Pilot Study to Clinical Evaluate Device Prototypes in Dry Eye Patients

Dry Eye Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01957670
• Other study ID #: LM001
• Status: Withdrawn
• Phase: N/A
• First received: September 30, 2013
• Last updated: March 6, 2016
• Start date: February 2014
• Est. completion date: April 2016

Study information

• Verified date: March 2016
• Source: Lacrima Medical LTD
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Device:
• Lacrima medical Prototypes

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center, Israel	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Lacrima Medical LTD

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower Tear Meniscus Height using Optical Coherence Tomography		up to 8 hours	No
Secondary	Visual Analog Scale score		up to 8 hours	Yes