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

This study has been completed.
Information provided by:
Trima, Israel Pharmaceutical Products Identifier:
First received: September 23, 2007
Last updated: February 7, 2010
Last verified: February 2010
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

Resource links provided by NLM:

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. ]

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

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


Ages Eligible for Study:   25 Years to 85 Years   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT00535054

Department of Ophthalmology, Assaf Harofeh Medical Center,
Zerifin, Israel
Sponsors and Collaborators
Trima, Israel Pharmaceutical Products
Principal Investigator: David Zadok, MD Department of Ophthalmology, Assaf Harofeh Medical Center,
  More Information

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

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

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases processed this record on May 23, 2017