Trial Condition(s):
Sunscreen agents
Evaluation of the Stinging Potential in Human Eyes
Bayer Identifier:
18196
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
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.
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
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
40
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
BAY987516
Accepts Healthy Volunteers
Yes
Where to Participate
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Locations
Status
| Locations | Status | |
|---|---|---|
Locations Investigative Site St. Petersburg, United States, 33714 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
2
Primary Outcome
- 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
- Tearing/Lacrimation was assessed by the Ophthalmologist using a 5-category assessment score for each of the categoriesTimeframe: up to 24 hours
- Objective inflammation was assessed by the Ophthalmologist using a 5-category assessment score for each of the categoriesTimeframe: at 24 hours
- Post installation pain/stinging was assessed using a 5-category intensity scoreTimeframe: at 24 hours
- Post installation itching was assessed using a 5-category intensity scoreTimeframe: at 24 hours
- Post installation dryness was assessed using a 5-category intensity scoreTimeframe: at 24 hours
- Post installation scratchiness was assessed using a 5-category intensity scoreTimeframe: at 24 hours
- Post installation discomfort preventing sleep was assessed using a 5-category intensity scoreTimeframe: at 24 hours
- Post installation discomfort upon awakening was assessed using a 5-category intensity scoreTimeframe: at 24 hours
- Post installation excessive discharge upon awakening was assessed using a 5-category intensity scoreTimeframe: at 24 hours
- Post installation pain in bright sunlight was assessed using a 5-category intensity scoreTimeframe: at 24 hours
Secondary Outcome
- Number of adverse events as a measure of safety and tolerabilitayTimeframe: at 24 hours
Additional Information
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