An Open-Label, Single-Center Study Evaluating the Effect of Systane Balance on Video Ocular Protection Index (OPI) and Blink Patterns in Patients Diagnosed With Dry Eye
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the effect of acute and repeat dosing of Systane Balance on Video Ocular Protection Index (OPI) and Blink Patterns in a population of dry eye patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
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
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 15, 2010
CompletedFirst Posted
Study publicly available on registry
October 18, 2010
CompletedApril 10, 2012
January 1, 2012
1 month
October 15, 2010
April 7, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in video Ocular Protection Index 10 and 55 minutes following Systane Balance instillation at Days 1 and 7.
8 days
Secondary Outcomes (3)
Changes in blink pattern in subjects with mean Interblink Interval (IBI) < 3 seconds at Days 2 and 8
9 days
Fluorescein staining at Visits 1 & 3 on the Ora staining scale
9 days
Ocular Symptomology at each visit
9 days
Study Arms (1)
SYSTANE® Balance Lubricant Eye Drops
EXPERIMENTALSYSTANE Balance Lubricant Eye Drops dosed (bilaterally) in the office during each visit. Between visits 2 and 3, patients will dose 4 times per day for the 7 day period.
Interventions
Subjects will be dosed (bilaterally) in the office during each visit. Between visits 2 and 3, patients will dose 4 times per day for the 7 day period.
Eligibility Criteria
You may qualify if:
- Patients must have history of mild-moderate dry eye with use of (or desire to use) eye drops in past 6 months
You may not qualify if:
- Patients cannot wear contact lenses within 1 week prior nor during the study, and cannot have a history of hypersensitivity to any component of Systane Balance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2010
First Posted
October 18, 2010
Study Start
August 1, 2010
Primary Completion
September 1, 2010
Last Updated
April 10, 2012
Record last verified: 2012-01