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NCT02313454 · ClinicalTrials.gov registry record · NA
Evaluation of the Safety and Effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator in Patients With Dry Eye
A NA study, sponsored by Allergan.
- Completed
- Registry status
- NA
- Development phase
- 21
- Enrollment target
NCT02313454: Completed NA study, sponsored by Allergan.
NCT02313454 is a NA study that has completed, run by Allergan. The registered enrollment target is 21 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02313454, a NA study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the safety and effectiveness of the Intranasal Tear Neurostimulator applied intranasally compared with the same device applied extranasally (control) in treating the symptoms of dry eye exacerbated by the Controlled Adverse Environment (CAE) Model.
Primary Outcome
The participant graded their eye discomfort prior to CAE entry, during CAE exposure to threshold, then starting 1 minute after treatment application every 5 minutes in each eye separately using the Ora Calibra ODS where: 0=no discomfort to 4=constant discomfort. Data from the analysis eye was used to determine effectiveness. The analysis eye was defined as the first eye that reached the threshold and resulted in the device application. If both eyes reached the threshold at the same time point, t
Interventions
- DEVICE Intranasal Tear Neurostimulator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2014-11-17 |
| Est. Completion | 2015-04-08 |
| Phase | NA |
What the finished NCT02313454 record still lists
NCT02313454 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Intranasal Tear Neurostimulator is the first listed.
NCT02313454 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02313454 about?
NCT02313454 is a clinical study titled "Evaluation of the Safety and Effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator in Patients With Dry Eye". The purpose of this study was to evaluate the safety and effectiveness of the Intranasal Tear Neurostimulator applied intranasally compared with the same device applied extranasally (control) in treating the symptoms of dry eye exacerbated by the Controlled Adverse Environment (CAE) Model.
What is the current status of trial NCT02313454?
This trial is currently completed. It is a NA study. The enrollment target is 21 participants. The study started on 2014-11-17. Estimated completion is 2015-04-08.
What interventions are being tested in trial NCT02313454?
The interventions under investigation include: Intranasal Tear Neurostimulator (DEVICE).
Who is sponsoring clinical trial NCT02313454?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02313454's enrollment target sits among peer trials
21 1762nd of 2000 higher than 233 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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