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History of Changes for Study: NCT02526290
Six Month Study to Evaluate the Safety and Effectiveness of the Intranasal Lacrimal Neurostimulator
Latest version (submitted September 27, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 17, 2015 None (earliest Version on record)
2 September 2, 2015 Contacts/Locations, Arms and Interventions and Study Status
3 November 11, 2015 Recruitment Status, Study Status, Contacts/Locations and Study Design
4 January 25, 2016 Study Status and IPDSharing
5 June 1, 2016 Recruitment Status, Study Status
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Results Submission Events
6 September 27, 2017 Study Status, Outcome Measures, Results and IPDSharing
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Study NCT02526290
Submitted Date:  August 17, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: OCUN-010
Brief Title: Six Month Study to Evaluate the Safety and Effectiveness of the Intranasal Lacrimal Neurostimulator
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
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2015
Overall Status: Recruiting
Study Start: August 2015
Primary Completion: May 2016 [Anticipated]
Study Completion: May 2016 [Anticipated]
First Submitted: August 14, 2015
First Submitted that
Met QC Criteria:
August 17, 2015
First Posted: August 18, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 17, 2015
Last Update Posted: August 18, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Oculeve, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Dry Eye Syndromes
Keratoconjunctivitis Sicca
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Supportive Care
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 100 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Active
Oculeve Intranasal Lacrimal Neurostimulator
Device: Intranasal Lacrimal Neurostimulator (Oculeve)
Neurostimulation device
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Stimulated acute tear production
[ Time Frame: 6 months ]

Secondary Outcome Measures:
1. Corrected distance visual acuity
[ Time Frame: 6 months ]

2. Slit lamp biomicroscopy
[ Time Frame: 6 months ]

Other Outcome Measures:
1. Device-related adverse events
[ Time Frame: 6 months ]

Open or close this module Eligibility
Minimum Age: 22 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Stephanie Baba
Email: stephanie@oculeve.com
Central Contact Backup: Mark Holdbrook
Email: mark@oculeve.com
Study Officials: Edward Holland, MD
Study Director
Cincinnati Eye Institute
Locations: United States, Massachusetts
Andover Eye Associates
[Recruiting]
Andover, Massachusetts, United States, 01810
Contact:Contact: Blaine Brown bbrown@oraclinical.com
Contact:Principal Investigator: Gail Torkildsen, MD
United States, Tennessee
Total Eye Care
[Recruiting]
Memphis, Tennessee, United States, 38119
Contact:Contact: Daniel Ashe dashe6060tec@gmail.com
Contact:Principal Investigator: Eugene McLaurin, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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