NCT01630291

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 28, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

December 10, 2014

Status Verified

December 1, 2014

Enrollment Period

Same day

First QC Date

June 15, 2012

Last Update Submit

December 8, 2014

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • Schirmer Score

    Up to 16 days

Study Arms (1)

Electrical stimulation

EXPERIMENTAL
Device: Electrode device

Interventions

Electrode deviceDEVICE

Lacrimal gland stimulation

Also known as: External Neurostimulator Trialing System (Medtronic)
Electrical stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

APEC

La Concepción, Mexico City, 04030, Mexico

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Electrodes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Electrical Equipment and SuppliesEquipment and Supplies

Study Officials

  • Guillermo Salcedo, M.D.

    Asociación para Evitar la Ceguera en México

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2012

First Posted

June 28, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

December 10, 2014

Record last verified: 2014-12

Locations

ME(1)