Nasal spray eye treatment to help dry eye with meibomian gland dysfunction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4 interventional trial investigates the effect of a varenicline nasal spray on ocular surface health and meibomian gland function in adults with symptomatic dry eye and mild to moderate meibomian gland dysfunction. Participants will use the nasal spray and continue usual dry eye care, with assessments of tear film stability, symptoms, and gland function over time. The study is conducted at the UC Berkeley Clinical Research Center, with Viatris Inc. as a collaborator, under an FDA-approved indication for dry eye signs and symptoms. Primary outcomes focus on changes in ocular surface measures and meibomian gland function, alongside patient-reported symptoms. Safety and tolerability of the nasal spray will be monitored throughout.

Why it matters

Who can join: the full rules

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

Where it's running

• U.C. Berkeley Clinical Research Center
  Berkeley, California, United States Recruiting

Study contacts

• Study coordinator: Meng C. Lin, OD, PhD
• Email: mlin@berkeley.edu
• Phone: 510-643-9252

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.