Evaluation of SYSTANE Ultra Lubricant Eye Drops
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00702377|
Recruitment Status : Completed
First Posted : June 20, 2008
Results First Posted : February 10, 2010
Last Update Posted : February 2, 2012
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye||Other: SYSTANE Ultra Other: Optive||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||109 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||September 2008|
Experimental: SYSTANE Ultra
SYSTANE Ultra Lubricant Eye Drops
Other: SYSTANE Ultra
SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
Active Comparator: OPTIVE
OPTIVE Lubricant Eye Drops
Optive Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
- Tear Break-up Time [ Time Frame: Day 0, Day 7, Day 14, Day 28, and Day 42 ]Tear breakup time is the time interval between a blink and the development of a dry spot in the tear film. Less than 10 seconds is abnormal. Dry spot is visible after fluorescein staining when viewed under a slit-lamp.
- Conjunctival Staining [ Time Frame: Day 0, Day 7, Day 14, Day 28, Day 42 ]Conjunctival staining refers to the appearance of spots on the conjunctiva when dyed with lissamine green stain during an eye examination. Lissamine green temporarily stains the surface of the conjunctiva of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the spots as green spots. Conjunctival staining grading scale is a 6 point scale, with 0 equals no staining (best case) and 6 equals maximum (worst) staining.
- Corneal Staining [ Time Frame: Day 0, Day 7, Day 14, Day 28, Day 42 ]Corneal staining refers to the appearance of corneal abrasions when dyed with fluorescein drops during an eye examination. Fluorescein temporarily stains the surface of the cornea of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the abrasions as brightly-colored spots on an otherwise smooth cornea. Corneal staining grading scale is a 15 point scale, with 0 equals no staining (best case) and 15 equals maximum (worst) staining.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00702377
|United States, Texas|
|Contact Call Center for Locations|
|Fort Worth, Texas, United States, 76134|