Study Stopped
Sponsor decision due to change the clinical indication to Chronic Insomnia
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
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The study will assess the safety, tolerability and feasibility of Lacrima investigational medical device to treat dry eye patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2013
CompletedFirst Posted
Study publicly available on registry
October 8, 2013
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedMarch 8, 2016
March 1, 2016
2.2 years
September 30, 2013
March 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lower Tear Meniscus Height using Optical Coherence Tomography
up to 8 hours
Secondary Outcomes (1)
Visual Analog Scale score
up to 8 hours
Study Arms (1)
Treatment with Lacrima medical device
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tel Aviv Sourasky Medical Center, Israel
Tel Aviv, 64239, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2013
First Posted
October 8, 2013
Study Start
February 1, 2014
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
March 8, 2016
Record last verified: 2016-03