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

This study has been completed.

First Received on September 23, 2007. Last Updated on February 7, 2010 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:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Tears Again 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

Locations

Israel
Department of Ophthalmology, Assaf Harofeh Medical Center,
Zerifin, Israel

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:	David Zadok, MD, Department of Ophthalmology, Assaf Harofeh Medical Center,Zerifin, Israel
ClinicalTrials.gov Identifier:	NCT00535054 History of Changes
Other Study ID Numbers:	06.11
Study First Received:	September 23, 2007
Last Updated:	February 7, 2010
Health Authority:	Israel: Ministry of Health

Keywords provided by Trima, Israel Pharmaceutical Products:

Dry Eye Syndrome

Additional relevant MeSH terms:

Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases

Keratitis
Corneal Diseases
Carboxymethylcellulose Sodium
Laxatives
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012