To Evaluate Eye Installation-Tear Free

Study Overview
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Brief Summary
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The primary objective of this study was to compare the human eye stinging potential of experimental formulas of sun care products [Sun Protection Factor (SPF) 50 Y49 091, SPF 50 X15 158, SPF 50 X15 160 and SPF 50 X57 162 compared to an industry standard shampoo mixture.

Official Title
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Evaluation of the Stinging Potential of Products in Human Eyes

Conditions
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Sunscreening Agents

Intervention / Treatment
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* Drug: SPF 50 Y49 091 (BAY 987516)
* Drug: SPF 50 X15 158 (BAY 987516)
* Drug: SPF 50 X15 160 (BAY 987516)
* Drug: SPF 50 X57 162 (BAY 987516)
* Other: J & J baby shampoo, X46 046 (control)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males or females, 18 to 60 years with no medical conditions of the eyes as determined by the subject's medical history and confirmed by an ophthalmologist Subjects not under any doctor's care for ocular or peri orbital diseases The subject will refrain from using contact lenses, any topical facial products, any eye drops, false eyelashes, make up, over the counter products, or cosmetics on their eyes, eyelids, eyelashes, or the periorbital areas of the face during the study.

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: SPF 50 Y49 091<br>Subjects were given the control article (standard shampoo mixture, X46 046) in one eye and one of the test articles in the other eye according to the randomization schedule. | Drug: SPF 50 Y49 091 (BAY 987516)<br>* 5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.<br>Other: J & J baby shampoo, X46 046 (control)<br>* 5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.<br>|
| Experimental: SPF 50 X15 158<br>Subjects were given the control article (standard shampoo mixture, X46 046) in one eye and one of the test articles in the other eye according to the randomization schedule. | Drug: SPF 50 X15 158 (BAY 987516)<br>* 5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.<br>Other: J & J baby shampoo, X46 046 (control)<br>* 5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.<br>|
| Experimental: SPF 50 X15 160<br>Subjects were given the control article (standard shampoo mixture, X46 046) in one eye and one of the test articles in the other eye according to the randomization schedule. | Drug: SPF 50 X15 160 (BAY 987516)<br>* 5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.<br>Other: J & J baby shampoo, X46 046 (control)<br>* 5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.<br>|
| Experimental: SPF 50 X57 162<br>Subjects were given the control article (standard shampoo mixture, X46 046) in one eye and one of the test articles in the other eye according to the randomization schedule. | Drug: SPF 50 X57 162 (BAY 987516)<br>* 5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.<br>Other: J & J baby shampoo, X46 046 (control)<br>* 5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective discomfort | Score 0: No discomfort felt Score 1: Faint, barely perceptible discomfort Score 2: Mild, low intensity discomfort that does not prevent the subject from opening lids Score 3: Moderately intense discomfort that interferes with but does not prevent lid opening Score 4: Severe, very intense discomfort that makes voluntary lid opening difficult, requires force to pull lids apart, and results in the subject requesting washout of test article | up to 10 days | 
| Objective lacrimation | Score 0: No tearing or lid wetness above normal Score 1: Noticeable increase in moistness of lid edges - no frank tearing Score 2: Frank tearing - meager flow Score 3: Frank tearing - moderate flow Score 4: Frank tearing - copious flow | up to 10 days | 
| Objective conjunctival inflammation | Score 0: Inflammatory changes absent Score 1: Capillaries slightly more prominent than they were at time of baseline examination Score 2: Capillaries very prominent plus some diffuse conjunctival reddening Score 3: Vessels very prominent plus diffuse and confluent intense redness Score 4: Beefy redness and everted lids | up to 10 days | 
| Objective cornea and iris inflammation | Score 0: No effect detected with use of slit lamp Score 1: Barely perceptible clouding or pitting of cornea or thickening of iris detected via slit lamp Score 2: Faint clouding or pitting of cornea and/or thickening of the iris Score 3: Moderate clouding or pitting of cornea and/or thickening of the iris Score 4: Intense clouding or pitting of cornea and/or thickening of the iris | up to 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eye stinging potential