The Effect of Electrical Stimulation on Tear Production

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oculeve, Inc.
ClinicalTrials.gov Identifier:
NCT01630291
First received: June 15, 2012
Last updated: December 8, 2014
Last verified: December 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Oculeve, Inc.
ClinicalTrials.gov Identifier: NCT01630291     History of Changes
Other Study ID Numbers: OCU-002
Study First Received: June 15, 2012
Last Updated: December 8, 2014
Health Authority: Mexico: Ethics Committee

ClinicalTrials.gov processed this record on September 03, 2015