check_circleStudy Completed

Sunscreening agents

Bayer Identifier:

18434

ClinicalTrials.gov Identifier:

NCT02854137

EudraCT Number:

Not Available

EU CT Number:

Not Available
Evaluation of the Irritation Potential of Sunscreen Products in Human Eyes

Trial purpose

Evaluation of the human eye irritation potential of a test sunscreen formulation.

Key Participants Requirements

Sex

Both

Age

18 - 60 Years
  • - Subjects must be healthy males or females between the ages of 18 to 60 years inclusive.
    - Subjects do not wear contact lenses or willing to refrain from wearing them during the day of and day after the study.
    - Subjects are willing to report any medications taken during the study and refrain from taking any medication during the study.
    - Subjects are willing to have the test materials instilled into the eyes and follow all protocol requirements.


  • - Subjects have ocular disease or peri-orbital dermatitis or trauma.
    - Subjects have a systemic illness which contra-indicates participation.
    - Subjects must not have a history of pre-existing sensitivity or other types of allergy to any eye products.
    - Subjects must not have a history of allergies or sensitivities to cosmetics, toiletries, dermatological products, or any ingredients contained in the test or control products.

Trial summary

Enrollment Goal
23
Trial Dates
October 2015 - October 2015
Phase
N/A
Could I Receive a placebo
No
Products
BAY987521
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
St. Petersburg, 33714, United States

Primary Outcome

  • Macroscopic evaluations for Lacrimation (score 0-4)
    date_rangeTime Frame:
    up to 1 hour post instillation
    enhanced_encryption
    Safety Issue:
    Yes
  • Macroscopic evaluations for Bulbar Conjuctiva Irritation (score 0-3)
    date_rangeTime Frame:
    up to 1 hour post instillation
    enhanced_encryption
    Safety Issue:
    Yes
  • Macroscopic evaluations of Palpebral Conjunctiva Irritation (score 0-3)
    date_rangeTime Frame:
    up to 1 hour post instillation
    enhanced_encryption
    Safety Issue:
    Yes
  • Subjective assessment of discomfort (score 0-4)
    date_rangeTime Frame:
    up to 1 hour post instillation
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Evaluation of the Irritation Potential of Sunscreen Products in Human Eyes
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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