Evaluation of the Repeated Usage of Systane Ultra Eyedrop

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research

ClinicalTrials.gov Identifier:

NCT01051804

First received: January 18, 2010

Last updated: January 31, 2012

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 18, 2010
Last Updated Date	January 31, 2012
Start Date ^ICMJE	November 2009
Primary Completion Date	July 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 19, 2010)	Improvement in objective vision [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01051804 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 19, 2010)	Measurement of tear film evaporation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluation of the Repeated Usage of Systane Ultra Eyedrop
Official Title ^ICMJE	Not Provided
Brief Summary	Comparison of two contact lens solutions.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Caregiver) Primary Purpose: Treatment
Condition ^ICMJE	Dry Eye
Intervention ^ICMJE	Other: Systane Ultra Systane Ultra 1 to 2 drops per eye at least 4 times daily for 4 weeks Other: Optive lubricant Eye Drops Optive Lubricant Eye Drops 1 to 2 drops per eye at least 4 times daily for 4 weeks
Study Arm (s)	Experimental: Systane Ultra Systane Ultra Lubricant Eye Drops Intervention: Other: Systane Ultra Active Comparator: Optive Optive Lubricant Eye Drops Intervention: Other: Optive lubricant Eye Drops
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	57
Completion Date	Not Provided
Primary Completion Date	July 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Age 18 years or more. 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: Use of systemic medication which might produce dry eye side effects. 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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01051804
Other Study ID Numbers ^ICMJE	SMA-09-33
Has Data Monitoring Committee	No
Responsible Party	Alcon Research
Study Sponsor ^ICMJE	Alcon Research
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alcon Research
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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