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

Phase 4

Completed

• Conditions: Dry Eye; Keratoconjunctivitis Sicca

• Registration Number: NCT05918406
• Lead Sponsor: Oyster Point Pharma, Inc.

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.

Study Timeline

• Study Start: 2023-06-14
• Study First Submitted: 2023-06-15
• Study First Submitted QC: 2023-06-15
• Study First Posted: 2023-06-26
• Primary Completion: 2023-08-18
• Study Completion: 2023-08-18
• Status Verified: 2025-03
• Results First Submitted: 2025-03-24
• Results First Submitted QC: 2025-05-01
• Last Update Submitted: 2025-05-01
• Results First Posted: 2025-05-06
• Last Update Posted: 2025-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	7 days	Number of Participants with Adverse Events with use of the nasal guide

Trial Locations

Locations (1)

United States, New Jersey; 🇺🇸 Woodland Park, New Jersey, United States