Evaluation of the Irritation Potential of Sunscreen Products in Human Eyes

Sunscreening Agents Clinical Trial

Official title:

Evaluation of the Irritation Potential of Sunscreen Products in Human Eyes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02854137
• Other study ID #: 18434
• Status: Completed
• Phase: N/A
• Start date: October 14, 2015
• Est. completion date: October 14, 2015

Study information

• Verified date: December 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 14, 2015
• Est. primary completion date: October 14, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Sunscreening Agents

Intervention

Drug:
• BAY987521
10 micro L of the appropriate test product is place into the lower conjunctival sac of the designated eye (Formulation code: Y49-103).
• Control
10 micro L of the appropriate controlled product is place into the lower conjunctival sac of the designated eye.

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	Macroscopic evaluations for Lacrimation (score 0-4)		up to 1 hour post instillation
Primary	Macroscopic evaluations for Bulbar Conjuctiva Irritation (score 0-3)		up to 1 hour post instillation
Primary	Macroscopic evaluations of Palpebral Conjunctiva Irritation (score 0-3)		up to 1 hour post instillation
Primary	Subjective assessment of discomfort (score 0-4)		up to 1 hour post instillation

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