Evaluation of the Stinging Potential in Human Eyes

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Stinging Potential in Human Eyes

Conditions
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Sunscreen Agents

Intervention / Treatment
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* Drug: BAY 987516 (Y65-122)
* Drug: BAY 987516 (Y65-118)
* Drug: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects, aged 18 to 60 years No medical conditions of the eyes as determined by the subjects' medical history and confirmed by ophthalmologist Subjects do not wear contact lenses or, if he/she does wear contact lenses, is willing to refrain from wearing these during the day of and day after the study Subject is willing to have the test materials instilled into the eyes and follow all protocol requirements Subject is willing to refrain from using false eyelashes of any type or any topical prescription, OTC or cosmetic products on their eyes, eyelids, eyelashes or the peri-orbital areas of the face on the day of the study. Subjects should refrain from use of make-up on testing day

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suncare agent 1 + control<br>Application of control and test product into one of the subjects two eyes. | Drug: BAY 987516 (Y65-122)<br>* 5 µL in one eye<br>Drug: Control<br>* 5 uL in other eye<br>|
| Experimental: Suncare agent 2 + control<br>Application of control and test product into one of the subjects two eyes. | Drug: BAY 987516 (Y65-118)<br>* 5 µL in one eye<br>Drug: Control<br>* 5 uL in other eye<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |  | at 24 hours | 
| Post installation pain in bright sunlight was assessed using a 5-category intensity score |  | at 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events as a measure of safety and tolerabilitay |  | at 24 hours |