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

Oyster Point Pharma, Inc.30 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dry Eye Keratoconjunctivitis Sicca

Interventions

Nasal GuideCOMBINATION_PRODUCT

Use of Nasal Guide with administration of Tyrvaya (varenicline solution 0.03 mg) BID

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

United States, New Jersey

Edison, New Jersey, United States

United States, New Jersey

Woodland Park, New Jersey, United States

Outcomes

Primary Outcomes

Number of Participants With Adverse Events

Number of Participants with Adverse Events with use of the nasal guide

Time frame: 7 days

Data from ClinicalTrials.gov

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