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The Effect of Electrical Stimulation on Tear Production

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ClinicalTrials.gov Identifier: NCT01630291
Recruitment Status : Completed
First Posted : June 28, 2012
Last Update Posted : December 10, 2014
Sponsor:
Information provided by (Responsible Party):
Oculeve, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dry Eye Device: Electrode device Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Non-Randomized, Open-Label Study to Determine the Effect of Electrical Stimulation on Tear Production
Study Start Date : July 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arms and Interventions
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Arm Intervention/treatment
Experimental: Electrical stimulation Device: Electrode device
Lacrimal gland stimulation
Other Name: External Neurostimulator Trialing System (Medtronic)


Outcome Measures
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Primary Outcome Measures :
  1. Schirmer Score [ Time Frame: Up to 16 days ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630291


Locations
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Mexico
APEC
La Concepcion, Distrito Federal, Mexico, 04030
Sponsors and Collaborators
Oculeve, Inc.
Investigators
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Principal Investigator: Guillermo Salcedo, M.D. Asociación para Evitar la Ceguera en México
More Information
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Responsible Party: Oculeve, Inc.
ClinicalTrials.gov Identifier: NCT01630291    
Other Study ID Numbers: OCU-002
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: December 10, 2014
Last Verified: December 2014