Clinical trial
A Phase 4, Single-Center, Open-Label Study Evaluating the Safety of the Tyrvaya Nasal Pump
Name
OPP-010
Description
The objective of this study is to determine the safety of the Tyrvaya nasal pump.
Trial arms
Trial start
2024-02-21
Estimated PCD
2024-02-28
Trial end
2024-02-28
Status
Terminated
Phase
Early phase I
Treatment
Tyrvaya Nasal Pump
Tyrvaya Nasal Pump with Silicone Lubricant
Arms:
Nasal Pump
Size
5
Primary endpoint
Incidence of Adverse Events
7 days
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:
* 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 5, 'type': 'ACTUAL'}}
Updated at
2024-04-18
1 organization
1 product
2 indications
Product
TyrvayaIndication
Dry EyeIndication
Keratoconjunctivitis siccaOrganization
Oyster Point Pharma