Ocular Surface Health and Tear Film Stability With a Nasal Spray Dry Eye Treatment
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Berkeley
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Varenicline 0.03Mg/Spray Nasal Soln
DrugAfter 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
Treatment groups
65 Participants
are divided into 1 treatment groupGroup A: Nasal Spray Treatment GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Measured at baseline, 1-month, and 3 months2
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
Time frame
Measured at baseline, 1-month, and 3 monthsSecondary outcomes
1
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.
Time frame
Measured at baseline, 1-month, and 3 months2
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.
Time frame
Measured at baseline, 1-month, and 3 months3
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.
Time frame
Measured at baseline, 1-month, and 3 months4
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.
Time frame
Measured at baseline, 1-month, and 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Berkeley
Lead sponsor
Viatris Inc.
Collaborator
Source ClinicalTrials.gov