Six Month Study to Evaluate the Safety and Effectiveness of the Intranasal Lacrimal Neurostimulator

• ClinicalTrials.gov Identifier: NCT02526290
• Recruitment Status: Completed
• First Posted: August 18, 2015
• Results First Posted: October 31, 2017
• Last Update Posted: October 31, 2017
• Sponsor: Oculeve, Inc.
• Information provided by (Responsible Party): Oculeve, Inc.

Study Description

Brief Summary:

In this study, the safety and effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator after 180 days of use in participants with aqueous tear deficiency will be evaluated.

Condition or disease	Intervention/treatment	Phase
Dry Eye Syndromes; Keratoconjunctivitis Sicca	Device: Intranasal Lacrimal Neurostimulator (Oculeve)	Not Applicable

Detailed Description:

This is a prospective, single-arm, multicenter, open-label clinical trial in which participants will use the Oculeve Intranasal Lacrimal Neurostimulator to stimulate tear production for 180 days. Participants will have a Screening Visit within 60 days prior to the initial device application. Device application will be initiated at Day 0, at which time participants will receive training on the proper use of the device. Participants will receive follow-up visits at Days 7, 30, 90 and 180.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 97 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Single-Arm, Multicenter, Open-Label Study to Evaluate the Safety and Effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator in Participants With Aqueous Tear Deficient Dry Eye
• Actual Study Start Date: August 31, 2015
• Actual Primary Completion Date: April 30, 2016
• Actual Study Completion Date: April 30, 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Active - Device; The Oculeve Intranasal Lacrimal Neurostimulator will be administered two to ten times per day for up to three minutes per administration.	Device: Intranasal Lacrimal Neurostimulator (Oculeve); Neurostimulation device

Outcome Measures

Primary Outcome Measures :

1. Stimulated Acute Tear Production [ Time Frame: The stimulated and prestimulation (basal) measures were both performed at Day 180. ]
   Stimulated acute tear production in the study eye at Day 180 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.

Secondary Outcome Measures :

1. Corrected Distance Visual Acuity [ Time Frame: Baseline and 6 months ]
   Change from baseline (Day 0) in corrected distance visual acuity at Day 180. Corrected visual acuity was obtained using the subject's own glasses (for subjects that wear glasses) and measured in logMAR (log of the Minimum Angle of Resolution) units using an appropriate eye chart. A logMAR score of 0.0 is equivalent to a visual acuity of 20/20 and larger logMAR values indicate a poorer visual acuity (eg. A value of 0.3 corresponds to a visual acuity of 20/40).
2. Slit Lamp Biomicroscopy [ Time Frame: 6 months ]
   Number of subjects with clinically significant (CS) findings noted from the slit lamp biomicroscopy examinations. A slit lamp biomicroscopy examination of the eyelids, cornea, conjunctiva, anterior chamber, and lens was performed at each visit for each eye. The results were graded as normal, abnormal not clinically significant (NCS), or abnormal CS. In addition, the cornea was scored specifically for corneal edema using a 4-point scale (0=None, +1=Mild, +2=Moderate and +3=Severe). An increase in corneal edema grade of two or more was considered clinically significant and evaluated as a potential AE by the investigator.

Other Outcome Measures:

1. Device-related Adverse Events [ Time Frame: 6 months ]
   Number of subjects who experienced any device-related adverse events.

Eligibility Criteria

• Ages Eligible for Study: 22 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Subjects with moderate to severe dry eye disease
• 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 history of application of 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
• Women who are pregnant, planning a pregnancy, or nursing at the Screening Visit

Contacts and Locations

Locations

United States, Arizona

Cornea & Cataract Consultants of Arizona

Phoenix, Arizona, United States, 85032

United States, Massachusetts

Andover Eye Associates

Andover, Massachusetts, United States, 01810

United States, Tennessee

Total Eye Care

Memphis, Tennessee, United States, 38119

Sponsors and Collaborators

Oculeve, Inc.

Investigators

• Study Director: Edward Holland, MD; Cincinnati Eye Institute

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sheppard JD, Torkildsen GL, Geffin JA, Dao J, Evans DG, Ousler GW, Wilson J, Baba SN, Senchyna M, Holland EJ. Characterization of tear production in subjects with dry eye disease during intranasal tear neurostimulation: Results from two pivotal clinical trials. Ocul Surf. 2019 Jan;17(1):142-150. doi: 10.1016/j.jtos.2018.11.009. Epub 2018 Nov 22.

• Responsible Party: Oculeve, Inc.
• ClinicalTrials.gov Identifier: NCT02526290 History of Changes
• Other Study ID Numbers: OCUN-010
• First Posted: August 18, 2015
• Results First Posted: October 31, 2017
• Last Update Posted: October 31, 2017
• Last Verified: September 2017

Additional relevant MeSH terms:

Keratoconjunctivitis Sicca; Dry Eye Syndromes; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Eye Diseases; Keratitis; Corneal Diseases; Lacrimal Apparatus Diseases