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Recruiting NCT07606625

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

Phase IV Interventional Dry Eye Meibomian Gland Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Varenicline 0.03Mg/Spray Nasal Soln.
Who it may be relevant to
Registry conditions: Dry Eye, Meibomian Gland Dysfunction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Impact of Varenicline Nasal Spray 0.03mg Dry Eye Treatment on Ocular Surface Health, Tear Film Stability, and Ocular Discomfort

Overview

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).

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.

Interventions

  • 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

Primary outcome measures

  • 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]
Secondary outcome measures (4)
  • Change in Meibomian gland function [Time frame: Measured at baseline, 1-month, and 3 months]
  • Change in tear production rate [Time frame: Measured at baseline, 1-month, and 3 months]
  • Change in tear breakup time [Time frame: Measured at baseline, 1-month, and 3 months]
  • Change in Ocular Comfort [Time frame: Measured at baseline, 1-month, and 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • U.C. Berkeley Clinical Research Center — Berkeley

Identifiers

NCT: NCT07606625 · 15446-MCLin

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗