Recruiting

Nasal SprayOcular Surface Health and Tear Film Stability With a Nasal Spray Dry Eye Treatment

Sponsor:

UCLA

Code:

NCT07606625

Conditions

Dry Eye

Meibomian Gland Dysfunction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Varenicline 0.03Mg/Spray Nasal Soln

Study Details

Brief summary:

The purpose of this study is to examine the impact of nasal spray treatment on Meibomian gland function and ocular surface health in symptomatic dry eye patients with mild to moderate Meibomian gland dysfunction (MGD).

Conditions

Dry Eye

Meibomian Gland Dysfunction

Study ID

NCT07606625

Start date

Mar 6, 2026

Status verified date

May, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Is 18 years of age and has full legal capacity to volunteer (no max age requirement)
Baseline Ocular Surface Disease Index (OSDI) >13
Has mild to moderate MGD
Has best corrected visual acuity of 20/40 or better
Has had an oculo-visual examination in the last two years
Is willing to continue other daily dry eye management regimen (e.g., warm compresses, and/or eyelid margin cleaning)
Is willing to discontinue other prescription medications for dry eye disease (DED) management
Is willing to stop any topical eye drops before all planned visits
Has read, understood, and completed the informed consent letter

Exclusion Criteria:

Is participating in any other type of clinical or research study
Is currently pregnant, nursing, lactating, or planning a pregnancy
Is currently having >50% blockage of Meibomian glands in more than two eyelids or significant atrophy (i.e., severe MGD)
Is currently using any topical ocular medications
Has chronic or currently active sinus related problems
Has blepharitis > grade 1
Has active ocular infections
Has 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 in the study
Has received Rx DED treatment within one week of enrollment
Has received any thermal or light-based DED treatment within 30 days of enrollment
Has significant corneal epithelial defects
Has abnormal eyelid anatomy
Has corneal neuropathic pain
Has chronic or recurrent epistaxis (nosebleeds), coagulation disorders, or other conditions that may have led to a clinically significant increased risk of bleeding
Has any intraocular surgery including trabeculectomy (MIGS, laser, or small incision glaucoma surgery allowed), extraocular surgery in either eye within 3 months, or refractive surgery within 12 months of enrollment
Has a known allergy to a product used in this study

Study Design

Enrollment

65 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Nasal Spray Treatment Group

Participants to be dispensed varenicline nasal spray 0.03mg solution and self-administer one spray in each nostril twice daily, approximately 12 hours apart, for 3 months.

Interventions

Varenicline 0.03Mg/Spray Nasal Soln

After meeting eligibility criteria and signing informed consent, participants will be dispensed a 3-month supply of varenicline 0.03mg/spray nasal solution. Participants will take the nasal spray home and spray once in each nostril twice daily for 3 months

Primary outcome measure

Change in tear lipid layer thickness [ Time Frame: Measured at baseline, 1-month, and 3 months ]
Change in tear thinning rate [ Time Frame: Measured at baseline, 1-month, and 3 months ]

Central Contacts and Locations

Central contacts

Meng C. Lin, OD, PhD

510-643-9252 mlin@berkeley.edu

Laimeng Lee, OD, MS

510-643-9252 laimenglee@berkeley.edu

Locations

U.C. Berkeley Clinical Research Center

Recruiting

Berkeley, California, United States, 94720

Contacts

Meng C. Lin, OD, PhD

510-643-9252 mlin@berkeley.edu

Laimeng Lee, OD, MS

510-643-9252 laimenglee@berkeley.edu

More Information

Sponsor

University of California, Berkeley

Last update posted

May 27, 2026

Last verified

May, 2026

Keywords

Dry eye disease
Meibomian gland dysfunction
Varenicline
Nasal spray dry eye treatment
Tear lipid layer
Tear thinning
Tear production
Tear film stability
Ocular discomfort

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-14. This information was provided to ClinicalTrials.gov by University of California, Berkeley on 2026-05-27.