Evaluation of the Stinging Potential of Products in Human Eyes

Not Applicable

Completed

• Conditions: Sunscreen Agents
• Interventions: Drug: BAY987516, Y55-170; Drug: BAY987516, X72-151; Drug: BAY987516, Y49-034; Drug: Standard shampoo mixture (control)

• Registration Number: NCT02872194
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-05
• Primary Completion: 2014-09-06
• Study Completion: 2014-09-06
• Study First Submitted: 2016-08-03
• Study First Submitted QC: 2016-08-17
• Study First Posted: 2016-08-19
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-11
• Last Update Posted: 2018-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Male or female subjects, aged 18 to 65 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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Suncare agent A + control	BAY987516, Y55-170	Application of control and test product into one of the subjects two eyes.
Suncare agent A + control	Standard shampoo mixture (control)	Application of control and test product into one of the subjects two eyes.
Suncare agent B + control	BAY987516, X72-151	Application of control and test product into one of the subjects two eyes.
Suncare agent C + control	BAY987516, Y49-034	Application of control and test product into one of the subjects two eyes.
Suncare agent C + control	Standard shampoo mixture (control)	Application of control and test product into one of the subjects two eyes.
Suncare agent B + control	Standard shampoo mixture (control)	Application of control and test product into one of the subjects two eyes.

Primary Outcome Measures

Name	Time	Method
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
Objective inflammation was assessed by the Ophthalmologist using a 5-category assessment score	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
Post installation eye effects were assessed using a 5-category intensity score	up to 24 hours after instillation

Secondary Outcome Measures

Name	Time	Method
Number of adverse events as a measure of safety and tolerability	at 24 hours