NCT01630291CompletedNot Applicable
A Non-Randomized, Open-Label Study to Determine the Effect of Electrical Stimulation on Tear Production
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Oculeve, Inc.
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Schirmer Score
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Electrical stimulation
Experimental
Intervention: Electrode device (Device)
Outcomes
Primary Outcomes
Schirmer Score
Time Frame: Up to 16 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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