N/A
Completed N=20
Evaluation of the Safety and Effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator in Patients With Dry Eye
Dry Eye Syndromes
Source: ClinicalTrials.gov NCT02313454 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcomePrimary: Change From Pre-Application to Post-Application in the Ora Calibra Ocular Discomfort Scale (ODS) Score — -1.1; -0.4 score on a scale — p=0.008
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Pre-Application to Post-Application in the Ora Calibra Ocular Discomfort Scale (ODS) Score |
-1.1; -0.4 | 0.008 sig |
| SECONDARY Change From Pre-Application to Post-Application in Dry Eye Symptoms (DES) Using a Visual Analog Scale (VAS) |
-18.7; -7.1 | 0.004 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02313454). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.