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To evaluate the human eye irritation potential of one test sunscreen formulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sunscreen lotion Sun Protection Factor 50 (BAY987521) | Experimental | Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule. |
|
| Ophthalmic Ointment | Other | Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunscreen lotion SPF (Sun Protection Factor) 50 (BAY987521) | Other | Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Petersburg | Florida | 33714 | United States |
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| ID | Term |
|---|---|
| D059405 | Sun Protection Factor |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D011874 | Radiometry |
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| Ophthalmic Ointment | Other | Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule. |
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