NCT02680158|CompletedResultsFDA Device

A Study to Evaluate the Safety and Effectiveness of Oculeve Intranasal Lacrimal Neurostimulator in Participants With Dry Eye Syndrome

A Randomized, Controlled, Double-Masked, Multicenter Trial Designed to Evaluate Acute Tear Production With the Oculeve Intranasal Lacrimal Stimulator Compared to Two Control Applications in Patients With Aqueous Deficient Dry Eye

Oculeve, Inc.ClinicalTrials.gov

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1 other identifier

OCUN-009

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredFeb 2016

StartedJan 2016

CompletionMar 2016

Brief Summary

The purpose of this study is to compare acute tear production produced by the Oculeve Intranasal Lacrimal Neurostimulator with two control devices in participants with aqueous tear deficiency.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Jan 2016

Shorter than P25 for not_applicable

Geographic Reach

1 country

2 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2 months study duration

First Submitted

Initial submission to the registry

January 21, 2016

Completed

10 days until next milestone

Study Start

First participant enrolled

January 31, 2016

Completed

11 days until next milestone

First Posted

Study publicly available on registry

February 11, 2016

Completed

2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2016

Completed

3.1 years until next milestone

Results Posted

Study results publicly available

April 26, 2019

Completed

Last Updated

April 26, 2019

Status Verified

April 1, 2019

Enrollment Period

2 months

First QC Date

January 21, 2016

Results QC Date

April 4, 2019

Last Update Submit

April 4, 2019

Conditions

Dry Eye Syndrome Keratoconjunctivitis Sicca

Outcome Measures

Primary Outcomes (2)

Acute Stimulated Tear Production
Stimulated acute tear production in the study eye at Day 0 as measured by the difference between the Schirmer test score during stimulation and the test score before stimulation (basal). The Schirmer strip is placed just under the eyelid and wicks up the tears. It measures tear production on a linear scale of 0-35 mm. The study eye was defined as the eye with the greatest increase in tear production with stimulation by the cotton swab at Visit 1/Screening or, if there was no difference in stimulated tear production, the eye with the lower basal Schirmer score at Visit 2/Day 0 was selected. If there was no difference for either measure, the right eye was used as the study eye.
Day 0 post-application
Percentage of Participants Who Experienced One or More Device-related Adverse Event (AE)
An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in participants, users or other persons it does not necessarily have to have a causal relationship with the investigational medical device. Device-related AEs were presented as ocular and non-ocular.
Day 0

Other Outcomes (5)

Corrected Distance Visual Acuity
1-Day
Slit Lamp Biomicroscopy
1-Day
Pulse Rate
1-Day
+2 more other outcomes

Study Arms (6)

Sequence 1-Intranasal: Extranasal: Sham

EXPERIMENTAL

Oculeve device, intranasal (test) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by sham device, intranasal (control) application, for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.