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NCT06329687 Clinical Trial

A Study Evaluating the Safety of the Nasal Pump

Dry Eye Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT06329687
Other study ID # OPP-010
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date February 21, 2024
Est. completion date February 28, 2024

Study information
Verified date March 2024
Source Oyster Point Pharma, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 5
Est. completion date February 28, 2024
Est. primary completion date February 28, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tyrvaya Nasal Pump
Tyrvaya Nasal Pump with Silicone Lubricant

Locations
Country Name City State
United States United States, California Newport Beach California

Sponsors (1)
Lead Sponsor Collaborator
Oyster Point Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Tear Film Break up Time Change from baseline in Tear Film Breakup Time. A lower time value indicates a worse outcome. 7 days
Other Eye Dryness Score 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
Primary Incidence of Adverse Events Adverse Events with the nasal pump with additional silicone lubricant 7 days
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