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| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: David Zadok, MD | 972-8-9779358 | dzadok@yahoo.com |
| Contact: Yaakov Goldich, MD | 972-57-8157898 |
| 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 | |||||
| Trima, Israel Pharmaceutical Products |
| 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
|
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.
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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.
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| 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 |
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