Evaluation of the Irritation Potential of Products in Human Eyes.

Study Overview
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Brief Summary
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To evaluate the human eye irritation potential of two test sunscreen formulation

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

Conditions
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Sunscreening Agents

Intervention / Treatment
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* Other: Sunscreen Spray SPF50 Z15-034(BAY987516)
* Other: Shampoo Control
* Other: Sunscreen Spray SPF50 Z15-038(BAY987516)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be healthy males or females between the ages of 18 to 60 years inclusive with no medical conditions of the eyes. Do not wear contact lenses or, if he/she does wear contact lenses, is willing to refrain from wearing these during the test period. Willing to report any medications taken during the study. Willing to have the test materials instilled into the eyes and follow all protocol requirements. Have been informed and have given written consent to participate in the study. Exclusion Criteria: Has ocular disease or peri-orbital dermatitis or trauma, infections or chronic eye conditions that may affect the study outcome. Has systemic illness which affects the eyes, including diabetes, thyroid disease, sarcoidosis, hypertension, atherosclerosis, lupus, multiple sclerosis, sickle cell disease, acquired immune deficiency syndrome (AIDs), severer rheumatoid arthritis. results as determined by the investigator. Must not have a history of pre-existing sensitivity or other types of allergy to any eye products. Must not have received and used an Investigational New Drug within the thirty days immediately preceding the study.

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sun Protection Factor (SPF) 50 Z15-034(BAY987516)<br>Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule. | Other: Sunscreen Spray SPF50 Z15-034(BAY987516)<br>* Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.<br>Other: Shampoo Control<br>* Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.<br>|
| Experimental: Sunscreen Spray SPF50 Z15-038(BAY987516)<br>Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule. | Other: Shampoo Control<br>* Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.<br>Other: Sunscreen Spray SPF50 Z15-038(BAY987516)<br>* Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective assessment of discomfort in the eyes assessed by 5 point scale |  | Up to 1 day | 
| Intensity of Lacrimation assessed by 5 grading scale |  | Up to 1 day | 
| Intensity of Bulbar Conjunctiva Irritation assessed by 4 grading scale |  | Up to 1 day | 
| Intensity of Palpebral Conjunctiva Irritation assessed by 4 grading scale |  | Up to 1 day |