Sunscreen Agents
Conditions
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.
Interventions
DRUGBAY98751 (Y65-110)
10 µL in one eye
DRUGBAY 98751 (Y65-102)
10 µL in one eye
DRUGBAY 98751 (Y65-106)
10 µL in one eye
10 µL in other eye
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| Tearing/Lacrimation was assessed by the Ophthalmologist using a 5-category assessment score | up to 24 hours |
| Objective inflammation was assessed by the Ophthalmologist using a 5-category assessment score | up to 24 hours |
| Post installation eye effects were assessed using a 5-category intensity score | up to 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Number of adverse events as a measure of safety and tolerability | at 24 hours |
Countries
United States
Outcome results
None listed