A Study Evaluating the Safety of the Nasal Pump

April 17, 2024 updated by: Oyster Point Pharma, Inc.

A Phase 4, Single-Center, Open-Label Study Evaluating the Safety of the Tyrvaya Nasal Pump

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Newport Beach, California, United States, 92663
        • United States, California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nasal Pump
Tyrvaya nasal pump with additional silicone lubricant
Drug: Tyrvaya Nasal Pump
Tyrvaya Nasal Pump with Silicone Lubricant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events
Time Frame: 7 days
Adverse Events with the nasal pump with additional silicone lubricant
7 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tear Film Break up Time
Time Frame: 7 days
Change from baseline in Tear Film Breakup Time. A lower time value indicates a worse outcome.
7 days
Eye Dryness Score
Time Frame: 7 days
Change from baseline in Eye Dryness Scores. EDS is collected on VAS from 0-100 with a lower score indicating a better outcome.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oyster Point Pharma, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2024

Primary Completion (Actual)

February 28, 2024

Study Completion (Actual)

February 28, 2024

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPP-010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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