- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02872207
Evaluation of the Stinging Potential in Human Eyes
December 11, 2018 updated by: Bayer
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Saint Petersburg, Florida, United States, 33714
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Suncare agent 1 + control
Application of control and test product into one of the subjects two eyes.
|
5 µL in one eye
5 uL in other eye
|
Experimental: Suncare agent 2 + control
Application of control and test product into one of the subjects two eyes.
|
5 uL in other eye
5 µL in one eye
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
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
|
at 24 hours
|
Post installation pain/stinging was assessed using a 5-category intensity score
Time Frame: at 24 hours
|
at 24 hours
|
Post installation itching was assessed using a 5-category intensity score
Time Frame: at 24 hours
|
at 24 hours
|
Post installation dryness was assessed using a 5-category intensity score
Time Frame: at 24 hours
|
at 24 hours
|
Post installation scratchiness was assessed using a 5-category intensity score
Time Frame: at 24 hours
|
at 24 hours
|
Post installation discomfort preventing sleep was assessed using a 5-category intensity score
Time Frame: at 24 hours
|
at 24 hours
|
Post installation discomfort upon awakening was assessed using a 5-category intensity score
Time Frame: at 24 hours
|
at 24 hours
|
Post installation excessive discharge upon awakening was assessed using a 5-category intensity score
Time Frame: at 24 hours
|
at 24 hours
|
Post installation pain in bright sunlight was assessed using a 5-category intensity score
Time Frame: at 24 hours
|
at 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of adverse events as a measure of safety and tolerabilitay
Time Frame: at 24 hours
|
at 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 21, 2015
Primary Completion (Actual)
February 22, 2015
Study Completion (Actual)
February 22, 2015
Study Registration Dates
First Submitted
August 5, 2016
First Submitted That Met QC Criteria
August 17, 2016
First Posted (Estimate)
August 19, 2016
Study Record Updates
Last Update Posted (Actual)
December 12, 2018
Last Update Submitted That Met QC Criteria
December 11, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 18196
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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