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Completed

NCT Number: NCT02798289

Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator

The primary objective of this study is to evaluate acute tear production as measured by tear meniscus height (TMH) captured by optical coherence tomography (OCT) after single use of the Oculeve Intranasal Neurostimulator (OIN) in participants with dry eye.

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Key information

Conditions

Dry Eye Syndrome Conjunctival Diseases Conjunctivitis Corneal Diseases Dry Eye Syndromes Eye Diseases Keratitis Keratoconjunctivitis Keratoconjunctivitis Sicca Lacrimal Apparatus Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sall Research Medical Center, Artesia, California, United States

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About this study

This is a prospective, single-arm, multicenter, open-label clinical trial in which participants will use the OIN once following study enrollment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with dry eye disease
  • Literate, able to speak English or Spanish, and able to complete questionnaires independently
  • Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol

Exclusion criteria

  • Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to clinically significant increased bleeding
  • Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma
  • Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device
  • Corneal transplant in either or both eyes
  • Participation in any clinical trial with a new active substance or a new device within 30 days of the Screening Visit
  • Women who are pregnant, planning a pregnancy, or nursing at the Screening Visit

Treatment and study plan

Oculeve Intranasal Neurostimulator

Device

Neurostimulation device

Primary outcomes

  1. Tear Meniscus Height Captured by Optical Coherence Tomography

    Time frame: Day 1

    Tear meniscus Height was measured before and after stimulation with Oculeve Intranasal Neurostimulator using Optical Coherence Tomography.

Sponsors and collaborators

Lead sponsor

Oculeve, Inc.

Industry

Registry information

Official study title

A Single Arm, Multicenter, Open-Label Study Designed to Evaluate Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 14, 2016
Registry last updated
Oct 25, 2017

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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