The Effect of Electrical Stimulation on Tear Production
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ClinicalTrials.gov Identifier: NCT01630291 |
Recruitment Status :
Completed
First Posted : June 28, 2012
Last Update Posted : December 10, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dry Eye | Device: Electrode device | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 4 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Non-Randomized, Open-Label Study to Determine the Effect of Electrical Stimulation on Tear Production |
Study Start Date : | July 2012 |
Actual Primary Completion Date : | July 2012 |
Actual Study Completion Date : | July 2012 |
Arm | Intervention/treatment |
---|---|
Experimental: Electrical stimulation |
Device: Electrode device
Lacrimal gland stimulation
Other Name: External Neurostimulator Trialing System (Medtronic) |
- Schirmer Score [ Time Frame: Up to 16 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630291
Mexico | |
APEC | |
La Concepcion, Distrito Federal, Mexico, 04030 |
Principal Investigator: | Guillermo Salcedo, M.D. | Asociación para Evitar la Ceguera en México |
Responsible Party: | Oculeve, Inc. |
ClinicalTrials.gov Identifier: | NCT01630291 |
Other Study ID Numbers: |
OCU-002 |
First Posted: | June 28, 2012 Key Record Dates |
Last Update Posted: | December 10, 2014 |
Last Verified: | December 2014 |