NCT03097614

Dry Eye Symptom Relief Assessment With Use of TrueTear in a Controlled Adverse Environment

Prospective, Single-Arm Clinical Trial to Evaluate Acute Dry Eye Symptom Relief Assessed During Exposure to a Controlled Adverse Environment (CAE®) Following a 45 Day Period With Application of TrueTear™

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Oculeve, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

This study characterizes acute dry eye symptom control, assessed during exposure to a Controlled Adverse Environment, following use of the TrueTear for 45 days.

Detailed description

Subjects will be instructed to use the TrueTear daily for approximately 45 days with assessments in the Controlled Adverse Environment taking place on Day 0 and Day 45. Upon entering the CAE, participants will complete dry eye symptom questionnaires every five minutes and will administer the device when a certain level of ocular discomfort has been reached.

Conditions

• Dry Eye
• Dry Eye Syndromes

Interventions

Type	Name	Description
DEVICE	TrueTear	The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.

Timeline

• Start date: 2017-03-31
• Primary completion: 2017-06-26
• Completion: 2017-06-26
• First posted: 2017-03-31
• Last updated: 2018-10-18
• Results posted: 2018-07-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study