Phase 4 Study Evaluating the Safety of the Nasal Guide With Tyrvaya
Phase 4
Completed
- Conditions
- Dry EyeKeratoconjunctivitis Sicca
- Interventions
- Combination Product: Nasal Guide
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nasal Guide Nasal Guide Use of Nasal Guide with administration of Tyrvaya (varenicline solution 0.03 mg) BID
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
United States, New Jersey
🇺🇸Woodland Park, New Jersey, United States