Clinical trial NCT02872207: Evaluation of the Stinging Potential in Human Eyes
Official title: Evaluation of the Stinging Potential in Human Eyes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreen Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-08-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Subjective discomfort in the eye was assessed based on questions by an Ophthalmologist to the subject, and a 5-category intensity scale.
timeFrame: up to 24 hours
measure: Tearing/Lacrimation was assessed by the Ophthalmologist using a 5-category assessment score for each of the categories
timeFrame: up to 24 hours
measure: Objective inflammation was assessed by the Ophthalmologist using a 5-category assessment score for each of the categories
timeFrame: at 24 hours
measure: Post installation pain/stinging was assessed using a 5-category intensity score
timeFrame: at 24 hours
measure: Post installation itching was assessed using a 5-category intensity score
timeFrame: at 24 hours
measure: Post installation dryness was assessed using a 5-category intensity score
timeFrame: at 24 hours
measure: Post installation scratchiness was assessed using a 5-category intensity score
timeFrame: at 24 hours
measure: Post installation discomfort preventing sleep was assessed using a 5-category intensity score
timeFrame: at 24 hours
measure: Post installation discomfort upon awakening was assessed using a 5-category intensity score
timeFrame: at 24 hours
measure: Post installation excessive discharge upon awakening was assessed using a 5-category intensity score
timeFrame: at 24 hours
measure: Post installation pain in bright sunlight was assessed using a 5-category intensity score
timeFrame: at 24 hours
Secondary outcomes:
measure: Number of adverse events as a measure of safety and tolerabilitay
timeFrame: at 24 hours
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
state: Florida
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: