Evaluation of the Stinging Potential of Products in Human Eyes

Bayer

Status: Completed

Conditions: Sunscreen Agents

Treatments: Drug: BAY987516, X72-151; Drug: BAY987516, Y55-170; Drug: BAY987516, Y49-034; Drug: Standard shampoo mixture (control)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02872194

17913

Details and patient eligibility

About

The objective of this study was to compare the human eye stinging potential of experimental formulas and an industry standard shampoo mixture. The study was conducted under the supervision of a Board Certified Ophthalmologist. The study design was a three cell, single blind study. Subjects were given the industry standard shampoo mixture in one eye and an exploratory sunscreen in the other as according to the randomization schedule.

Enrollment: 21 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Male or female subjects, aged 18 to 65 years
• No medical conditions of the eyes as determined by the subjects' medical history and confirmed by ophthalmologist
• Subjects do not wear contact lenses or, if he/she does wear contact lenses, is willing to refrain from wearing these during the day of and day after the study
• Subject is willing to have the test materials instilled into the eyes and follow all protocol requirements
• Subject is willing to refrain from using false eyelashes of any type or any topical prescription, OTC or cosmetic products on their eyes, eyelids, eyelashes or the peri-orbital areas of the face on the day of the study.
• Subjects should refrain from use of make-up on testing day

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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21 participants in 3 patient groups

Suncare agent A + control

Experimental group

Description:

Application of control and test product into one of the subjects two eyes.

Treatment:

Drug: Standard shampoo mixture (control)

Drug: BAY987516, Y55-170

Suncare agent B + control

Experimental group

Description:

Application of control and test product into one of the subjects two eyes.

Treatment:

Drug: BAY987516, X72-151

Drug: Standard shampoo mixture (control)

Suncare agent C + control

Experimental group

Description:

Application of control and test product into one of the subjects two eyes.

Treatment:

Drug: Standard shampoo mixture (control)

Drug: BAY987516, Y49-034