Evaluation of the Irritation Potential of Sunscreen Products in Human Eyes

Bayer

Status: Completed

Conditions: Sunscreening Agents

Treatments: Drug: Control; Drug: BAY987521

Study type: Interventional

Funder types: Industry

Identifiers

NCT02854137

18434

Details and patient eligibility

About

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

Enrollment: 23 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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23 participants in 2 patient groups

Sunscreen / Arm 1

Experimental group

Description:

Subjects will be escorted to a separate room for instillation of the test materials. Test materials will be instilled in immediate succession and with a randomized order of presentation. A trained technician will use the thumb and forefinger of one hand to retract the lower eyelid from the eyes of the subject forming sacs in the conjuntival tissue, apply one test product to one eye.

Treatment:

Drug: BAY987521

Control

Other group

Description:

A trained technician will use the thumb and forefinger of one hand to retract the lower eyelid from the other eyes of the subject forming sacs in the conjuntival tissue, apply control materials to this eye, follow the same procedure, using a new pipet tip or steriled dropper.

Treatment:

Drug: Control