N/A N=20 Randomized Single-blind Treatment

Evaluation of the Safety and Effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator in Patients With Dry Eye

Dry Eye Syndromes

Bottom Line

View on ClinicalTrials.gov: NCT02313454 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2020

Primary outcome: Primary: 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

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Intranasal Tear Neurostimulator (Device)
Age: Adult, Older Adult · 22+ yrs
Sex: All
Sponsor: Allergan
Primary completion: Apr 2015

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

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.

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

View full record on ClinicalTrials.gov →

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.