Pilot Study to Clinical Evaluate Device Prototypes in Dry Eye Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 11 April 2016
• Main ID: NCT01957670
• Date of registration: 30/09/2013
• Prospective Registration: Yes
• Primary sponsor: Lacrima Medical LTD
• Public title: Pilot Study to Clinical Evaluate Device Prototypes in Dry Eye Patients
• Scientific title: Pilot, Open-label, Single-Arm Study Designed to Clinically Evaluate Various Lacrima Medical Device Prototypes in Adult Patients With Dry Eye Syndrome
• Date of first enrolment: February 2014
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT01957670
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Israel

Key inclusion & 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



Age minimum: 18 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Dry Eye Syndrome

Intervention(s)

Device: Lacrima medical Prototypes

Primary Outcome(s)

Lower Tear Meniscus Height using Optical Coherence Tomography [Time Frame: up to 8 hours]

Secondary Outcome(s)

Visual Analog Scale score [Time Frame: up to 8 hours]

Secondary ID(s)

LM001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors