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

• Sponsor: Trima, Israel Pharmaceutical Products (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00535054
• Collaborator: (none)
• Enrollment: 125
• Location: 1
• Arm: 1
• Duration (Months): 29
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndrome	Drug: Tears Again	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 125 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Sep 1, 2007
• Actual Primary Completion Date: Feb 1, 2010
• Actual Study Completion Date: Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tears Again All subjects shall be treated with Tears Again.	Drug: Tears Again; Liposome Eye Spray

Outcome Measures

Primary Outcome Measures

1. Schirmer Test, Lissamine Green Test and BUT. [On enrollment and one month later.]

Secondary Outcome Measures

1. Questionaire [One, three and four weeks after treatment commencement.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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,

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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 lipid layer with lipid-containing tear substitutes]. Klin Monbl Augenheilkd. 2006 Dec;223(12):974-83. German.
• Lee S, Dausch S, Maierhofer G, Dausch D. [A new therapy concept for the treatment of dry eye--the usefulness of phospholipid liposomes]. Klin Monbl Augenheilkd. 2004 Oct;221(10):825-36. German.

• ClinicalTrials.gov Identifier: NCT00535054
• Other Study ID Numbers: 06.11
• First Posted: Sep 26, 2007
• Last Update Posted: Feb 9, 2010
• Last Verified: Feb 1, 2010

• Keywords provided by , ,: Dry Eye Syndrome
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca

Study Results

No Results Posted as of Feb 9, 2010