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

NCT03097614 | Completed Results FDA Device

• 1 other identifier: OCUN-029
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Eye; Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

TrueTear

EXPERIMENTAL

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

Device: TrueTear

Interventions

TrueTear DEVICE

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

TrueTear

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oculeve, Inc.: lead

Study Sites (1)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Allergan Sales LLC

IR-CTRegistration@allergan.com

877-277-8566

Study Officials

• Gail Torkildsen, MD

  Andover Eye Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: March 31, 2017
• Study Start: March 31, 2017
• Primary Completion: June 26, 2017
• Study Completion: June 26, 2017
• Last Updated: October 18, 2018
• Results First Posted: July 19, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)