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The Effect of Electrical Stimulation on Tear Production

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01630291
First Posted: June 28, 2012
Last Update Posted: December 10, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Oculeve, Inc.
  Purpose
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 Intervention
Dry Eye Device: Electrode device

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Oculeve, Inc.:

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

Enrollment: 4
Study Start Date: July 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Electrical stimulation Device: Electrode device
Lacrimal gland stimulation
Other Name: External Neurostimulator Trialing System (Medtronic)

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
Mexico
APEC
La Concepcion, Distrito Federal, Mexico, 04030
Sponsors and Collaborators
Oculeve, Inc.
Investigators
Principal Investigator: Guillermo Salcedo, M.D. Asociación para Evitar la Ceguera en México
  More Information

Responsible Party: Oculeve, Inc.
ClinicalTrials.gov Identifier: NCT01630291     History of Changes
Other Study ID Numbers: OCU-002
First Submitted: June 15, 2012
First Posted: June 28, 2012
Last Update Posted: December 10, 2014
Last Verified: December 2014