Evaluation of Dry Eye Symptoms in CAE With Application of Intranasal Neurostimulation

NCT02910713 | Completed Results FDA Device

• 1 other identifier: OCUN-011
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 3

Brief Summary

This study evaluates the safety and effectiveness of the Intranasal Tear Neurostimulator applied intranasally (active) compared with the same device applied extranasally (control) relating to symptoms of dry eye exacerbated by the Controlled Adverse Environment model.

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• Change From Pre-Application to Post-Application in Eye Dryness Score (EDS) Using a Visual Analog Scale (VAS)

  The participant rated their eye dryness (both eyes simultaneously) at all visits and every 5 minutes during CAE exposure by placing a vertical mark on the 100 mm horizontal line to indicate the level of eye dryness. 0 corresponds to "no dryness" and 100 corresponds to "maximal dryness". A negative change from Baseline indicates improvement. A cross-over linear model was used with symptom relief as the response variable; sequence, application location, period, and the application location by period interaction as fixed effects; and participant (sequence) as a random effect.

  Pre-application to Post-application on Day 0

Secondary Outcomes (1)

• Change From Pre-Application to Post-Application in the Ora Calibra Ocular Discomfort Scale (ODS) Score

  Pre-application to Post-application on Day 0

Study Arms (2)

Intranasal Application

EXPERIMENTAL

Intranasal Tear Neurostimulator applied intranasally device (active), intranasal application for approximately 3 minutes on Day 0 when the participant experienced an ODS ≥ 3 at 2 or more consecutive time points in at least one eye during the CAE exposure.

Device: Intranasal Tear Neurostimulator

Extranasal Application

SHAM COMPARATOR

Intranasal Tear Neurostimulator device applied extranasally (control) for approximately 3 minutes on Day 0 when the participant experienced an ODS ≥ 3 at 2 or more consecutive time points in at least one eye during the CAE exposure.

Device: Intranasal Tear Neurostimulator

Interventions

Intranasal Tear Neurostimulator DEVICE

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

Extranasal Application; Intranasal Application

Eligibility Criteria

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

You may qualify if:

• Moderate to severe dry eye disease
• 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
• Implanted metallic or electronic device in the head, a cardiac demand pacemaker, or an implanted defibrillator
• Corneal transplant in either or both eyes
• A woman who is pregnant, nursing an infant, or planning a pregnancy at the Screening Visit
• Be 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

• Allergan: lead

Study Sites (3)

Eye Care Institute

Louisville, Kentucky, 40206, United States

Location

Total Eye Care, PA

Memphis, Tennessee, 38119, United States

Location

Nashville Vision Associates

Nashville, Tennessee, 37205, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Limitations and Caveats

Intranasal and Extranasal data for this crossover study are combined because there is only access to combined arm data for this study. The study was acquired from another organization and limited results data are available.

Results Point of Contact

• Title: Therapeutic Area, Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Michelle Senchyna

  Allergan

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: September 22, 2016
• Study Start: September 30, 2016
• Primary Completion: October 31, 2016
• Study Completion: October 31, 2016
• Last Updated: January 31, 2020
• Results First Posted: January 31, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)