Clinical Trials Logo
  1. Home
  2. Dry Eye
  3. NCT06329687
  4. Details
NCT06329687 Clinical Trial

A Study Evaluating the Safety of the Nasal Pump

Dry Eye Clinical Trial

Official title:
A Phase 4, Single-Center, Open-Label Study Evaluating the Safety of the Tyrvaya Nasal Pump

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT06329687
Other study ID # OPP-010
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date February 21, 2024
Est. completion date February 28, 2024

Study information
Verified date March 2024
Source Oyster Point Pharma, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to determine the safety of the Tyrvaya nasal pump.

Description:

The study is testing the hypothesis that the use of the Tyrvaya nasal pump with silicone lubricant does not introduce any additional safety concerns as compared to the safety of the Tyrvaya nasal pump without the additional silicone lubricant.

Recruitment information / eligibility
Status Terminated
Enrollment 5
Est. completion date February 28, 2024
Est. primary completion date February 28, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tyrvaya Nasal Pump
Tyrvaya Nasal Pump with Silicone Lubricant

Locations
Country Name City State
United States United States, California Newport Beach California

Sponsors (1)
Lead Sponsor Collaborator
Oyster Point Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Tear Film Break up Time Change from baseline in Tear Film Breakup Time. A lower time value indicates a worse outcome. 7 days
Other Eye Dryness Score Change from baseline in Eye Dryness Scores. EDS is collected on VAS from 0-100 with a lower score indicating a better outcome. 7 days
Primary Incidence of Adverse Events Adverse Events with the nasal pump with additional silicone lubricant 7 days
See also
  Status Clinical Trial Phase
Completed NCT05102409 - An Exploratory Clinical Trial to Assess Safety and Tolerability in Subjects With Dry Eye Disease Phase 2
Completed NCT05027087 - The Effect of a Novel Blueberry Supplement on Dry Eye Disease Phase 3
Completed NCT06159569 - Performance and Tolerability of the Medical Device LACRIACT N/A
Completed NCT04081610 - Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution Phase 1
Completed NCT05062564 - Efficacy of LipiFlow in Patients Affected by Meibomian Gland Dysfunction in Reducing Post-cataract Surgery Dry Eye N/A
Completed NCT05825599 - PMCF Study to Evaluate Performance and Safety of "HPMC-based Eyedrops" Used to Relieve Dry Eye Symptoms N/A
Completed NCT03418727 - Dry Eye Disease Study With Brimonidine Phase 2
Active, not recruiting NCT04425551 - Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction N/A
Recruiting NCT04527887 - Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease (DEcIDED) Phase 4
Not yet recruiting NCT06379685 - Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface. Phase 1
Active, not recruiting NCT05618730 - Safety, Tolerability, Plug Retention and Preliminary Efficacy of Tacrolimus-loaded Punctal Plug in Patients With Moderate to Severe Dry Eye Disease - Cohort B Phase 1
Completed NCT04553432 - Dry Eye OmniLenz Application of Omnigen Research Study Phase 4
Recruiting NCT04109170 - Dry Eye Evaluation System Based on Bioinformatics
Completed NCT04105842 - Refitting Daily Disposable Contact Lens Wearers With Dry Eye Disease With A Different Daily Disposable Lens Type N/A
Completed NCT05505292 - Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers Phase 4
Completed NCT04668131 - Study on Curative Effect and Mechanism of Acupuncture on Neuropathic Pain in Dry Eye Disease N/A
Completed NCT06176651 - Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in Habitual Contact Lens Wearers Phase 4
Not yet recruiting NCT02218827 - Topical Steroid Treatment For Dry Eye N/A
Completed NCT02235259 - Efficacy and Safety of XG-104 for the Treatment of Dry Eye Phase 2
Completed NCT01959854 - Efficacy of Topical 0.2% Xanthan Gum in Patients With Dry Eye N/A