Dry Eye Syndrome
Conditions
Keywords
Keratoconjunctivitis Sicca, Dry Eye Syndromes
Brief summary
The study will assess the safety, tolerability and feasibility of Lacrima investigational medical device to treat dry eye patients
Interventions
DEVICELacrima medical Prototypes
Sponsors
Lacrima Medical LTD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: 1. Male or female, 18 years of age and over at screening 2. Diagnosis of mild to moderate Dry Eye, as defined by: 1. Positive corneal fluorescein staining , defined as a corneal punctate fluorescein staining score of ≥3 in either eye by the National Eye Institute evaluation scale summed over 5 areas, each with a 0-3 scoring scale; AND 2. Schirmer Test score (with anesthesia, 5 minutes \< 5 mm either eye) ; AND 3. OSDI score of ≥12 and OSDI score of \<33 Main
Exclusion criteria
1. Persistent intraocular inflammation or infection including conjunctivitis at the time of the study or 2 weeks prior to study start. 2. Any concomitant active or history of eye disease including, but not limited to lid abnormalities, nasolacrimal obstruction, active ulcer, glaucoma or ocular herpes simplex virus infection 3. Patients currently using topical steroidal or anti-inflammatory eye drops for 1 month prior to screening 4. Receipt of any type of topical artificial eye drops within 3 days prior to screening 5. Receipt of topical cyclosporine eye drops within 3 months prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lower Tear Meniscus Height using Optical Coherence Tomography | up to 8 hours |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analog Scale score | up to 8 hours |
Countries
Israel
Outcome results
None listed