临床试验/NCT06329687

NCT06329687终止4 期

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

Oyster Point Pharma, Inc.1 个研究点分布在 1 个国家目标入组 5 人开始时间: 2024年2月21日最近更新: 2025年5月2日

适应症

干预措施

试验速览

阶段: 4 期
状态: 终止
发起方: Oyster Point Pharma, Inc.
入组人数: 5
试验地点: 1
主要终点: Number of Participants With Adverse Events

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Be at least 18 years of age
•Have provided verbal and written informed consent
•Willing to comply with all study related visits and procedures

排除标准

•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.

研究组 & 干预措施

Nasal Pump

Experimental

Tyrvaya nasal pump with additional silicone lubricant

干预措施: Tyrvaya Nasal Pump (Drug)

结局指标

主要结局

Number of Participants With Adverse Events

时间窗: 7 days

Number of Participants with Adverse Events with the nasal pump with additional silicone lubricant

次要结局

未报告次要终点

研究者

发起方

Oyster Point Pharma, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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