| Eye
Sting |
| Outline: |
Comparative
Eye Sting Study |
| Objective: |
To
determine if a "tear-free" claim can be substantiated
for a product.
|
| Subjects: |
20
healthy volunteers
|
| Timing: |
1-day
test
Start within 2 weeks of the time the test material is received
|
| Quantity: |
8
oz. |
|
Methodology: |
Clinical
assessment by a Board Certified Ophthalmologist
Subjective assessment of pain |
|
Procedures: |
All
subjects are examined by the Ophthalmologist for signs of irritation,
redness and tearing. A trained technician then instills a drop of
the diluted test article into one eye and a competitive control into
the other eye of each subject. Each instillation takes place 5 minutes
apart. After each instillation the subject evaluates the "sting"
of each material based on a 6-point scale. The Ophthalmologist also
examines each subject post-instillation for changes in irritation,
redness and tearing. Range-finding studies with progressive increases
in aqueous concentrations are also available.
|