Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator
A Single Arm, Multicenter, Open-Label Study Designed to Evaluate Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator
1 other identifier
interventional
55
1 country
2
Brief Summary
The primary objective of this study is to evaluate acute tear production as measured by tear meniscus height (TMH) captured by optical coherence tomography (OCT) after single use of the Oculeve Intranasal Neurostimulator (OIN) in participants with dry eye.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2016
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 9, 2016
CompletedFirst Posted
Study publicly available on registry
June 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
October 25, 2017
CompletedOctober 25, 2017
September 1, 2017
2 months
June 9, 2016
September 27, 2017
September 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Tear Meniscus Height Captured by Optical Coherence Tomography
Tear meniscus Height was measured before and after stimulation with Oculeve Intranasal Neurostimulator using Optical Coherence Tomography.
Day 1
Study Arms (1)
Active - Device
EXPERIMENTALThe Oculeve Intranasal Neurostimulator will be administered once to induce aqueous tear production once following study enrollment.
Interventions
Eligibility Criteria
You may qualify if:
- Subjects with 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oculeve, Inc.lead
Study Sites (2)
Sall Research Medical Center
Artesia, California, 90701, United States
Aesthetic Eyecare Institute
Newport Beach, California, 92663, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Allergan, Inc.
Study Officials
- STUDY DIRECTOR
Neil Friedman, MD
Mid-Peninsula Ophthalmology Medical Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2016
First Posted
June 14, 2016
Study Start
June 1, 2016
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
October 25, 2017
Results First Posted
October 25, 2017
Record last verified: 2017-09