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

Dry Eye Syndromes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02526290
• Other study ID #: OCUN-010
• Status: Completed
• Phase: N/A
• First received: August 14, 2015
• Last updated: September 27, 2017
• Start date: August 31, 2015
• Est. completion date: April 30, 2016

Study information

• Verified date: September 2017
• Source: Oculeve, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: April 30, 2016
• Est. primary completion date: April 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca

Intervention

Device:
• Intranasal Lacrimal Neurostimulator (Oculeve)
Neurostimulation device

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts
United States	Total Eye Care	Memphis	Tennessee
United States	Cornea & Cataract Consultants of Arizona	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Oculeve, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Device-related Adverse Events	Number of subjects who experienced any device-related adverse events.	6 months
Primary	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.	The stimulated and prestimulation (basal) measures were both performed at Day 180.
Secondary	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).	Baseline and 6 months
Secondary	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.	6 months