The Effect of Electrical Stimulation on Tear Production

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01630291
• Other study ID #: OCU-002
• Status: Completed
• Phase: N/A
• First received: June 15, 2012
• Last updated: December 8, 2014
• Start date: July 2012
• Est. completion date: July 2012

Study information

• Verified date: December 2014
• Source: Oculeve, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye

Intervention

Device:
• Electrode device
Lacrimal gland stimulation

Locations

Country	Name	City	State
Mexico	APEC	La Concepcion	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Oculeve, Inc.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Schirmer Score		Up to 16 days	No