Who is sponsoring NCT05378945?

NCT05378945 is sponsored by Corxel Pharmaceuticals.

What drugs are being tested in NCT05378945?

Interventions in NCT05378945: Varenicline Tartrate Nasal Spray, Placebo (vehicle).

What condition does NCT05378945 study?

NCT05378945 studies Dry Eye Disease.

Is NCT05378945 still recruiting?

NCT05378945 is currently completed. Last updated 25 April 2023.

Last reviewed 2023-04-25 · How we verify

NCT05378945

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

Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease

Completed Phase 3 Last updated 25 April 2023

What this trial tests

Phase 3 trial testing Varenicline Tartrate Nasal Spray in Dry Eye Disease in 340 participants. Completed in 4 April 2023.

Timeline

22 July 2022

Primary endpoint
4 April 2023

4 April 2023

Quick facts

Lead sponsor	Corxel Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	340
Start date	22 July 2022
Primary completion	4 April 2023
Estimated completion	4 April 2023
Sites	20 locations across China

Drugs / interventions tested

Varenicline Tartrate Nasal Spray — full drug profile →
Placebo (vehicle)

Conditions studied

Dry Eye Disease — all drugs for Dry Eye Disease →

Sponsor

Corxel Pharmaceuticals — full company profile →

Who can join

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

Sponsor's own description

The objective of this study is to evaluate the safety and effectiveness of OC-01 (varenicline solution) Nasal Spray as compared to placebo (vehicle) on signs and symptoms of dry eye disease.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Varenicline solution nasal spray for dry eye disease in Chinese patients: a randomized phase 3 trial.
Tian L, Jin X, Wang J, Xu Y, et al · · 2024 · cited 2× · PMID 38440130 · DOI 10.1016/j.lanwpc.2024.101032

Verify or expand the search:

Other trials of Varenicline Tartrate Nasal Spray

Trials testing the same drug.

NCT05576415 — Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of OC-01 in Adult Chinese With Dry Eye Disease · Phase 1 · completed

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

Other Corxel Pharmaceuticals trials

Trials by the same sponsor.

NCT07340320 — A Study of CX11 Tablets in Patients With Type 2 Diabetes Mellitus · Phase 2 · recruiting
NCT07011797 — A Study to Evaluate the Efficacy and Safety of CX11 Tablets in Overweight/Obese Participants · Phase 2 · active not recruiting
NCT06990867 — Optimizing Reperfusion to Improve Outcomes and Neurologic Function · Phase 2, PHASE3 · recruiting
NCT06270030 — Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Chinese With Presby · Phase 1 · completed
NCT06116968 — An Open-Label Study of Aficamten for Chinese Patients With Symptomatic oHCM · Phase 3 · completed

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 NCT05378945 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Corxel Pharmaceuticals
Last refreshed: 25 April 2023

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/NCT05378945.

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