daily dry eye management like warm compresses or eyelid cleaning
- Is willing to stop other prescription dry eye medications during the study
- Is willing to stop any topical eye drops before study visits
- Has read, understood, and signed the informed consent form
You will not qualify if you...
- Is currently participating in any other clinical or research study
- Is pregnant, nursing, lactating, or planning pregnancy
- Has more than 50% blockage in Meibomian glands in more than two eyelids or severe gland atrophy
- Is currently using any topical eye medications
- Has chronic or active sinus problems
- Has blepharitis greater than grade 1
- Has active eye infections
- Has any condition that may pose significant risk or interfere with study participation
- Has received prescription dry eye treatment within one week before enrollment
- Has received thermal or light-based dry eye treatment within 30 days before enrollment
- Has significant corneal epithelial defects
- Has abnormal eyelid anatomy
- Has corneal neuropathic pain
- Has chronic or recurring nosebleeds or bleeding disorders
- Has had eye surgery within specified recent timeframes, including intraocular or extraocular surgery
- Has a known allergy to any product used in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants will use varenicline nasal spray by self-administering one spray in each nostril twice daily for 3 months.
Visits at baseline, 1 month, and 3 months for assessments
Trial Site Locations
Total: 1 location
1
U.C. Berkeley Clinical Research Center
Berkeley, California, United States, 94720
Actively Recruiting
Research Team
M
Meng C. Lin, OD, PhD
L
Laimeng Lee, OD, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here