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NCT05918406 Clinical Trial

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

Dry Eye Clinical Trial

Official title:
A Phase 4, Single Center, Open Label Study Evaluating the Safety of the Nasal Guide Utilized During Administration With Tyrvaya

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05918406
Other study ID # OPP-009
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 14, 2023
Est. completion date August 18, 2023

Study information
Verified date August 2023
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 nasal guide when utilized to aid in the administration of Tyrvaya (varenicline solution 0.03mg) Nasal Spray

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date August 18, 2023
Est. primary completion date August 18, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Combination Product:
• Nasal Guide
Use of Nasal Guide with administration of Tyrvaya (varenicline solution 0.03 mg) BID

Locations
Country Name City State
United States United States, New Jersey Edison New Jersey
United States United States, New Jersey Woodland Park New Jersey

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
Primary Incidence of Adverse Events Adverse Events with use of the nasal guide 7 days
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