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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00535054 |
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Date of registration:
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23/09/2007 |
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Primary sponsor: |
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Public title:
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Study to Assess the Safety and Patients' Satisfaction of Tears Again* in the Treatment of Dry Eye Symptoms
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Scientific title:
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An Open Study to Assess the Safety and Patients' Satisfaction Tears Again* in the Treatment of Dry Eye Symptoms |
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Date of first enrolment:
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September 2007 |
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Target sample size:
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125 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00535054 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Israel
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Contacts
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Name:
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David Zadok, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Ophthalmology, Assaf Harofeh Medical Center, |
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Key inclusion & exclusion criteria
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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.
Age minimum:
25 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dry Eye Syndrome
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Intervention(s)
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Drug: Tears Again
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Primary Outcome(s)
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Schirmer Test, Lissamine Green Test and BUT.
[Time Frame: On enrollment and one month later.]
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Secondary Outcome(s)
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Questionaire
[Time Frame: One, three and four weeks after treatment commencement.]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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