- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00702377
Evaluation of SYSTANE Ultra Lubricant Eye Drops
January 31, 2012 updated by: Alcon Research
To evaluate the safety and efficacy of two artificial tears in dry eye patients.
Study Overview
Study Type
Interventional
Enrollment (Actual)
109
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Fort Worth, Texas, United States, 76134
- Contact Call Center for Locations
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Documented diagnosis of dry eyes
- Must not have worn contact lenses for 1 week preceding enrollment
Exclusion Criteria:
- Age related
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SYSTANE Ultra
SYSTANE Ultra Lubricant Eye Drops
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SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
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Active Comparator: OPTIVE
OPTIVE Lubricant Eye Drops
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Optive Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Day 0, Day 7, Day 14, Day 28, and Day 42
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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.
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Day 0, Day 7, Day 14, Day 28, Day 42
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Corneal Staining
Time Frame: Day 0, Day 7, Day 14, Day 28, Day 42
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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.
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Day 0, Day 7, Day 14, Day 28, Day 42
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
June 19, 2008
First Submitted That Met QC Criteria
June 19, 2008
First Posted (Estimate)
June 20, 2008
Study Record Updates
Last Update Posted (Estimate)
February 2, 2012
Last Update Submitted That Met QC Criteria
January 31, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-07-33
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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