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Nicotinic Acetylcholine Receptor Partial Agonist

A Randomized, Controlled, Double-masked, Investigator-initiated Trial to Evaluate Tear Film Quality and Stability in Subjects With Dry Eye Disease Using OC-01 (Varenicline Solution) Nasal Spray 0.03 mg as Compared to Vehicle Control Nasal Spray (TSUNAMI Trial)

Phase 4
Waitlist Available
Research Sponsored by Stephenson Eye Associates
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1/day 28
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial is testing a nasal spray containing varenicline to help people with dry eye disease. The spray works by stimulating nerves to increase tear production. The goal is to see if this treatment can improve tear film quality and stability. Varenicline nasal spray (Tyrvaya) has been approved by the FDA for the treatment of dry eye disease and has shown efficacy in increasing tear production in clinical trials.

Eligible Conditions
  • Dry Eye Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1/day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1/day 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Surface qualifier image change
Secondary study objectives
Change from baseline in surface qualifier image analysis
Corneal fluorescein staining score
EDS
+5 more
Other study objectives
AEs
Exploratory analysis of change in Cassini

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: OC-01 (varenicline solution) nasal spray 0.03 mgExperimental Treatment1 Intervention
Subjects will be randomized 1:1 to be treated with the agent delivered as a 0.05 mL intranasal spray in each nostril at the following formulations
Group II: Placebo nasal spray (OC-01 Vehicle Nasal Spray)Placebo Group1 Intervention
Subjects will be randomized 1:1 to be treated with the agent delivered as a 0.05 mL intranasal spray in each nostril at the following formulations

Find a Location

Who is running the clinical trial?

Stephenson Eye AssociatesLead Sponsor
~18 spots leftby Dec 2025
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