Phase 4 Study Evaluating the Safety of the Nasal Guide With Tyrvaya

NCT ID: NCT05918406

Last Updated: 2025-05-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-14

Study Completion Date

2023-08-18

Brief Summary

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The objective of this study is to determine the safety of the nasal guide when utilized to aid in the administration of Tyrvaya (varenicline solution 0.03mg) Nasal Spray

Detailed Description

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Protocol OPP-009 is a single center, open-label study to evaluate the safety of the nasal guide during administration of Tyrvaya (varenicline solution 0.03mg) Nasal Spray. Approximately 30 subjects at least 18 years of age will be enrolled at one clinical study site and will receive the nasal guide for use with the administration of Tyrvaya for 7 days.

Conditions

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Dry Eye Keratoconjunctivitis Sicca

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Nasal guide will be used to aid in the administration of Tyrvaya® (varenicline solution 0.03 mg) Nasal Spray
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nasal Guide

Use of Nasal Guide with administration of Tyrvaya (varenicline solution 0.03 mg) BID

Group Type EXPERIMENTAL

Nasal Guide

Intervention Type COMBINATION_PRODUCT

Use of Nasal Guide with administration of Tyrvaya (varenicline solution 0.03 mg) BID

Interventions

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Nasal Guide

Use of Nasal Guide with administration of Tyrvaya (varenicline solution 0.03 mg) BID

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

1. Be at least 18 years of age
2. Have provided verbal and written informed consent
3. Willing to comply with all study related visits and procedures

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oyster Point Pharma, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marian Macsai, MD

Role: STUDY_DIRECTOR

Oyster Point Pharma

Locations

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United States, New Jersey

Edison, New Jersey, United States

Site Status

United States, New Jersey

Woodland Park, New Jersey, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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OPP-009

Identifier Type: -

Identifier Source: org_study_id

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