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Completed

NCT Number: NCT02910713

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

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.

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye Care Institute, Louisville, Kentucky, United States

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About this study

Participants will be randomized to a single application sequence, either sequence "A" (intranasal application followed by control application) or sequence "B" (control application followed by intranasal application) using the device. Upon entering the CAE, participants will complete dry eye questionnaires every five minutes and will administer the device either intranasally or extranasally in randomized sequence when a certain level of ocular discomfort has been reached.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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
  • 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

Treatment and study plan

Intranasal Tear Neurostimulator

Device

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

Primary outcomes

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

    Time frame: Pre-application to Post-application on Day 0

    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.

Secondary outcomes

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

    Time frame: Pre-application to Post-application on Day 0

    The participant graded their eye discomfort prior to CAE entry, during CAE exposure to threshold, then starting 1 minute after treatment application every 5 minutes in each eye separately using the Ora Calibra ODS where: 0=no discomfort to 4=constant discomfort. Data from the analysis eye was used to determine effectiveness. The analysis eye was defined as the eye that reached the threshold triggering the first application or if both eyes reach the threshold at the same time, the eye with the higher discomfort score or if both eyes are the same, the right eye was used. 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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

Multicenter, Randomized, Controlled, Single-Masked, Cross-Over Clinical Trial to Evaluate Dry Eye Symptoms With Application of the Oculeve Intranasal Tear Neurostimulator During Exposure to a Controlled Adverse Environment (CAE®)

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 22, 2016
Registry last updated
Jan 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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