Evaluation of the Irritation Potential of Products in Human Eyes.

Sunscreening Agents Clinical Trial

Official title:

Evaluation of the Irritation Potential of Products in Human Eyes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02728856
• Other study ID #: 18598
• Status: Completed
• Phase: N/A
• First received: March 3, 2016
• Last updated: March 30, 2017
• Start date: February 27, 2016
• Est. completion date: February 27, 2016

Study information

• Verified date: March 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the human eye irritation potential of two test sunscreen formulation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 27, 2016
• Est. primary completion date: February 27, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sunscreening Agents

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective assessment of discomfort in the eyes assessed by 5 point scale		Up to 1 day
Primary	Intensity of Lacrimation assessed by 5 grading scale		Up to 1 day
Primary	Intensity of Bulbar Conjunctiva Irritation assessed by 4 grading scale		Up to 1 day
Primary	Intensity of Palpebral Conjunctiva Irritation assessed by 4 grading scale		Up to 1 day

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