Pilot Study to Clinical Evaluate Device Prototypes in Dry Eye Patients

Lacrima Medical

Status: Withdrawn

Conditions: Dry Eye Syndrome

Treatments: Device: Lacrima medical Prototypes

Study type: Interventional

Funder types: Industry

Identifiers

NCT01957670

LM001

Details and patient eligibility

About

The study will assess the safety, tolerability and feasibility of Lacrima investigational medical device to treat dry eye patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Treatment with Lacrima medical device

Experimental group

Treatment:

Device: Lacrima medical Prototypes