To Evaluate the Physical Effects of Systane(R) Lubricant Eye Drops Compared to Refresh Tears(R) Lubricant Eye Drops

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research

ClinicalTrials.gov Identifier:

NCT01160133

First received: July 9, 2010

Last updated: April 7, 2012

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 9, 2010
Last Updated Date	April 7, 2012
Start Date ^ICMJE	July 2010
Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 9, 2010)	To evaluate physical effects of Systane and Refresh Tears in subjects to moderate to severe dry eye. [ Time Frame: Baseline to visit 3 (Day 42) ] [ Designated as safety issue: Yes ] This is a descriptive study in which changes from baseline in Tear Break up Time, corneal staining, and the Ocular Symptoms Questionnaire will be evaluated by treatment group at every visit. The outcome of the IDEEL questionnaire at Visit 3 will be compared to Visit 1 by treatment group; the results of treatment satisfaction questionnaires will be tabulated by treatment at Visit 3.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01160133 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	To Evaluate the Physical Effects of Systane(R) Lubricant Eye Drops Compared to Refresh Tears(R) Lubricant Eye Drops
Official Title ^ICMJE	Not Provided
Brief Summary	This is a multi-site, randomized, investigator-masked study to evaluate the physical effects of Systane(R) versus Refresh Tears(R) in subjects with moderate to severe dry eye. It is a 6-week, perspective, randomized, active-controlled, investigator-masked, parallel group study.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Dry Eye
Intervention ^ICMJE	Other: Systane Systane Lubricant Eye Drops (1-2 drops in each eye, four times per day) Other: Refresh Tears Refresh Tears Lubricant Eye Drops (1-2 drops in each eye, four times per day)
Study Arm (s)	Experimental: Systane Systane Lubricant Eye Drops Intervention: Other: Systane Experimental: Refresh Tears Refresh Tears Lubricant Eye Drops Intervention: Other: Refresh Tears
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	78
Completion Date	June 2011
Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patient must be 18 years of age or older of any sex and any race, with a score of at least 2 (some of the time) on the subject-assessed Symptom Eligibility question. A sodium fluorescein corneal staining sum of ≥ 3 in either eye. A best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed using an ETDRS chart. Exclusion Criteria: A history or evidence of ocular or intraocular surgery in either eye within the past 6 months. Lasik patients can be included if lasik surgery was greater than 6 months prior to the initiation of the study. A history of intolerance or hypersensitivity to any component of the study medications.
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	India

Administrative Information
NCT Number ^ICMJE	NCT01160133
Other Study ID Numbers ^ICMJE	SMA-09-67
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

To Top