Pilot Study to Clinical Evaluate Device Prototypes in Dry Eye Patients

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by Lacrima Medical LTD
Sponsor:
Information provided by (Responsible Party):
Lacrima Medical LTD
ClinicalTrials.gov Identifier:
NCT01957670
First received: September 30, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted
  Purpose

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


Condition Intervention
Dry Eye Syndrome
Device: Lacrima medical Prototypes

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot, Open-label, Single-Arm Study Designed to Clinically Evaluate Various Lacrima Medical Device Prototypes in Adult Patients With Dry Eye Syndrome

Resource links provided by NLM:


Further study details as provided by Lacrima Medical LTD:

Primary Outcome Measures:
  • Lower Tear Meniscus Height using Optical Coherence Tomography [ Time Frame: up to 8 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual Analog Scale score [ Time Frame: up to 8 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: February 2014
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment with Lacrima medical device Device: Lacrima medical Prototypes

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01957670

Contacts
Contact: Yael Kenan, Ph.D 972-3-9085028 yaelkenan@lacrima-med.com

Locations
Israel
Tel Aviv Sourasky Medical Center, Israel Not yet recruiting
Tel Aviv, Israel, 64239
Contact: Elia Levinger, MD    +972-3-6973408    dr.levinger@gmail.com   
Principal Investigator: Elia Levinger, MD         
Sponsors and Collaborators
Lacrima Medical LTD
  More Information

No publications provided

Responsible Party: Lacrima Medical LTD
ClinicalTrials.gov Identifier: NCT01957670     History of Changes
Other Study ID Numbers: LM001
Study First Received: September 30, 2013
Last Updated: September 30, 2013
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

Keywords provided by Lacrima Medical LTD:
Keratoconjunctivitis Sicca
Dry Eye Syndromes

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases

ClinicalTrials.gov processed this record on July 24, 2014