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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
40
Unnamed facility
St. Petersburg, Florida, United States
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
Tearing/Lacrimation was assessed by the Ophthalmologist using a 5-category assessment score for each of the categories
Time frame: up to 24 hours
Objective inflammation was assessed by the Ophthalmologist using a 5-category assessment score for each of the categories
Time frame: at 24 hours
Post installation pain/stinging was assessed using a 5-category intensity score
Time frame: at 24 hours
Post installation itching was assessed using a 5-category intensity score
Time frame: at 24 hours
Post installation dryness was assessed using a 5-category intensity score
Time frame: at 24 hours
Post installation scratchiness was assessed using a 5-category intensity score
Time frame: at 24 hours
Post installation discomfort preventing sleep was assessed using a 5-category intensity score
Time frame: at 24 hours
Post installation discomfort upon awakening was assessed using a 5-category intensity score
Time frame: at 24 hours
Post installation excessive discharge upon awakening was assessed using a 5-category intensity score
Time frame: at 24 hours
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Post installation pain in bright sunlight was assessed using a 5-category intensity score
Time frame: at 24 hours
Number of adverse events as a measure of safety and tolerabilitay
Time frame: at 24 hours