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

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Allergan

Status

Completed

Conditions

Dry Eye Syndromes

Treatments

Device: Intranasal Tear Neurostimulator

Study type

Interventional

Funder types

Industry

Identifiers

NCT02313454
OCUN-007

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

21 participants in 2 patient groups

Intranasal Application
Experimental group
Description:
Intranasal Tear Neurostimulator device, intranasal application for approximately 3 minutes on Day 0 when the participant experienced an Ocular Discomfort Score (ODS) ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure.
Treatment:
Device: Intranasal Tear Neurostimulator
Extranasal Application
Sham Comparator group
Description:
Intranasal Tear Neurostimulator device, extranasal application for approximately 3 minutes on Day 0 when the participant experienced an ODS ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure.
Treatment:
Device: Intranasal Tear Neurostimulator

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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