Evaluation of the Irritation Potential of Sunscreen Products in Human Eyes

Study Overview
=================
Brief Summary
-----------------
Evaluation of the human eye irritation potential of a test sunscreen formulation.

Official Title
-----------------
Evaluation of the Irritation Potential of Sunscreen Products in Human Eyes

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Drug: BAY987521
* Drug: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be healthy males or females between the ages of 18 to 60 years inclusive. Subjects do not wear contact lenses or willing to refrain from wearing them during the day of and day after the study. Subjects are willing to report any medications taken during the study and refrain from taking any medication during the study. Subjects are willing to have the test materials instilled into the eyes and follow all protocol requirements. Exclusion Criteria: Subjects have ocular disease or peri-orbital dermatitis or trauma. Subjects have a systemic illness which contra-indicates participation. Subjects must not have a history of pre-existing sensitivity or other types of allergy to any eye products. Subjects must not have a history of allergies or sensitivities to cosmetics, toiletries, dermatological products, or any ingredients contained in the test or control products.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sunscreen / Arm 1<br>Subjects will be escorted to a separate room for instillation of the test materials. Test materials will be instilled in immediate succession and with a randomized order of presentation. A trained technician will use the thumb and forefinger of one hand to retract the lower eyelid from the eyes of the subject forming sacs in the conjuntival tissue, apply one test product to one eye. | Drug: BAY987521<br>* 10 micro L of the appropriate test product is place into the lower conjunctival sac of the designated eye (Formulation code: Y49-103).<br>|
| Other: Control<br>A trained technician will use the thumb and forefinger of one hand to retract the lower eyelid from the other eyes of the subject forming sacs in the conjuntival tissue, apply control materials to this eye, follow the same procedure, using a new pipet tip or steriled dropper. | Drug: Control<br>* 10 micro L of the appropriate controlled product is place into the lower conjunctival sac of the designated eye.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macroscopic evaluations for Lacrimation (score 0-4) |  | up to 1 hour post instillation | 
| Macroscopic evaluations for Bulbar Conjuctiva Irritation (score 0-3) |  | up to 1 hour post instillation | 
| Macroscopic evaluations of Palpebral Conjunctiva Irritation (score 0-3) |  | up to 1 hour post instillation | 
| Subjective assessment of discomfort (score 0-4) |  | up to 1 hour post instillation |