The Effect of Electrical Stimulation on Tear Production

Oculeve

Status: Completed

Conditions: Dry Eye

Treatments: Device: Electrode device

Study type: Interventional

Funder types: Industry

Identifiers

NCT01630291

OCU-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Electrical stimulation

Experimental group

Treatment:

Device: Electrode device