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OpenTrials
Completed

NCT Number: NCT01630291

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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

APEC

La Concepción, Mexico City, 04030, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrode device

Device

Lacrimal gland stimulation

Other names: External Neurostimulator Trialing System (Medtronic)

Primary outcomes

  1. Schirmer Score

    Time frame: Up to 16 days

Sponsors and collaborators

Lead sponsor

Oculeve, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 28, 2012
Registry last updated
Dec 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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