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
Not Applicable
Completed
- Conditions
- Dry Eye Syndrome
- Interventions
- Other: SYSTANE® Balance Lubricant Eye Drops
- Registration Number
- NCT01223040
- Lead Sponsor
- Alcon Research
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Patients must have history of mild-moderate dry eye with use of (or desire to use) eye drops in past 6 months
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Exclusion Criteria
- 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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SYSTANE® Balance Lubricant Eye Drops SYSTANE® Balance Lubricant Eye Drops SYSTANE 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.
- Primary Outcome Measures
Name Time Method Changes in video Ocular Protection Index 10 and 55 minutes following Systane Balance instillation at Days 1 and 7. 8 days
- Secondary Outcome Measures
Name Time Method 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