Evaluation of the Stinging Potential in Human Eyes

Sunscreen Agents Clinical Trial

Official title:

Evaluation of the Stinging Potential in Human Eyes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02872207
• Other study ID #: 18196
• Status: Completed
• Phase: N/A
• Start date: February 21, 2015
• Est. completion date: February 22, 2015

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 22, 2015
• Est. primary completion date: February 22, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Male or female subjects, aged 18 to 60 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:
• BAY 987516 (Y65-122)
5 µL in one eye
• BAY 987516 (Y65-118)
5 µL in one eye
• Control
5 uL in other 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, and a 5-category intensity scale.		up to 24 hours
Primary	Tearing/Lacrimation was assessed by the Ophthalmologist using a 5-category assessment score for each of the categories		up to 24 hours
Primary	Objective inflammation was assessed by the Ophthalmologist using a 5-category assessment score for each of the categories		at 24 hours
Primary	Post installation pain/stinging was assessed using a 5-category intensity score		at 24 hours
Primary	Post installation itching was assessed using a 5-category intensity score		at 24 hours
Primary	Post installation dryness was assessed using a 5-category intensity score		at 24 hours
Primary	Post installation scratchiness was assessed using a 5-category intensity score		at 24 hours
Primary	Post installation discomfort preventing sleep was assessed using a 5-category intensity score		at 24 hours
Primary	Post installation discomfort upon awakening was assessed using a 5-category intensity score		at 24 hours
Primary	Post installation excessive discharge upon awakening was assessed using a 5-category intensity score		at 24 hours
Primary	Post installation pain in bright sunlight was assessed using a 5-category intensity score		at 24 hours
Secondary	Number of adverse events as a measure of safety and tolerabilitay		at 24 hours

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