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The Effect of Electrical Stimulation on Tear Production

NCT ID: NCT01630291

Last Updated: 2014-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dry Eye

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Electrical stimulation

Group Type EXPERIMENTAL

Electrode device

Intervention Type DEVICE

Lacrimal gland stimulation

Interventions

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Electrode device

Lacrimal gland stimulation

Intervention Type DEVICE

Other Intervention Names

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External Neurostimulator Trialing System (Medtronic)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oculeve, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillermo Salcedo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Asociación para Evitar la Ceguera en México

Locations

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APEC

La Concepción, Mexico City, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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OCU-002

Identifier Type: -

Identifier Source: org_study_id