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Evaluation of the Efficacy and Safety of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease

NCT04036292 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 758

Last updated 2021-11-22

Study results available
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Summary

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

Conditions

  • Dry Eye Disease (DED)

Interventions

DRUG

OC-01 (varenicline) nasal spray

OC-01 (varenicline) nasal spray

DRUG

Placebo (vehicle) nasal spray

Placebo (vehicle) nasal spray

Sponsors & Collaborators

  • Oyster Point Pharma, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-23
Primary Completion
2020-04-10
Completion
2021-02-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04036292 on ClinicalTrials.gov