Study Completed

Sunscreen agents

Bayer Identifier:

18196

ClinicalTrials.gov Identifier:

NCT02872207

EudraCT Number:

Not Available

EU CT Number:

Not Available

Evaluation of the Stinging Potential in Human Eyes

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - 60 Years

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
Exclusion Criteria

Trial summary

Enrollment Goal

Trial Dates

February 2015 - February 2015

Phase

N/A

Could I Receive a placebo

Products

BAY987516

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed		St. Petersburg, 33714, United States

Primary Outcome

Subjective discomfort in the eye was assessed based on questions by an Ophthalmologist to the subject, and a 5-category intensity scale.
Time Frame:
up to 24 hours
Safety Issue:
No
Tearing/Lacrimation was assessed by the Ophthalmologist using a 5-category assessment score for each of the categories
Time Frame:
up to 24 hours
Safety Issue:
No
Objective inflammation was assessed by the Ophthalmologist using a 5-category assessment score for each of the categories
Time Frame:
at 24 hours
Safety Issue:
No
Post installation pain/stinging was assessed using a 5-category intensity score
Time Frame:
at 24 hours
Safety Issue:
No
Post installation itching was assessed using a 5-category intensity score
Time Frame:
at 24 hours
Safety Issue:
No
Post installation dryness was assessed using a 5-category intensity score
Time Frame:
at 24 hours
Safety Issue:
No
Post installation scratchiness was assessed using a 5-category intensity score
Time Frame:
at 24 hours
Safety Issue:
No
Post installation discomfort preventing sleep was assessed using a 5-category intensity score
Time Frame:
at 24 hours
Safety Issue:
No
Post installation discomfort upon awakening was assessed using a 5-category intensity score
Time Frame:
at 24 hours
Safety Issue:
No
Post installation excessive discharge upon awakening was assessed using a 5-category intensity score
Time Frame:
at 24 hours
Safety Issue:
No
Post installation pain in bright sunlight was assessed using a 5-category intensity score
Time Frame:
at 24 hours
Safety Issue:
No

Secondary Outcome

Number of adverse events as a measure of safety and tolerabilitay
Time Frame:
at 24 hours
Safety Issue:
Yes

Trial design

Evaluation of the Stinging Potential in Human Eyes

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Other

Allocation

Randomized

Blinding

Single Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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