Evaluation of the Stinging Potential of Products in Human Eyes

Sunscreen Agents Clinical Trial

Official title:

Evaluation of the Stinging Potential of Products in Human Eyes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02872194
• Other study ID #: 17913
• Status: Completed
• Phase: N/A
• Start date: September 5, 2014
• Est. completion date: September 6, 2014

Study information

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

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 6, 2014
• Est. primary completion date: September 6, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Sunscreen Agents

Intervention

Drug:
• BAY987516, Y55-170
10 uL in one eye
• BAY987516, X72-151
10 uL in one eye
• BAY987516, Y49-034
10 uL in one eye
• Standard shampoo mixture (control)
10 uL in one 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	Subjective discomfort in the eye was assessed based on questions by an Ophthalmologist to the subject using a 5-category intensity scale		up to 24 hours after instillation
Primary	Tearing/Lacrimation was assessed by the Ophthalmologist using a 5-category assessment score		up to 24 hours after instillation
Primary	Objective inflammation was assessed by the Ophthalmologist using a 5-category assessment score		up to 24 hours after instillation
Primary	Post installation eye effects were assessed using a 5-category intensity score		up to 24 hours after instillation
Secondary	Number of adverse events as a measure of safety and tolerability		at 24 hours

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