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OpenTrials
Completed

NCT Number: NCT05918406

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

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

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Key information

Conditions

Dry Eye Conjunctival Diseases Conjunctivitis Corneal Diseases Dry Eye Syndromes Eye Diseases Keratitis Keratoconjunctivitis Keratoconjunctivitis Sicca Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

United States, New Jersey, Edison, New Jersey, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • None

Treatment and study plan

Nasal Guide

Combination Product

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

Primary outcomes

  1. Number of Participants With Adverse Events

    Time frame: 7 days

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

Sponsors and collaborators

Lead sponsor

Oyster Point Pharma, Inc.

Industry

Registry information

Official study title

A Phase 4, Single Center, Open Label Study Evaluating the Safety of the Nasal Guide Utilized During Administration With Tyrvaya

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 26, 2023
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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