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

Oculeve, Inc.97 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Dry Eye Syndromes Keratoconjunctivitis Sicca

Interventions

Intranasal Lacrimal Neurostimulator (Oculeve)DEVICE

Neurostimulation device

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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

Locations (3)

Cornea & Cataract Consultants of Arizona

Phoenix, Arizona, United States

Andover Eye Associates

Andover, Massachusetts, United States

Total Eye Care

Memphis, Tennessee, United States

Outcomes

Primary Outcomes

Stimulated Acute Tear Production

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.

Time frame: The stimulated and prestimulation (basal) measures were both performed at Day 180.

Secondary Outcomes

Corrected Distance Visual Acuity

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).

Time frame: Baseline and 6 months

Slit Lamp Biomicroscopy

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.

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.