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Six Month Study to Evaluate the Safety and Effectiveness of the Intranasal Lacrimal Neurostimulator

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ClinicalTrials.gov Identifier: NCT02526290
Recruitment Status : Completed
First Posted : August 18, 2015
Results First Posted : October 31, 2017
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
Oculeve, Inc.

Brief Summary:
In this study, the safety and effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator after 180 days of use in participants with aqueous tear deficiency will be evaluated.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Keratoconjunctivitis Sicca Device: Intranasal Lacrimal Neurostimulator (Oculeve) Not Applicable

Detailed Description:
This is a prospective, single-arm, multicenter, open-label clinical trial in which participants will use the Oculeve Intranasal Lacrimal Neurostimulator to stimulate tear production for 180 days. Participants will have a Screening Visit within 60 days prior to the initial device application. Device application will be initiated at Day 0, at which time participants will receive training on the proper use of the device. Participants will receive follow-up visits at Days 7, 30, 90 and 180.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Single-Arm, Multicenter, Open-Label Study to Evaluate the Safety and Effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator in Participants With Aqueous Tear Deficient Dry Eye
Actual Study Start Date : August 31, 2015
Actual Primary Completion Date : April 30, 2016
Actual Study Completion Date : April 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Experimental: Active - Device
The Oculeve Intranasal Lacrimal Neurostimulator will be administered two to ten times per day for up to three minutes per administration.
Device: Intranasal Lacrimal Neurostimulator (Oculeve)
Neurostimulation device




Primary Outcome Measures :
  1. Stimulated Acute Tear Production [ Time Frame: The stimulated and prestimulation (basal) measures were both performed at Day 180. ]
    Stimulated acute tear production in the study eye at Day 180 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.


Secondary Outcome Measures :
  1. Corrected Distance Visual Acuity [ Time Frame: Baseline and 6 months ]
    Change from baseline (Day 0) in corrected distance visual acuity at Day 180. Corrected visual acuity was obtained using the subject's own glasses (for subjects that wear glasses) and measured in logMAR (log of the Minimum Angle of Resolution) units using an appropriate eye chart. A logMAR score of 0.0 is equivalent to a visual acuity of 20/20 and larger logMAR values indicate a poorer visual acuity (eg. A value of 0.3 corresponds to a visual acuity of 20/40).

  2. Slit Lamp Biomicroscopy [ Time Frame: 6 months ]
    Number of subjects with clinically significant (CS) findings noted from the slit lamp biomicroscopy examinations. A slit lamp biomicroscopy examination of the eyelids, cornea, conjunctiva, anterior chamber, and lens was performed at each visit for each eye. The results were graded as normal, abnormal not clinically significant (NCS), or abnormal CS. In addition, the cornea was scored specifically for corneal edema using a 4-point scale (0=None, +1=Mild, +2=Moderate and +3=Severe). An increase in corneal edema grade of two or more was considered clinically significant and evaluated as a potential AE by the investigator.


Other Outcome Measures:
  1. Device-related Adverse Events [ Time Frame: 6 months ]
    Number of subjects who experienced any device-related adverse events.



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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:

  • Subjects with moderate to severe 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
  • 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
  • Women who are 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): NCT02526290


Locations
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United States, Arizona
Cornea & Cataract Consultants of Arizona
Phoenix, Arizona, United States, 85032
United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
United States, Tennessee
Total Eye Care
Memphis, Tennessee, United States, 38119
Sponsors and Collaborators
Oculeve, Inc.
Investigators
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Study Director: Edward Holland, MD Cincinnati Eye Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Oculeve, Inc.
ClinicalTrials.gov Identifier: NCT02526290     History of Changes
Other Study ID Numbers: OCUN-010
First Posted: August 18, 2015    Key Record Dates
Results First Posted: October 31, 2017
Last Update Posted: October 31, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases