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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00535054
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : February 9, 2010
Sponsor:
Information provided by:
Trima, Israel Pharmaceutical Products

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
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 : September 2007
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Schirmer Test, Lissamine Green Test and BUT. [ Time Frame: On enrollment and one month later. ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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,

Publications:
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
First Posted: September 26, 2007    Key Record Dates
Last Update Posted: February 9, 2010
Last Verified: February 2010

Keywords provided by Trima, Israel Pharmaceutical Products:
Dry Eye Syndrome

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases