A Study Evaluating the Safety of the Nasal Pump

NCT ID: NCT06329687

Last Updated: 2025-05-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-21

Study Completion Date

2024-02-28

Brief Summary

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The objective of this study is to determine the safety of the Tyrvaya nasal pump.

Detailed Description

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The study is testing the hypothesis that the use of the Tyrvaya nasal pump with silicone lubricant does not introduce any additional safety concerns as compared to the safety of the Tyrvaya nasal pump without the additional silicone lubricant.

Conditions

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Dry Eye Kerato Conjunctivitis Sicca

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nasal Pump

Tyrvaya nasal pump with additional silicone lubricant

Group Type EXPERIMENTAL

Tyrvaya Nasal Pump

Intervention Type DRUG

Tyrvaya Nasal Pump with Silicone Lubricant

Interventions

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Tyrvaya Nasal Pump

Tyrvaya Nasal Pump with Silicone Lubricant

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to Visit 1.
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

Locations

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United States, California

Newport Beach, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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OPP-010

Identifier Type: -

Identifier Source: org_study_id

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