| Ophthalmologic
Safety |
| Outline: |
Ophthalmologic
Safety-In-Use |
| Objective: |
To
determine eye irritation potential of a test article under actual
use conditions.
|
| Subjects: |
30
healthy volunteers
50% contact lens wearers (if requested by Sponsor)
|
| Timing: |
2 week
test
Start within 2 weeks of the time the test material is received.
|
| Quantity: |
Clinical
assessment by a Board Certified Ophthalmologist |
|
Methodology: |
35
individual containers with enough product to last for at least 2 weeks
actual use conditions |
| Claims: |
Ophthalmologist
Tested
Safe for Contact Lens Wearers |
|
Procedures: |
On
study day 1, the Medical Investigator (a Board Certified Opthalmologist)
examines approximately 30 subjects to determine their eligibility
for the study. This exam includes upper and lower eyelashes and margins,
conjunctivae, visible corneal anomolies, slit lamp examinations and
a general exam of the periorbital area of the eyes. Enrolled subjects
are then given the product to use at home for 2 weeks, use instructions
and a daily diary to record time of usage as well as any other significant
comments. After one week, subjects call the testing facility. After
2 weeks, they return for a follow-up exam by the Ophthalmologist.
|