Back to resultsPilot Study to Clinical Evaluate Device Prototypes in Dry Eye Patients
Primary Purpose
Dry Eye Syndrome
Status
Withdrawn
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Lacrima medical Prototypes
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndrome focused on measuring Keratoconjunctivitis Sicca, Dry Eye Syndromes
Eligibility Criteria
Main Inclusion Criteria:
- Male or female, 18 years of age and over at screening
Diagnosis of mild to moderate Dry Eye, as defined by:
- 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
- Schirmer Test score (with anesthesia, 5 minutes < 5 mm either eye) ; AND
- OSDI score of ≥12 and OSDI score of <33
Main Exclusion Criteria:
- Persistent intraocular inflammation or infection including conjunctivitis at the time of the study or 2 weeks prior to study start.
- 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
- Patients currently using topical steroidal or anti-inflammatory eye drops for 1 month prior to screening
- Receipt of any type of topical artificial eye drops within 3 days prior to screening
- Receipt of topical cyclosporine eye drops within 3 months prior to screening
Sites / Locations
- Tel Aviv Sourasky Medical Center, Israel
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment with Lacrima medical device
Arm Description
Outcomes
Primary Outcome Measures
Lower Tear Meniscus Height using Optical Coherence Tomography
Secondary Outcome Measures
Visual Analog Scale score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01957670
Brief Title
Pilot Study to Clinical Evaluate Device Prototypes in Dry Eye Patients
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 Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor decision due to change the clinical indication to Chronic Insomnia
Study Start Date
February 2014 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
April 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lacrima Medical LTD
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will assess the safety, tolerability and feasibility of Lacrima investigational medical device to treat dry eye patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome
Keywords
Keratoconjunctivitis Sicca, Dry Eye Syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment with Lacrima medical device
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Lacrima medical Prototypes
Primary Outcome Measure Information:
Title
Lower Tear Meniscus Height using Optical Coherence Tomography
Time Frame
up to 8 hours
Secondary Outcome Measure Information:
Title
Visual Analog Scale score
Time Frame
up to 8 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria:
Male or female, 18 years of age and over at screening
Diagnosis of mild to moderate Dry Eye, as defined by:
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
Schirmer Test score (with anesthesia, 5 minutes < 5 mm either eye) ; AND
OSDI score of ≥12 and OSDI score of <33
Main Exclusion Criteria:
Persistent intraocular inflammation or infection including conjunctivitis at the time of the study or 2 weeks prior to study start.
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
Patients currently using topical steroidal or anti-inflammatory eye drops for 1 month prior to screening
Receipt of any type of topical artificial eye drops within 3 days prior to screening
Receipt of topical cyclosporine eye drops within 3 months prior to screening
Facility Information:
Facility Name
Tel Aviv Sourasky Medical Center, Israel
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Pilot Study to Clinical Evaluate Device Prototypes in Dry Eye Patients
We'll reach out to this number within 24 hrs