Dry Eye Syndrome
Conditions
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.
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.
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have history of mild-moderate dry eye with use of (or desire to use) eye drops in past 6 months
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in video Ocular Protection Index 10 and 55 minutes following Systane Balance instillation at Days 1 and 7. | 8 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed