Evaluation of the Safety and Effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator in Patients With Dry Eye
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 22 - Any |
| Updated: | 6/3/2016 |
| Start Date: | December 2014 |
| End Date: | April 2015 |
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
The purpose of this study is to assess the safety and effectiveness of the Oculeve
Intranasal Lacrimal Neurostimulator for the treatment of dry eye disease.
Intranasal Lacrimal Neurostimulator for the treatment of dry eye disease.
In this study, the safety and effectiveness of the Intranasal Lacrimal Neurostimulator
applied intranasally compared with the same device applied extranasally to treat the
symptoms of dry eye exacerbated by the Controlled Adverse Environment (CAE) Model will be
evaluated.
applied intranasally compared with the same device applied extranasally to treat the
symptoms of dry eye exacerbated by the Controlled Adverse Environment (CAE) Model will be
evaluated.
Inclusion Criteria:
- Bilateral dry eyes
- Capable of providing written informed consent
Exclusion Criteria:
- Chronic or recurring epistaxis (nosebleeds)
- Uncontrolled systemic disease
- Blood coagulation disorder
- Females who are pregnant, nursing or planning a pregnancy
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