The Effect of Electrical Stimulation on Tear Production

A Non-Randomized, Open-Label Study to Determine the Effect of Electrical Stimulation on Tear Production

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Device: Electrode device

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Distrito Federal
    • La Concepcion, Distrito Federal, Mexico, 04030
      • APEC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electrical stimulation	Device: Electrode device; Lacrimal gland stimulation; Other Names: External Neurostimulator Trialing System (Medtronic)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Schirmer Score	Up to 16 days

Collaborators and Investigators

• Sponsor: Oculeve, Inc.
• Investigators: Principal Investigator: Guillermo Salcedo, M.D., Asociación Para Evitar la Ceguera en México

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: June 15, 2012
• First Submitted That Met QC Criteria: June 26, 2012
• First Posted (Estimate): June 28, 2012

Study Record Updates

• Last Update Posted (Estimate): December 10, 2014
• Last Update Submitted That Met QC Criteria: December 8, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: OCU-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No