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Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of OC-01 in Adult Chinese With Dry Eye Disease

NCT05576415 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-05-01

No results posted yet for this study

Summary

The objective of this study is to evaluate the pharmacokinetics (PK) in adult Chinese subjects with dry eye disease (DED)1 after bilateral nasal spray administration of OC-01 (varenicline solution) Nasal Spray at a concentration of 0.6 mg/mL.

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.

Sponsors & Collaborators

  • Oyster Point Pharma, Inc.

    collaborator INDUSTRY

  • Corxel Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • LU, Doctor · Huashan Hospital

  • ZHANG, Doctor · Huashan Hospital

  • DING · Corxel Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-07
Primary Completion
2023-04-27
Completion
2023-04-27
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 NCT05576415 on ClinicalTrials.gov