Trial Condition(s):
Sunscreen agents
Evaluation of the Stinging Potential of Products in Human Eyes
Bayer Identifier:
17913
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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. The study design was a three cell, single blind study. Subjects were given the industry standard shampoo mixture in one eye and an exploratory sunscreen in the other as according to the randomization schedule.
Inclusion Criteria
: - Male or female subjects, aged 18 to 65 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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| 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 of Products in Human Eyes
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Randomized
Blinding:
Single Blind
Assignment:
Single Group Assignment
Trial Arms:
3
Primary Outcome
- Subjective discomfort in the eye was assessed based on questions by an Ophthalmologist to the subject using a 5-category intensity scaleTimeframe: up to 24 hours after instillation
- Tearing/Lacrimation was assessed by the Ophthalmologist using a 5-category assessment scoreTimeframe: up to 24 hours after instillation
- Objective inflammation was assessed by the Ophthalmologist using a 5-category assessment scoreTimeframe: up to 24 hours after instillation
- Post installation eye effects were assessed using a 5-category intensity scoreTimeframe: up to 24 hours after instillation
Secondary Outcome
- Number of adverse events as a measure of safety and tolerabilityTimeframe: at 24 hours
Additional Information
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