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Nicotinic Acetylcholine Receptor Partial Agonist

Varenicline solution for Dry Eye Syndrome(TSUNAMI Trial)

Stephenson Eye Associates, Venice, FL
Varenicline solution +1 morePhase 4RecruitingResearch Sponsored by Stephenson Eye Associates

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 Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You have a score of 13 or higher on a test that measures how dry your eyes feel.

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

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.

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How large is the cohort of individuals being examined in this clinical trial?

"Affirmative. The information hosted on clinicaltrials.gov highlights that this medical trial, which was initially posted on August 29th 2022, is actively seeking participants. Sixty patients have to be brought in from one site for the study to proceed as planned."

Answered by AI

Has the FDA sanctioned Varenicline solution for use?

"Varenicline solution has been approved, so it scored a 3 on our team's safety scale."

Answered by AI

Does this experiment presently require volunteers?

"Affirmative. According to clinicaltrials.gov, this medical research is presently recruiting volunteers who initially saw the study posted on August 29th of 2022 and was subsequently updated on the 23rd of that same month. A total of 60 people are being sought out from a single location for participation."

Answered by AI

Who else is applying?

What site did they apply to?
Stephenson Eye Associates
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
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
2022. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05514041.
All > Dry Eye > Chantix
~27 spots leftby Dec 2024
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