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.