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

Primary Purpose

Dry Eye, Keratoconjunctivitis Sicca

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nasal Guide
Sponsored by
Oyster Point Pharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: None

Sites / Locations

  • United States, New Jersey
  • United States, New Jersey

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nasal Guide

Arm Description

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

Outcomes

Primary Outcome Measures

Incidence of Adverse Events
Adverse Events with use of the nasal guide

Secondary Outcome Measures

Full Information

First Posted
June 15, 2023
Last Updated
August 28, 2023
Sponsor
Oyster Point Pharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05918406
Brief Title
Phase 4 Study Evaluating the Safety of the Nasal Guide With Tyrvaya
Official Title
A Phase 4, Single Center, Open Label Study Evaluating the Safety of the Nasal Guide Utilized During Administration With Tyrvaya
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 14, 2023 (Actual)
Primary Completion Date
August 18, 2023 (Actual)
Study Completion Date
August 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oyster Point Pharma, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye, Keratoconjunctivitis Sicca

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Nasal guide will be used to aid in the administration of Tyrvaya® (varenicline solution 0.03 mg) Nasal Spray
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nasal Guide
Arm Type
Experimental
Arm Description
Use of Nasal Guide with administration of Tyrvaya (varenicline solution 0.03 mg) BID
Intervention Type
Combination Product
Intervention Name(s)
Nasal Guide
Intervention Description
Use of Nasal Guide with administration of Tyrvaya (varenicline solution 0.03 mg) BID
Primary Outcome Measure Information:
Title
Incidence of Adverse Events
Description
Adverse Events with use of the nasal guide
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marian Macsai, MD
Organizational Affiliation
Oyster Point Pharma
Official's Role
Study Director
Facility Information:
Facility Name
United States, New Jersey
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08820
Country
United States
Facility Name
United States, New Jersey
City
Woodland Park
State/Province
New Jersey
ZIP/Postal Code
07424
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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