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

Oyster Point Pharma

Status and phase: Completed; Phase 4

Conditions: Dry Eye; Keratoconjunctivitis Sicca

Treatments: Combination Product: Nasal Guide

Study type: Interventional

Funder types: Industry

Identifiers

NCT05918406

OPP-009

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Nasal Guide

Experimental group

Description:

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

Treatment:

Combination Product: Nasal Guide