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

Dry Eye Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02680158
• Other study ID #: OCUN-009
• Status: Completed
• Phase: N/A
• Start date: January 31, 2016
• Est. completion date: March 31, 2016

Study information

• Verified date: April 2019
• Source: Oculeve, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a prospective, randomized, controlled, double-masked, multicenter clinical trial in which participants with aqueous tear deficiency will receive three different device applications in a randomized sequence.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 31, 2016
• Est. primary completion date: March 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Participants with aqueous tear deficiency

• Literate, able to speak English or Spanish, and able to complete questionnaires independently

• Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol

Exclusion Criteria:

• Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to clinically significant increased bleeding

• Nasal or sinus surgery including nasal cautery or significant trauma

• Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device

• Diagnosis of epilepsy

• Corneal transplant in either or both eyes

• Participation in any clinical trial with a new active substance or a new device within 30 days of the Screening Visit

• A woman who is pregnant, planning a pregnancy, or nursing at the Screening Visit

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Device:
• Oculeve Intranasal
Oculeve device, intranasal (test) application for approximately 3 minutes.
• Sham
Sham device (control), intranasal application for approximately 3 minutes.
• Oculeve Extranasal
Oculeve device, extranasal (control) application for approximately 3 minutes.

Locations

Country	Name	City	State
United States	Virginia Eye Consultants	Norfolk	Virginia
United States	The Eye Care Group	Waterbury	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Oculeve, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Corrected Distance Visual Acuity		1-Day
Other	Slit Lamp Biomicroscopy		1-Day
Other	Pulse Rate		1-Day
Other	Oxygen Saturation		1-Day
Other	Blood Pressure		1-Day
Primary	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
Primary	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