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

Tracking Information

First Received Date ^ICMJE

September 23, 2007

Last Updated Date

June 7, 2009

Start Date ^ICMJE

September 2007

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Schirmer Test and Lissamine Green Test [ Time Frame: On enrollment and one month later. ]

Change History

Complete list of historical versions of study NCT00535054 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Questionaire [ Time Frame: One, three and four weeks after treatment commencement. ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Single Group Assignment

Condition ^ICMJE

Dry Eye Syndrome

Intervention ^ICMJE

Drug: Tears Again

Study Arms / Comparison Groups

Experimental: All subjects shall be treated with Tears Again.

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

125

Estimated Completion Date

December 2009

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

25 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Israel

Administrative Information

NCT ID ^ICMJE

NCT00535054

Responsible Party

David Zadok, MD, Department of Ophthalmology, Assaf Harofeh Medical Center,Zerifin, Israel

Study ID Numbers ^ICMJE

06.11

Study Sponsor ^ICMJE

Trima, Israel Pharmaceutical Products

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

David Zadok, MD

Department of Ophthalmology, Assaf Harofeh Medical Center,

Information Provided By

Trima, Israel Pharmaceutical Products

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP