The Effect of Electrical Stimulation on Tear Production
This study is currently recruiting participants.
Verified July 2012 by Oculeve, Inc.
Sponsor:
Oculeve, Inc.
Information provided by (Responsible Party):
Oculeve, Inc.
ClinicalTrials.gov Identifier:
NCT01630291
First received: June 15, 2012
Last updated: July 16, 2012
Last verified: July 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Dry Eye |
Device: Electrode device |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Non-Randomized, Open-Label Study to Determine the Effect of Electrical Stimulation on Tear Production |
Further study details as provided by Oculeve, Inc.:
Primary Outcome Measures:
- Schirmer Score [ Time Frame: Up to 16 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Electrical stimulation |
Device: Electrode device
Lacrimal gland stimulation
Other Name: External Neurostimulator Trialing System (Medtronic)
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01630291
Contacts
| Contact: Michael Ackermann, PhD | 650-735-2017 | d.michael.ackermann@gmail.com |
Locations
| Mexico | |
| APEC | Recruiting |
| La Concepcion, Distrito Federal, Mexico, 04030 | |
| Contact: Michael D. Ackermann, PhD 650-735-2017 d.michael.ackermann@gmain.com | |
| Principal Investigator: Guillermo Salcedo Casillas, M.D. | |
Sponsors and Collaborators
Oculeve, Inc.
Investigators
| Principal Investigator: | Guillermo Salcedo, M.D. | Asociacion Para Evitar la Ceguera en Mexico |
More Information
No publications provided
| Responsible Party: | Oculeve, Inc. |
| ClinicalTrials.gov Identifier: | NCT01630291 History of Changes |
| Other Study ID Numbers: | OCU-002 |
| Study First Received: | June 15, 2012 |
| Last Updated: | July 16, 2012 |
| Health Authority: | Mexico: Ethics Committee |
ClinicalTrials.gov processed this record on May 21, 2013