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

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ClinicalTrials.gov Identifier: NCT02680158
Recruitment Status : Completed
First Posted : February 11, 2016
Results First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Oculeve, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndrome Keratoconjunctivitis Sicca Device: Oculeve Intranasal Device: Sham Device: Oculeve Extranasal Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Three way cross-over study with 6 sequences.
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official 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
Actual Study Start Date : January 31, 2016
Actual Primary Completion Date : March 31, 2016
Actual Study Completion Date : March 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Experimental: Sequence 1-Intranasal: Extranasal: Sham
Oculeve device, intranasal (test) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by sham device, intranasal (control) application, for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.
Device: Oculeve Intranasal
Oculeve device, intranasal (test) application for approximately 3 minutes.

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

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

Experimental: Sequence 2-Intranasal: Sham: Extranasal
Oculeve device, intranasal (test) application for approximately 3 minutes followed by sham device, intranasal (control) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.
Device: Oculeve Intranasal
Oculeve device, intranasal (test) application for approximately 3 minutes.

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

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

Experimental: Sequence 3-Extranasal: Intranasal: Sham
Oculeve device, extranasal (control) application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes, followed by sham device (control), intranasal application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.
Device: Oculeve Intranasal
Oculeve device, intranasal (test) application for approximately 3 minutes.

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

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

Experimental: Sequence 4-Extranasal: Sham: Intranasal
Oculeve device, extranasal (control) application for approximately 3 minutes followed by sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.
Device: Oculeve Intranasal
Oculeve device, intranasal (test) application for approximately 3 minutes.

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

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

Experimental: Sequence 5-Sham: Intranasal: Extranasal
Sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by on Day 0. There was rest period of 60 minutes before proceeding to the next application.
Device: Oculeve Intranasal
Oculeve device, intranasal (test) application for approximately 3 minutes.

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

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

Experimental: Sequence 6-Sham: Extranasal: Intranasal
Sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes followed by on Day 0. There was rest period of 60 minutes before proceeding to the next application.
Device: Oculeve Intranasal
Oculeve device, intranasal (test) application for approximately 3 minutes.

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

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




Primary Outcome Measures :
  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 Outcome Measures:
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02680158


Locations
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United States, Connecticut
The Eye Care Group
Waterbury, Connecticut, United States, 06708
United States, Virginia
Virginia Eye Consultants
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Oculeve, Inc.
Investigators
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Study Director: Michelle Senchyna Allergan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Oculeve, Inc.
ClinicalTrials.gov Identifier: NCT02680158     History of Changes
Other Study ID Numbers: OCUN-009
First Posted: February 11, 2016    Key Record Dates
Results First Posted: April 26, 2019
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
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Syndrome
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Disease
Pathologic Processes
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases