Dry Eye
Conditions
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.
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.
Interventions
DEVICEElectrode device
Lacrimal gland stimulation
Sponsors
Oculeve, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Schirmer Score | Up to 16 days |
Countries
Mexico
Outcome results
None listed