NCT05514041 (TSUNAMI) is a Phase 4 clinical trial of Varenicline solution in Dry Eye Disease, sponsored by Stephenson Eye Associates.

Who is sponsoring NCT05514041?

NCT05514041 is sponsored by Stephenson Eye Associates.

What drugs are being tested in NCT05514041?

Interventions in NCT05514041: Varenicline solution, Placebo nasal spray (OC-01 Vehicle Nasal Spray).

What condition does NCT05514041 study?

NCT05514041 studies Dry Eye Disease.

Is NCT05514041 still recruiting?

NCT05514041 is currently status unknown. Last updated 24 August 2022.

Last reviewed 2022-08-24 · How we verify

NCT05514041: TSUNAMI

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown Phase 4 Last updated 24 August 2022

What this trial tests

Phase 4 trial testing Varenicline solution in Dry Eye Disease in 60 participants. Status unknown.

Timeline

29 August 2022

Primary endpoint
1 September 2023

1 September 2023

Quick facts

Lead sponsor	Stephenson Eye Associates
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	29 August 2022
Primary completion	1 September 2023
Estimated completion	1 September 2023
Sites	1 location across United States

Drugs / interventions tested

Varenicline solution
Placebo nasal spray (OC-01 Vehicle Nasal Spray) — full drug profile →

Conditions studied

Dry Eye Disease — all drugs for Dry Eye Disease →

Sponsor

Stephenson Eye Associates — full company profile →

Who can join

22 and older, any sex, with Dry Eye Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Dry Eye Disease

Currently open trials in the same condition.

NCT06596733 — Vit-A-Vision® Clinical Investigation · NA · recruiting
NCT07264517 — Evaluating the Safety, Tolerability, and Efficacy of GRF312 5% in Participants With Dry Eye Disease (DED). · Phase 2 · recruiting
NCT07025811 — A Study to Explore Signs, Symptoms, and Biomarkers in Dry Eye Disease Participants Following Anti-inflammatory Treatment · Phase 4 · recruiting
NCT04946721 — 2177GCCC:ID'Ing tx Targets and Biomarkers for Ocular Surface Disease in Pt w/ oGVHD · recruiting
NCT06696625 — Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05514041 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Stephenson Eye Associates
Last refreshed: 24 August 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05514041.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing