← Back to Search

Nicotinic Acetylcholine Receptor Partial Agonist

Varenicline solution for Dry Eye Syndrome (TSUNAMI Trial)

Phase 4
Recruiting
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

TSUNAMI Trial Summary

This trial is testing a new drug to see if it helps people with dry eye disease by improving tear film quality and stability.

Eligible Conditions
  • Dry Eye Syndrome

TSUNAMI Trial 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

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

TSUNAMI 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
~22 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top