Study to Assess the Safety and Patients' Satisfaction of Tears Again* in the Treatment of Dry Eye Symptoms

This study is currently recruiting participants.

Verified by Trima, Israel Pharmaceutical Products, June 2009

First Received: September 23, 2007 Last Updated: June 7, 2009 History of Changes

Sponsor:	Trima, Israel Pharmaceutical Products
Information provided by:	Trima, Israel Pharmaceutical Products
ClinicalTrials.gov Identifier:	NCT00535054

Purpose

The purpose of this study is to determine safety and patients' satisfaction when using Tears Again to treat Dry Eye Symptoms.

Condition	Intervention
Dry Eye Syndrome	Drug: Tears Again

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	An Open Study to Assess the Safety and Patients' Satisfaction Tears Again* in the Treatment of Dry Eye Symptoms

Further study details as provided by Trima, Israel Pharmaceutical Products:

Primary Outcome Measures:

Schirmer Test, Lissamine Green Test and BUT. [ Time Frame: On enrollment and one month later. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Questionaire [ Time Frame: One, three and four weeks after treatment commencement. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	125
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Tears Again: Experimental All subjects shall be treated with Tears Again.	Drug: Tears Again Liposome Eye Spray

Eligibility

Ages Eligible for Study:	25 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Suffer from at least two of the following ocular symptoms: burning, stinging, excessive tearing, dryness, grittiness, foreign body sensation ( including patients suffering from blepharitis).
Use artificial tears or any other treatment for these symptoms three or more times a day.

Exclusion Criteria:

Known hypersensitivity to Phenoxyethanol.
Pregnant and lactating women.
Receive other ophthalmic medication (except for eyelid hygiene preparations).
Graft-versus-host disease patients.
Participated during the last month in another clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00535054

Contacts

Contact: David Zadok, MD	972-8-9779358	dzadok@yahoo.com
Contact: Yaakov Goldich, MD	972-57-8157898

Locations

Israel
Department of Ophthalmology, Assaf Harofeh Medical Center,	Recruiting
Zerifin, Israel
Contact: David Zadok, MD 972-8-9779358 dzadok@yahoo.com
Contact: Yaakov Goldich, MD 972-8-9779358 doctor.goldich@gmail.com
Principal Investigator: David MD Zadok, MD

Sponsors and Collaborators

Trima, Israel Pharmaceutical Products

Investigators

Principal Investigator:

David Zadok, MD

Department of Ophthalmology, Assaf Harofeh Medical Center,

More Information

Publications:

Lee S, Dausch S, Maierhofer G, Dausch D. [A new therapy concept for the treatment of dry eye--the usefulness of phospholipid liposomes] Klin Monatsbl Augenheilkd. 2004 Oct;221(10):825-36. German.

Dausch D, Lee S. Dausch S. Kim JC, Schwert G. Michelson W., Comparative Study of Treatment of the Dry Eye Syndrome due to Disturbances of the tear Film Layer with Lipid-Containing Tear Substitutes, Klin. Monatsbl. Alugenheiikd. 2006 Dec;223(12):974-83 3.

Responsible Party:	Department of Ophthalmology, Assaf Harofeh Medical Center,Zerifin, Israel ( David Zadok, MD )
Study ID Numbers:	06.11
Study First Received:	September 23, 2007
Last Updated:	June 7, 2009
ClinicalTrials.gov Identifier:	NCT00535054 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Trima, Israel Pharmaceutical Products:

Dry Eye Syndrome

Additional relevant MeSH terms:

Pathologic Processes
Disease
Eye Diseases

Syndrome
Lacrimal Apparatus Diseases
Dry Eye Syndromes

ClinicalTrials.gov processed this record on November 27, 2009