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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suncare agent 1 + control | Experimental | Application of control and test product into one of the subjects two eyes. |
|
| Suncare agent 2 + control | Experimental | Application of control and test product into one of the subjects two eyes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY 987516 (Y65-122) | Drug | 5 µL in one eye |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective discomfort in the eye was assessed based on questions by an Ophthalmologist to the subject, and a 5-category intensity scale. | up to 24 hours | |
| Tearing/Lacrimation was assessed by the Ophthalmologist using a 5-category assessment score for each of the categories | up to 24 hours | |
| Objective inflammation was assessed by the Ophthalmologist using a 5-category assessment score for each of the categories | at 24 hours | |
| Post installation pain/stinging was assessed using a 5-category intensity score | at 24 hours | |
| Post installation itching was assessed using a 5-category intensity score | at 24 hours | |
| Post installation dryness was assessed using a 5-category intensity score | at 24 hours | |
| Post installation scratchiness was assessed using a 5-category intensity score | at 24 hours | |
| Post installation discomfort preventing sleep was assessed using a 5-category intensity score | at 24 hours | |
| Post installation discomfort upon awakening was assessed using a 5-category intensity score | at 24 hours | |
| Post installation excessive discharge upon awakening was assessed using a 5-category intensity score |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events as a measure of safety and tolerabilitay | 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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| BAY 987516 (Y65-118) |
| Drug |
5 µL in one eye |
|
| Control | Drug | 5 uL in other eye |
|
| at 24 hours |
| Post installation pain in bright sunlight was assessed using a 5-category intensity score | at 24 hours |