NCT05918406

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Oyster Point Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Eye
• Keratoconjunctivitis Sicca

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Nasal Guide	Use of Nasal Guide with administration of Tyrvaya (varenicline solution 0.03 mg) BID

Timeline

• Start date: 2023-06-14
• Primary completion: 2023-08-18
• Completion: 2023-08-18
• First posted: 2023-06-26
• Last updated: 2025-05-06
• Results posted: 2025-05-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study