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

NCT07606625 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 15446-MCLin
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change in Meibomian gland function

  Measured at baseline, 1-month, and 3 months

• Change in tear production rate

  Measured at baseline, 1-month, and 3 months

• Change in tear breakup time

  Measured at baseline, 1-month, and 3 months

• Change in Ocular Comfort

  Measured at baseline, 1-month, and 3 months

Study Arms (1)

Nasal Spray Treatment Group

EXPERIMENTAL

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

Interventions

Varenicline 0.03Mg/Spray Nasal Soln DRUG

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

Nasal Spray Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Berkeley: lead
• Viatris Inc.: collaborator

Study Sites (1)

U.C. Berkeley Clinical Research Center

Berkeley, California, 94720, United States

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction; Lacerations

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Eyelid Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Central Study Contacts

Meng C. Lin, OD, PhD

CONTACT

510-643-9252; mlin@berkeley.edu

Laimeng Lee, OD, MS

CONTACT

510-643-9252; laimenglee@berkeley.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start: March 6, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)