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Evaluation of the human eye irritation potential of a test sunscreen formulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sunscreen / Arm 1 | Experimental | 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. |
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| Control | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY987521 | Drug | 10 micro L of the appropriate test product is place into the lower conjunctival sac of the designated eye (Formulation code: Y49-103). |
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| 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 |
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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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| Control | Drug | 10 micro L of the appropriate controlled product is place into the lower conjunctival sac of the designated eye. |
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