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

Sponsor

Oyster Point Pharma, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05918406

Collaborator

(none)

Enrollment

Locations

Arm

1.6

Anticipated Duration (Months)

Patients Per Site

9.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Keratoconjunctivitis Sicca	Combination Product: Nasal Guide	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Nasal guide will be used to aid in the administration of Tyrvaya® (varenicline solution 0.03 mg) Nasal SprayNasal guide will be used to aid in the administration of Tyrvaya® (varenicline solution 0.03 mg) Nasal Spray

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 14, 2023

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nasal Guide Use of Nasal Guide with administration of Tyrvaya (varenicline solution 0.03 mg) BID	Combination Product: Nasal Guide Use of Nasal Guide with administration of Tyrvaya (varenicline solution 0.03 mg) BID

Arm

Intervention/Treatment

Experimental: Nasal Guide

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

Combination Product: Nasal Guide

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

Outcome Measures

Primary Outcome Measures

Incidence of Adverse Events [7 days]
Adverse Events with use of the nasal guide

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	United States, New Jersey	Edison	New Jersey	United States	08820
2	United States, New Jersey	Woodland Park	New Jersey	United States	07424

Sponsors and Collaborators

Oyster Point Pharma, Inc.

Investigators

Study Director: Marian Macsai, MD, Oyster Point Pharma

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Oyster Point Pharma, Inc.

ClinicalTrials.gov Identifier:

NCT05918406

Other Study ID Numbers:

OPP-009

First Posted:

Jun 26, 2023

Last Update Posted:

Jun 27, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dry Eye Syndromes

Keratoconjunctivitis

Keratoconjunctivitis Sicca

Study Results

No Results Posted as of Jun 27, 2023