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

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, April 2008

Sponsored by:	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

U.S. FDA Resources

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 Primary Completion Date:	December 2008 (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
	Tel Aviv Sourasky Medical Center	Recruiting
	Tel Aviv, Israel
	Contact: David Varssano, MD 972-52-4266300 varssano@gmail.com
	Contact: Michael Weisbord 972-52-2209209 michaw@netvision.net.il
	Principal Investigator: David Varssano, MD

Sponsors and Collaborators

Trima, Israel Pharmaceutical Products

Investigators


Principal Investigator:	David Varssano, MD	Director, Cornea and External Disease Service, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.

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
First Received:	September 23, 2007
Last Updated:	April 15, 2008
ClinicalTrials.gov Identifier:	NCT00535054
Health Authority:	Israel: Ministry of Health

Keywords provided by Trima, Israel Pharmaceutical Products:

Dry Eye Syndrome

Study placed in the following topic categories:

Lacerations

Eye Diseases

Lacrimal Apparatus Diseases

Dry Eye Syndromes

Additional relevant MeSH terms:

Pathologic Processes

Disease

Syndrome

ClinicalTrials.gov processed this record on October 10, 2008