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Completed

NCT Number: NCT02680158

A Study to Evaluate the Safety and Effectiveness of Oculeve Intranasal Lacrimal Neurostimulator in Participants With Dry Eye Syndrome

The purpose of this study is to compare acute tear production produced by the Oculeve Intranasal Lacrimal Neurostimulator with two control devices in participants with aqueous tear deficiency.

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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

The Eye Care Group, Waterbury, Connecticut, United States

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About this study

This is a prospective, randomized, controlled, double-masked, multicenter clinical trial in which participants with aqueous tear deficiency will receive three different device applications in a randomized sequence.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants with aqueous tear deficiency
  • 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 nasal cautery or significant trauma
  • Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device
  • Diagnosis of epilepsy
  • 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
  • A woman who is pregnant, planning a pregnancy, or nursing at the Screening Visit

Treatment and study plan

Oculeve Intranasal

Device

Oculeve device, intranasal (test) application for approximately 3 minutes.

SHAM

Device

Sham device (control), intranasal application for approximately 3 minutes.

Oculeve Extranasal

Device

Oculeve device, extranasal (control) application for approximately 3 minutes.

Primary outcomes

  1. Acute Stimulated Tear Production

    Time frame: Day 0 post-application

    Stimulated acute tear production in the study eye at Day 0 as measured by the difference between the Schirmer test score during stimulation and the test score before stimulation (basal). The Schirmer strip is placed just under the eyelid and wicks up the tears. It measures tear production on a linear scale of 0-35 mm. The study eye was defined as the eye with the greatest increase in tear production with stimulation by the cotton swab at Visit 1/Screening or, if there was no difference in stimulated tear production, the eye with the lower basal Schirmer score at Visit 2/Day 0 was selected. If there was no difference for either measure, the right eye was used as the study eye.

  2. Percentage of Participants Who Experienced One or More Device-related Adverse Event (AE)

    Time frame: Day 0

    An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in participants, users or other persons it does not necessarily have to have a causal relationship with the investigational medical device. Device-related AEs were presented as ocular and non-ocular.

Other outcomes

  1. Corrected Distance Visual Acuity

    Time frame: 1-Day

  2. Slit Lamp Biomicroscopy

    Time frame: 1-Day

  3. Pulse Rate

    Time frame: 1-Day

  4. Oxygen Saturation

    Time frame: 1-Day

  5. Blood Pressure

    Time frame: 1-Day

Sponsors and collaborators

Lead sponsor

Oculeve, Inc.

Industry

Registry information

Official study title

A Randomized, Controlled, Double-Masked, Multicenter Trial Designed to Evaluate Acute Tear Production With the Oculeve Intranasal Lacrimal Stimulator Compared to Two Control Applications in Patients With Aqueous Deficient Dry Eye

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 11, 2016
Registry last updated
Apr 26, 2019

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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