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NCT02680158 · ClinicalTrials.gov registry record · NA
A Study to Evaluate the Safety and Effectiveness of Oculeve Intranasal Lacrimal Neurostimulator in Participants With Dry Eye Syndrome
A NA study, sponsored by Oculeve.
- Completed
- Registry status
- NA
- Development phase
- 48
- Enrollment target
NCT02680158: Completed NA study, sponsored by Oculeve.
NCT02680158 is a NA study that has completed, run by Oculeve. The registered enrollment target is 48 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02680158, a NA study, has completed, sponsored by Oculeve.
- COMPLETED
- Registry status
- NA
- Development phase
- 48 participants
- Enrollment target
Study Summary
The purpose of this study is to compare acute tear production produced by the Oculeve Intranasal Lacrimal Neurostimulator with two control devices in participants with aqueous tear deficiency.
Primary Outcome
Stimulated acute tear production in the study eye at Day 0 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. The study eye was defined as the eye with the greatest increase in tear production with stimulation by the cotton swab at Visit 1/Screening or, if there was no difference in stimul
Interventions
- DEVICE Sham
- DEVICE Oculeve Intranasal
- DEVICE Oculeve Extranasal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2016-01-31 |
| Est. Completion | 2016-03-31 |
| Phase | NA |
What the finished NCT02680158 record still lists
NCT02680158 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which Sham is the first listed.
NCT02680158 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02680158 about?
NCT02680158 is a clinical study titled "A Study to Evaluate the Safety and Effectiveness of Oculeve Intranasal Lacrimal Neurostimulator in Participants With Dry Eye Syndrome". The purpose of this study is to compare acute tear production produced by the Oculeve Intranasal Lacrimal Neurostimulator with two control devices in participants with aqueous tear deficiency.
What is the current status of trial NCT02680158?
This trial is currently completed. It is a NA study. The enrollment target is 48 participants. The study started on 2016-01-31. Estimated completion is 2016-03-31.
What interventions are being tested in trial NCT02680158?
The interventions under investigation include: Sham (DEVICE), Oculeve Intranasal (DEVICE), Oculeve Extranasal (DEVICE).
Who is sponsoring clinical trial NCT02680158?
This trial is sponsored by Oculeve, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02680158's enrollment target sits among peer trials
48 1381st of 2000 higher than 601 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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