Evaluation of the Stinging Potential of Sunscreen Products in Human Eyes

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.

Study Overview

• Status: Completed
• Conditions: Sunscreen Agents
• Intervention / Treatment: Drug: BAY98751 (Y65-110); Drug: Standard shampoo mixture (Control); Drug: BAY 98751 (Y65-102); Drug: BAY 98751 (Y65-106)

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Saint Petersburg, Florida, United States, 33714

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sunscreen agent A + control; Application of control and test product into one of the subjects two eyes.	Drug: BAY98751 (Y65-110); 10 µL in one eye; Drug: Standard shampoo mixture (Control); 10 µL in other eye
Experimental: Sunscreen agent B + control; Application of control and test product into one of the subjects two eyes.	Drug: Standard shampoo mixture (Control); 10 µL in other eye; Drug: BAY 98751 (Y65-102); 10 µL in one eye
Experimental: Sunscreen agent C + control; Application of control and test product into one of the subjects two eyes.	Drug: Standard shampoo mixture (Control); 10 µL in other eye; Drug: BAY 98751 (Y65-106); 10 µL in one eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Tearing/Lacrimation was assessed by the Ophthalmologist using a 5-category assessment score	up to 24 hours
Objective inflammation was assessed by the Ophthalmologist using a 5-category assessment score	up to 24 hours
Post installation eye effects were assessed using a 5-category intensity score	up to 24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of adverse events as a measure of safety and tolerability	at 24 hours

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2015
• Primary Completion (Actual): January 24, 2015
• Study Completion (Actual): January 24, 2015

Study Registration Dates

• First Submitted: August 3, 2016
• First Submitted That Met QC Criteria: August 12, 2016
• First Posted (Estimate): August 16, 2016

Study Record Updates

• Last Update Posted (Actual): December 12, 2018
• Last Update Submitted That Met QC Criteria: December 11, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 18067

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No