check_circleStudy Completed

Sunscreen agents

Bayer Identifier:

17913

ClinicalTrials.gov Identifier:

NCT02872194

EudraCT Number:

Not Available

EU CT Number:

Not Available
Evaluation of the Stinging Potential of Products in Human Eyes

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.

Key Participants Requirements

Sex

Both

Age

18 - 65 Years
  • - 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

Trial summary

Enrollment Goal
21
Trial Dates
September 2014 - September 2014
Phase
N/A
Could I Receive a placebo
No
Products
BAY987516
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
St. Petersburg, 33714, United States

Primary Outcome

  • Subjective discomfort in the eye was assessed based on questions by an Ophthalmologist to the subject using a 5-category intensity scale
    date_rangeTime Frame:
    up to 24 hours after instillation
    enhanced_encryption
    Safety Issue:
    No
  • Tearing/Lacrimation was assessed by the Ophthalmologist using a 5-category assessment score
    date_rangeTime Frame:
    up to 24 hours after instillation
    enhanced_encryption
    Safety Issue:
    No
  • Objective inflammation was assessed by the Ophthalmologist using a 5-category assessment score
    date_rangeTime Frame:
    up to 24 hours after instillation
    enhanced_encryption
    Safety Issue:
    No
  • Post installation eye effects were assessed using a 5-category intensity score
    date_rangeTime Frame:
    up to 24 hours after instillation
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    at 24 hours
    enhanced_encryption
    Safety Issue:
    Yes

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

Additional Information

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