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The objective of this study was to compare the human eye stinging potential of experimental formulas and an industry standard shampoo mixture. The study was conducted under the supervision of a Board Certified Ophthalmologist. The study design was a three cell, single blind study. Subjects were given the industry standard shampoo mixture in one eye and an exploratory sunscreen in the other as according to the randomization schedule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suncare agent A + control | Experimental | Application of control and test product into one of the subjects two eyes. |
|
| Suncare agent B + control | Experimental | Application of control and test product into one of the subjects two eyes. |
|
| Suncare agent C + control | Experimental | Application of control and test product into one of the subjects two eyes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY987516, Y55-170 | Drug | 10 uL in one eye |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective discomfort in the eye was assessed based on questions by an Ophthalmologist to the subject using a 5-category intensity scale | up to 24 hours after instillation | |
| Tearing/Lacrimation was assessed by the Ophthalmologist using a 5-category assessment score | up to 24 hours after instillation | |
| Objective inflammation was assessed by the Ophthalmologist using a 5-category assessment score | up to 24 hours after instillation | |
| Post installation eye effects were assessed using a 5-category intensity score | up to 24 hours after instillation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events as a measure of safety and tolerability | at 24 hours |
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Inclusion 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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| Label | URL |
|---|---|
| Related Info | View source |
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| BAY987516, X72-151 |
| Drug |
10 uL in one eye |
|
| BAY987516, Y49-034 | Drug | 10 uL in one eye |
|
| Standard shampoo mixture (control) | Drug | 10 uL in one eye |
|