Nasal Spray Dry Eye Treatment

The Impact of Nasal Spray Dry Eye Treatment on Ocular Surface Health

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).

Study Overview

• Status: Recruiting
• Conditions: Dry Eye; Meibomian Gland Dysfunction
• Intervention / Treatment: Drug: Varenicline 0.03Mg/Spray Nasal Soln

Detailed Description

Dry eye disease is a common condition that occurs when eyes do not produce enough tears or when the quality of the tears is poor causing tears to evaporate quickly off the eye. This can lead to symptoms such as dryness, burning, irritation, and/or blurred vision. Meibomian gland dysfunction is the most common cause of evaporative dry eye disease. 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). The nasal spray is FDA approved for the treatment of signs and symptoms of dry eye disease.

• Study Type: Interventional
• Enrollment (Estimated): 65
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Meng C. Lin, OD, PhD; Phone Number: 510-643-9252; Email: mlin@berkeley.edu
• Study Contact Backup: Name: Laimeng Lee, OD, MS; Phone Number: 510-643-9252; Email: laimenglee@berkeley.edu

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94720
      • Recruiting
      • U.C. Berkeley Clinical Research Center
      • Contact: Meng C. Lin, OD, PhD; Phone Number: 510-643-9252; Email: mlin@berkeley.edu
      • Contact: Laimeng Lee, OD, MS; Phone Number: 510-643-9252; Email: laimenglee@berkeley.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in tear lipid layer thickness	Change from baseline in the thickness of the tear lipid layer in microns measured using the EASYTEARView+ Dacryscope. An increase in tear lipid layer thickness is considered a positive treatment effect	Measured at baseline, 1-month, and 3 months
Change in tear thinning rate	Change from baseline in the rate of tear thinning in %/sec measured using the EASYTEARView+ Dacryscope. A decrease in the rate of tear thinning is considered a positive treatment effect	Measured at baseline, 1-month, and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Meibomian gland function	Change from baseline in the clinical grade of meibum expressed from the Meibomian glands using the Korb Meibomian Gland Evaluator. Clinical grades assigned based on a 0-30 point scale, with 30 indicating copious, clear meibum and 0 indicating no meibum expressed (blocked orifices). An increase in score indicates improved gland function.	Measured at baseline, 1-month, and 3 months
Change in tear production rate	Change from baseline in the rate of tear production in µL/min, measured using the Schirmer Tear Test. An increase in tear production is considered a positive treatment effect.	Measured at baseline, 1-month, and 3 months
Change in tear breakup time	Change from baseline in non-invasive tear breakup time in seconds, measured using the Oculus Keratograph 5M. An increase in tear breakup time is considered a positive treatment effect.	Measured at baseline, 1-month, and 3 months
Change in Ocular Comfort	Change from baseline in ocular discomfort, measured using the Ocular Surface Disease Index (OSDI) on a 0-100 scale. A decrease in OSDI score is considered a positive treatment effect.	Measured at baseline, 1-month, and 3 months

Collaborators and Investigators

• Sponsor: University of California, Berkeley
• Collaborators: Viatris Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 19, 2026
• First Submitted That Met QC Criteria: May 19, 2026
• First Posted (Actual): May 26, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Dry eye, Meibomian gland dysfunction, nasal spray treatment
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Eyelid Diseases; Meibomian Gland Dysfunction; Dry Eye Syndromes; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzazepines; Quinoxalines; Varenicline
• Other Study ID Numbers: 15446-MCLin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data are considered proprietary intellectual property of Viatris, Inc.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No