Evaluation of SYSTANE Ultra Lubricant Eye Drops
1 other identifier
interventional
109
1 country
1
Brief Summary
To evaluate the safety and efficacy of two artificial tears in dry eye patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 19, 2008
CompletedFirst Posted
Study publicly available on registry
June 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedResults Posted
Study results publicly available
February 10, 2010
CompletedFebruary 2, 2012
January 1, 2012
3 months
June 19, 2008
September 23, 2009
January 31, 2012
Conditions
Outcome Measures
Primary Outcomes (3)
Tear Break-up Time
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.
Day 0, Day 7, Day 14, Day 28, and Day 42
Conjunctival Staining
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.
Day 0, Day 7, Day 14, Day 28, Day 42
Corneal Staining
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.
Day 0, Day 7, Day 14, Day 28, Day 42
Study Arms (2)
SYSTANE Ultra
EXPERIMENTALSYSTANE Ultra Lubricant Eye Drops
OPTIVE
ACTIVE COMPARATOROPTIVE Lubricant Eye Drops
Interventions
SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
Eligibility Criteria
You may qualify if:
- Documented diagnosis of dry eyes
- Must not have worn contact lenses for 1 week preceding enrollment
You may not qualify if:
- Age related
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (1)
Contact Call Center for Locations
Fort Worth, Texas, 76134, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alcon Clinical
- Organization
- Alcon Research Ltd
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2008
First Posted
June 20, 2008
Study Start
June 1, 2008
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
February 2, 2012
Results First Posted
February 10, 2010
Record last verified: 2012-01