Evaluation of the Stinging Potential in Human Eyes

Not Applicable

Completed

• Conditions: Sunscreen Agents
• Interventions: Drug: BAY 987516 (Y65-122); Drug: BAY 987516 (Y65-118); Drug: Control

• Registration Number: NCT02872207
• 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-21
• Primary Completion: 2015-02-22
• Study Completion: 2015-02-22
• Study First Submitted: 2016-08-05
• 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: 40

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

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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
Suncare agent 1 + control	BAY 987516 (Y65-122)	Application of control and test product into one of the subjects two eyes.
Suncare agent 1 + control	Control	Application of control and test product into one of the subjects two eyes.
Suncare agent 2 + control	BAY 987516 (Y65-118)	Application of control and test product into one of the subjects two eyes.
Suncare agent 2 + control	Control	Application of control and test product into one of the subjects two eyes.

Primary Outcome Measures

Name	Time	Method
Post installation discomfort upon awakening was assessed using a 5-category intensity score	at 24 hours
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 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

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