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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE August 14, 2015
First Posted Date  ICMJE August 18, 2015
Results First Submitted Date  ICMJE July 13, 2017
Results First Posted Date  ICMJE October 31, 2017
Last Update Posted Date October 31, 2017
Actual Study Start Date  ICMJE August 31, 2015
Actual Primary Completion Date April 30, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 17, 2015)
Stimulated Acute Tear Production [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2017)
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2015)
  • Corrected Distance Visual Acuity [ Time Frame: 6 months ]
  • Slit Lamp Biomicroscopy [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures
 (submitted: September 27, 2017)
Device-related Adverse Events [ Time Frame: 6 months ]
Number of subjects who experienced any device-related adverse events.
Original Other Pre-specified Outcome Measures
 (submitted: August 17, 2015)
Device-related Adverse Events [ Time Frame: 6 months ]
 
Descriptive Information
Brief Title  ICMJE Six Month Study to Evaluate the Safety and Effectiveness of the Intranasal Lacrimal Neurostimulator
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Dry Eye Syndromes
  • Keratoconjunctivitis Sicca
Intervention  ICMJE Device: Intranasal Lacrimal Neurostimulator (Oculeve)
Neurostimulation device
Study Arms  ICMJE Experimental: Active - Device
The Oculeve Intranasal Lacrimal Neurostimulator will be administered two to ten times per day for up to three minutes per administration.
Intervention: Device: Intranasal Lacrimal Neurostimulator (Oculeve)
Publications * Sheppard JD, Torkildsen GL, Geffin JA, Dao J, Evans DG, Ousler GW, Wilson J, Baba SN, Senchyna M, Holland EJ. Characterization of tear production in subjects with dry eye disease during intranasal tear neurostimulation: Results from two pivotal clinical trials. Ocul Surf. 2019 Jan;17(1):142-150. doi: 10.1016/j.jtos.2018.11.009. Epub 2018 Nov 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 11, 2015)
97
Original Estimated Enrollment  ICMJE
 (submitted: August 17, 2015)
100
Actual Study Completion Date  ICMJE April 30, 2016
Actual Primary Completion Date April 30, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02526290
Other Study ID Numbers  ICMJE OCUN-010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Oculeve, Inc.
Study Sponsor  ICMJE Oculeve, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Edward Holland, MD Cincinnati Eye Institute
PRS Account Oculeve, Inc.
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP