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

Not Applicable

Completed

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.

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Active - Device	Intranasal Lacrimal Neurostimulator (Oculeve)	The Oculeve Intranasal Lacrimal Neurostimulator will be administered two to ten times per day for up to three minutes per administration.

Primary Outcome Measures

Name	Time	Method
Stimulated Acute Tear Production	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

Name	Time	Method
Corrected Distance Visual Acuity	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).
Slit Lamp Biomicroscopy	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.

Locations (3): Andover Eye Associates
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Andover, Massachusetts, United States
Total Eye Care
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Memphis, Tennessee, United States
Cornea & Cataract Consultants of Arizona
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Phoenix, Arizona, United States