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

Dry Eye Syndromes Clinical Trial

Official title:

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 (CAESM) With Treatment by the Oculeve Nasal Lacrimal TENS Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02313454
• Other study ID #: OCUN-007
• Status: Completed
• Phase: N/A
• Start date: November 17, 2014
• Est. completion date: April 8, 2015

Study information

• Verified date: January 2020
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 8, 2015
• Est. primary completion date: April 8, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Device:
• Intranasal Tear Neurostimulator
Neurostimulation applied intranasally and extranasally.

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Allergan	ORA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Pre-Application to Post-Application in the Ora Calibra Ocular Discomfort Scale (ODS) Score	The participant graded their eye discomfort prior to CAE entry, during CAE exposure to threshold, then starting 1 minute after treatment application every 5 minutes in each eye separately using the Ora Calibra ODS where: 0=no discomfort to 4=constant discomfort. Data from the analysis eye was used to determine effectiveness. The analysis eye was defined as the first eye that reached the threshold and resulted in the device application. If both eyes reached the threshold at the same time point, the analysis eye was the eye with the lowest baseline Schirmer test score (a test to determine if the eye produces enough tears to keep it moist; >10 mm is normal) or, if the Schirmer test scores were equal, the right eye. A negative change from Baseline indicates improvement.	Pre-application to Post-application on Day 0
Secondary	Change From Pre-Application to Post-Application in Dry Eye Symptoms (DES) Using a Visual Analog Scale (VAS)	The participant rated their eye dryness (both eyes simultaneously) at all visits and every 5 minutes during CAE exposure by placing a vertical mark on the 100 mm horizontal line to indicate the level of eye dryness. 0 corresponds to "no dryness" and 100 corresponds to "maximal dryness". A negative change from Baseline indicates improvement.	Pre-application to Post-application on Day 0