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
65
10 µL in one eye
10 µL in one eye
10 µL in one eye
Unnamed facility
St. Petersburg, Florida, United States
Subjective discomfort in the eye was assessed based on questions by an Ophthalmologist to the subject using a 5-category intensity scale
Time frame: up to 24 hours
Tearing/Lacrimation was assessed by the Ophthalmologist using a 5-category assessment score
Time frame: up to 24 hours
Objective inflammation was assessed by the Ophthalmologist using a 5-category assessment score
Time frame: up to 24 hours
Post installation eye effects were assessed using a 5-category intensity score
Time frame: up to 24 hours
Number of adverse events as a measure of safety and tolerability
Time frame: at 24 hours
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10 µL in other eye