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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02714166
Other study ID # 18766
Secondary ID
Status Completed
Phase N/A
First received March 4, 2016
Last updated March 29, 2017
Start date February 26, 2016
Est. completion date February 26, 2016

Study information

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

Clinical Trial Summary

To evaluate the human eye irritation potential of one test sunscreen formulation.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date February 26, 2016
Est. primary completion date February 26, 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, AIDs (Acquired Immune Deficiency Syndrome), 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Sunscreen lotion SPF (Sun Protection Factor) 50 (BAY987521)
Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.
Ophthalmic Ointment
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
See also
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Completed NCT02936570 - Sun Protection Factor Assay (SPF Assay 206/2016) N/A
Completed NCT05085327 - Clinical Study to Evaluate the Sun Protection Factor (SPF) of Sunscreen Products N/A
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Completed NCT02854137 - Evaluation of the Irritation Potential of Sunscreen Products in Human Eyes N/A
Completed NCT02930746 - Sun Protection Factor Assay (SPF Assay 199/2016) N/A
Completed NCT02930772 - Sun Protection Factor Assay (SPF Assay 201/2016) N/A
Completed NCT02930759 - Sun Protection Factor Assay (SPF Assay 200/2016) N/A
Completed NCT02930785 - Sun Protection Factor Assay (SPF Assay 202/2016) N/A
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