Six Month Study to Evaluate the Safety and Effectiveness of the Intranasal Lacrimal Neurostimulator
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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
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Sponsor:
Oculeve, Inc.
Information provided by (Responsible Party):
Oculeve, Inc.
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care |
Conditions |
Dry Eye Syndromes Keratoconjunctivitis Sicca |
Intervention |
Device: Intranasal Lacrimal Neurostimulator (Oculeve) |
Enrollment | 97 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Active - Device |
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The Oculeve Intranasal Lacrimal Neurostimulator will be administered two to ten times per day for up to three minutes per administration. Intranasal Lacrimal Neurostimulator (Oculeve): Neurostimulation device |
Period Title: Overall Study | |
Started | 97 |
Completed | 89 |
Not Completed | 8 |
Reason Not Completed | |
Adverse Event | 3 |
Withdrawal by Subject | 4 |
Physician Decision | 1 |
Baseline Characteristics
Arm/Group Title | Active - Device | |
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The Oculeve Intranasal Lacrimal Neurostimulator will be administered two to ten times per day for up to three minutes per administration. Intranasal Lacrimal Neurostimulator (Oculeve): Neurostimulation device | |
Overall Number of Baseline Participants | 97 | |
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[Not Specified]
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Age, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 97 participants |
< 50 years | 15 | |
50 to <60 years | 25 | |
60 to <70 years | 40 | |
≥70 years | 17 | |
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 97 participants | |
Female |
77 79.4%
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Male |
20 20.6%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title: | Therapeutic Area Head |
Organization: | Allergan, Inc. |
Phone: | 714-246-4500 |
EMail: | clinicaltrials@allergan.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Oculeve, Inc. |
ClinicalTrials.gov Identifier: | NCT02526290 |
Other Study ID Numbers: |
OCUN-010 |
First Submitted: | August 14, 2015 |
First Posted: | August 18, 2015 |
Results First Submitted: | July 13, 2017 |
Results First Posted: | October 31, 2017 |
Last Update Posted: | October 31, 2017 |