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Evaluation of the Irritation Potential of Products in Human Eyes.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02728856
Recruitment Status : Completed
First Posted : April 5, 2016
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE March 3, 2016
First Posted Date  ICMJE April 5, 2016
Last Update Posted Date March 31, 2017
Actual Study Start Date  ICMJE February 27, 2016
Actual Primary Completion Date February 27, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2016)
  • Subjective assessment of discomfort in the eyes assessed by 5 point scale [ Time Frame: Up to 1 day ]
  • Intensity of Lacrimation assessed by 5 grading scale [ Time Frame: Up to 1 day ]
  • Intensity of Bulbar Conjunctiva Irritation assessed by 4 grading scale [ Time Frame: Up to 1 day ]
  • Intensity of Palpebral Conjunctiva Irritation assessed by 4 grading scale [ Time Frame: Up to 1 day ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Irritation Potential of Products in Human Eyes.
Official Title  ICMJE Evaluation of the Irritation Potential of Products in Human Eyes
Brief Summary To evaluate the human eye irritation potential of two test sunscreen formulation
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Sunscreening Agents
Intervention  ICMJE
  • Other: Sunscreen Spray SPF50 Z15-034(BAY987516)
    Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.
  • Other: Shampoo Control
    Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.
  • Other: Sunscreen Spray SPF50 Z15-038(BAY987516)
    Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.
Study Arms  ICMJE
  • Experimental: Sun Protection Factor (SPF) 50 Z15-034(BAY987516)
    Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.
    Interventions:
    • Other: Sunscreen Spray SPF50 Z15-034(BAY987516)
    • Other: Shampoo Control
  • Experimental: Sunscreen Spray SPF50 Z15-038(BAY987516)
    Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.
    Interventions:
    • Other: Shampoo Control
    • Other: Sunscreen Spray SPF50 Z15-038(BAY987516)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 31, 2016)
48
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 27, 2016
Actual Primary Completion Date February 27, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must be healthy males or females between the ages of 18 to 60 years inclusive with no medical conditions of the eyes.
  • Do not wear contact lenses or, if he/she does wear contact lenses, is willing to refrain from wearing these during the test period.
  • Willing to report any medications taken during the study.
  • Willing to have the test materials instilled into the eyes and follow all protocol requirements.
  • Have been informed and have given written consent to participate in the study.

Exclusion Criteria:

  • Has ocular disease or peri-orbital dermatitis or trauma, infections or chronic eye conditions that may affect the study outcome.
  • Has systemic illness which affects the eyes, including diabetes, thyroid disease, sarcoidosis, hypertension, atherosclerosis, lupus, multiple sclerosis, sickle cell disease, acquired immune deficiency syndrome (AIDs), severer rheumatoid arthritis. results as determined by the investigator.
  • Must not have a history of pre-existing sensitivity or other types of allergy to any eye products.
  • Must not have received and used an Investigational New Drug within the thirty days immediately preceding the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02728856
Other Study ID Numbers  ICMJE 18598
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP