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Evaluation of the Irritation Potential of Products in Human Eyes.

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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

Study Description
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Brief Summary:
To evaluate the human eye irritation potential of two test sunscreen formulation

Condition or disease Intervention/treatment Phase
Sunscreening Agents Other: Sunscreen Spray SPF50 Z15-034(BAY987516) Other: Shampoo Control Other: Sunscreen Spray SPF50 Z15-038(BAY987516) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Evaluation of the Irritation Potential of Products in Human Eyes
Actual Study Start Date : February 27, 2016
Actual Primary Completion Date : February 27, 2016
Actual Study Completion Date : February 27, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sun Exposure

Arms and Interventions
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Arm Intervention/treatment
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.
 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.
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Subjective assessment of discomfort in the eyes assessed by 5 point scale [ Time Frame: Up to 1 day ]
  2. Intensity of Lacrimation assessed by 5 grading scale [ Time Frame: Up to 1 day ]
  3. Intensity of Bulbar Conjunctiva Irritation assessed by 4 grading scale [ Time Frame: Up to 1 day ]
  4. Intensity of Palpebral Conjunctiva Irritation assessed by 4 grading scale [ Time Frame: Up to 1 day ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728856


Locations
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United States, Florida
St. Petersburg, Florida, United States, 33714
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Additional Information:

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02728856    
Other Study ID Numbers: 18598
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Dermatologic Agents