Evaluation of the Repeated Usage of Systane Ultra Eyedrop
NCT ID: NCT01051804
Last Updated: 2012-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
57 participants
INTERVENTIONAL
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Systane Ultra
Systane Ultra Lubricant Eye Drops
Systane Ultra
Systane Ultra 1 to 2 drops per eye at least 4 times daily for 4 weeks
Optive
Optive Lubricant Eye Drops
Optive lubricant Eye Drops
Optive Lubricant Eye Drops 1 to 2 drops per eye at least 4 times daily for 4 weeks
Interventions
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Systane Ultra
Systane Ultra 1 to 2 drops per eye at least 4 times daily for 4 weeks
Optive lubricant Eye Drops
Optive Lubricant Eye Drops 1 to 2 drops per eye at least 4 times daily for 4 weeks
Eligibility Criteria
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Inclusion Criteria
* Non contact lens wearer.
* Symptomatology as defined below for the Ocular Surface Disease Index (OSDI) questionnaire:
* Score ≥13 for OSDI Questionnaire total score; AND
* Scores of at least 2 for 2 out of the 6 vision related questions of the OSDI questionnaire
* Best visual acuity of 6/9 or better in each eye.
* Willingness to adhere to the instructions set in the clinical protocol.
* Signature of the subject informed consent form.
Exclusion Criteria
* Systemic disease which might produce dry eye side effects.
* Active ocular infection.
* Use of ocular medication.
* Significant ocular anomaly.
* Previous ocular surgery
* Previous use of Restasis
* Any medical condition that might be prejudicial to the study.
* The subject, based on their knowledge, must NOT be pregnant or lactating at the time of enrolment.
* The subject, based on his/her knowledge, must NOT have an infectious disease (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. Human Immunodeficiency Virus).
* The subject, based on their knowledge, must NOT have diabetes.
18 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Other Identifiers
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SMA-09-33
Identifier Type: -
Identifier Source: org_study_id
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