To Evaluate Eye Installation-Tear Free

Not Applicable

Completed

• Conditions: Sunscreening Agents
• Interventions: Drug: SPF 50 X15 158 (BAY 987516); Drug: SPF 50 X57 162 (BAY 987516); Drug: SPF 50 Y49 091 (BAY 987516); Drug: SPF 50 X15 160 (BAY 987516); Other: J & J baby shampoo, X46 046 (control)

• Registration Number: NCT02802917
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-15
• Primary Completion: 2015-05-24
• Study Completion: 2015-05-24
• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-16
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-11
• Last Update Posted: 2018-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPF 50 X15 158	SPF 50 X15 158 (BAY 987516)	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.
SPF 50 Y49 091	J & J baby shampoo, X46 046 (control)	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.
SPF 50 X57 162	SPF 50 X57 162 (BAY 987516)	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.
SPF 50 X15 158	J & J baby shampoo, X46 046 (control)	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.
SPF 50 X57 162	J & J baby shampoo, X46 046 (control)	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.
SPF 50 Y49 091	SPF 50 Y49 091 (BAY 987516)	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.
SPF 50 X15 160	SPF 50 X15 160 (BAY 987516)	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.
SPF 50 X15 160	J & J baby shampoo, X46 046 (control)	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.

Primary Outcome Measures

Name	Time	Method
Subjective discomfort	up to 10 days	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
Objective lacrimation	up to 10 days	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
Objective conjunctival inflammation	up to 10 days	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
Objective cornea and iris inflammation	up to 10 days	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