Pilot Study to Clinical Evaluate Device Prototypes in Dry Eye Patients

Pilot, Open-label, Single-Arm Study Designed to Clinically Evaluate Various Lacrima Medical Device Prototypes in Adult Patients With Dry Eye Syndrome

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

Study Overview

• Status: Withdrawn
• Conditions: Dry Eye Syndrome
• Intervention / Treatment: Device: Lacrima medical Prototypes

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel, 64239
    • Tel Aviv Sourasky Medical Center, Israel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with Lacrima medical device	Device: Lacrima medical Prototypes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Lower Tear Meniscus Height using Optical Coherence Tomography	up to 8 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Visual Analog Scale score	up to 8 hours

Collaborators and Investigators

• Sponsor: Lacrima Medical LTD

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Anticipated): April 1, 2016
• Study Completion (Anticipated): April 1, 2016

Study Registration Dates

• First Submitted: September 30, 2013
• First Submitted That Met QC Criteria: September 30, 2013
• First Posted (Estimate): October 8, 2013

Study Record Updates

• Last Update Posted (Estimate): March 8, 2016
• Last Update Submitted That Met QC Criteria: March 6, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: LM001