A Study Evaluating the Safety of the Nasal Pump

Phase 4

Terminated

• Conditions: Kerato Conjunctivitis Sicca; Dry Eye
• Interventions: Drug: Tyrvaya Nasal Pump

• Registration Number: NCT06329687
• Lead Sponsor: Oyster Point Pharma, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2024-02-21
• Primary Completion: 2024-02-28
• Study Completion: 2024-02-28
• Status Verified: 2024-03
• Study First Submitted: 2024-03-19
• Study First Submitted QC: 2024-03-19
• Study First Posted: 2024-03-26
• Results First Submitted: 2025-03-24
• Results First Submitted QC: 2025-04-16
• Last Update Submitted: 2025-04-16
• Results First Posted: 2025-05-02
• Last Update Posted: 2025-05-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nasal Pump	Tyrvaya Nasal Pump	Tyrvaya nasal pump with additional silicone lubricant

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	7 days	Number of Participants with Adverse Events with the nasal pump with additional silicone lubricant

Trial Locations

Locations (1)

United States, California; 🇺🇸 Newport Beach, California, United States