Clinical trial
A Phase 4, Single Center, Open Label Study Evaluating the Safety of the Nasal Guide Utilized During Administration With Tyrvaya
Name
OPP-009
Description
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
Trial arms
Trial start
2023-06-14
Estimated PCD
2023-08-18
Trial end
2023-08-18
Status
Completed
Phase
Early phase I
Treatment
Nasal Guide
Use of Nasal Guide with administration of Tyrvaya (varenicline solution 0.03 mg) BID
Arms:
Nasal Guide
Size
30
Primary endpoint
Incidence of Adverse Events
7 days
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Nasal guide will be used to aid in the administration of Tyrvaya® (varenicline solution 0.03 mg) Nasal Spray', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}
Updated at
2023-08-29
1 organization
1 product
2 indications
Product
Nasal GuideIndication
Dry EyeIndication
Dry Eye SyndromeOrganization
Oyster Point Pharma