Trials / Completed
CompletedNCT02313454
Evaluation of the Safety and Effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator in Patients With Dry Eye
A Single Center, Randomized, Controlled, Single-Masked, Cross-Over Clinical Pilot Study to Evaluate the Reduction in the Exacerbation of the Symptoms of Dry Eye Upon Exposure to a Controlled Adverse Environment (CAESM) With Treatment by the Oculeve Nasal Lacrimal TENS Unit
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Allergan · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Intranasal Tear Neurostimulator | Neurostimulation applied intranasally and extranasally. |
Timeline
- Start date
- 2014-11-17
- Primary completion
- 2015-04-08
- Completion
- 2015-04-08
- First posted
- 2014-12-10
- Last updated
- 2020-01-31
- Results posted
- 2020-01-31
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02313454. Inclusion in this directory is not an endorsement.