NCT05918406
Completed
Phase 4
A Phase 4, Single Center, Open Label Study Evaluating the Safety of the Nasal Guide Utilized During Administration With Tyrvaya
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Dry Eye
- Sponsor
- Oyster Point Pharma, Inc.
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Number of Participants With Adverse Events
- Status
- Completed
- Last Updated
- 12 months ago
Overview
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.
Investigators
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
- Not provided
Outcomes
Primary Outcomes
Number of Participants With Adverse Events
Time Frame: 7 days
Number of Participants with Adverse Events with use of the nasal guide
Study Sites (1)
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