A Non-Randomized, Open-Label Study to Determine the Effect of Electrical Stimulation on Tear Production

Oculeve, Inc.1 site in 1 country4 target enrollmentJuly 2012

ConditionsDry Eye

Overview

Phase: N/A
Intervention: Not specified
Conditions: Dry Eye
Sponsor: Oculeve, Inc.
Enrollment: 4
Locations: 1
Primary Endpoint: Schirmer Score
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to investigate whether electrical stimulation of the nerve innervating the tear gland results in tear production in subjects with severe Dry Eye.

Detailed Description

A non-randomized, open-label study designed to investigate the feasibility of a novel treatment for severe Dry Eye Disease, which involves safe delivery of small electrical currents to the lacrimal nerve to induce tear production.

Registry

clinicaltrials.gov

Start Date

July 2012

End Date

July 2012

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Oculeve, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Schirmer test with topical anesthesia of ≤ 5 mm/5 min in at least one eye
•Sum of corneal and interpalpebral conjunctival staining of \> +5 in the same eye where corneal staining is \> +2 using the CLEK criteria.

Exclusion Criteria

•Individuals with the presence or history of any ocular disorder or condition (including ocular surgery, trauma, and disease) that could possibly interfere with the interpretation of the study results. Individuals who have had LASIK or other refractive surgeries are eligible. Excluded conditions include:
•History of orbital trauma
•History of orbital surgery
•Orbital cancer
•History of orbital cancer
•Within the 3 months before the Screening Visit, known history of ocular infection (viral, bacterial, fungal), inflammation not associated with dry eye, or active ocular herpes