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

NCT05378945 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2023-04-25

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Varenicline Tartrate Nasal Spray

Intranasal delivery of OC-01 (varenicline solution) 0.6 mg/mL twice a day (BID) for 28 days

DRUG

Placebo (vehicle)

Intranasal delivery of placebo (vehicle) twice a day (BID) for 28 days

Sponsors & Collaborators

  • Oyster Point Pharma, Inc.

    collaborator INDUSTRY

  • Corxel Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • JIE, Doctor · Beijing Tongren Hospital

  • DING · Corxel Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-22
Primary Completion
2023-04-04
Completion
2023-04-04
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05378945 on ClinicalTrials.gov