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Evaluation of the Stinging Potential of Products in Human Eyes

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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

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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