Back to resultsThe Effect of Electrical Stimulation on Tear Production
Primary Purpose
Dry Eye
Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Electrode device
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
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
Sites / Locations
- APEC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Electrical stimulation
Arm Description
Outcomes
Primary Outcome Measures
Schirmer Score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01630291
Brief Title
The Effect of Electrical Stimulation on Tear Production
Official Title
A Non-Randomized, Open-Label Study to Determine the Effect of Electrical Stimulation on Tear Production
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oculeve, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electrical stimulation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Electrode device
Other Intervention Name(s)
External Neurostimulator Trialing System (Medtronic)
Intervention Description
Lacrimal gland stimulation
Primary Outcome Measure Information:
Title
Schirmer Score
Time Frame
Up to 16 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillermo Salcedo, M.D.
Organizational Affiliation
Asociación para Evitar la Ceguera en México
Official's Role
Principal Investigator
Facility Information:
Facility Name
APEC
City
La Concepcion
State/Province
Distrito Federal
ZIP/Postal Code
04030
Country
Mexico
12. IPD Sharing Statement
Learn more about this trial
The Effect of Electrical Stimulation on Tear Production
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