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

Dry Eye Clinical Trial

Official title:

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™

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03097614
• Other study ID #: OCUN-029
• Status: Completed
• Phase: N/A
• Start date: March 31, 2017
• Est. completion date: June 26, 2017

Study information

• Verified date: September 2018
• Source: Oculeve, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT03180047

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: June 26, 2017
• Est. primary completion date: June 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to the Screening Visit

• Normal lid/lash anatomy, blinking function and closure as determined by the Investigator

• Literate, able to speak English, and able to complete questionnaires independently

Exclusion Criteria:

• Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the Investigator, may lead to risk of clinically significant increased bleeding

• Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas

• Contact lens use within 7 days prior to the Screening Visit or anticipate the use of contact lenses at any time during the study

• Corneal transplant in either or both eyes

• Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or active implanted electronic device in the head

• A woman who is pregnant, nursing an infant, or planning a pregnancy during the duration of the study

• Currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to the Screening Visit

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Device:
• TrueTear
The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Oculeve, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eye Dryness Score	Eye Dryness Score using a visual analog scale assessed in the Controlled Adverse Environment (CAE). The participant rates their current eye dryness (both eyes simultaneously) by scoring 0 to indicate "no discomfort" and 100 to indicate "maximal discomfort". The assessment line length of the scale will be 100 mm.	Day 45