Pilot Study to Clinical Evaluate Device Prototypes in Dry Eye Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01957670
Recruitment Status : Withdrawn (Sponsor decision due to change the clinical indication to Chronic Insomnia)
First Posted : October 8, 2013
Last Update Posted : March 8, 2016
Information provided by (Responsible Party):
Lacrima Medical LTD

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

Condition or disease Intervention/treatment Phase
Dry Eye Syndrome Device: Lacrima medical Prototypes Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2014
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : April 2016

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

Primary Outcome Measures :
  1. Lower Tear Meniscus Height using Optical Coherence Tomography [ Time Frame: up to 8 hours ]

Secondary Outcome Measures :
  1. Visual Analog Scale score [ Time Frame: up to 8 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01957670

Tel Aviv Sourasky Medical Center, Israel
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Lacrima Medical LTD

Responsible Party: Lacrima Medical LTD Identifier: NCT01957670     History of Changes
Other Study ID Numbers: LM001
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: March 2016

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

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Pathologic Processes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases