Evaluation of the Irritation Potential of Sunscreen Products in Human Eyes

Evaluation of the human eye irritation potential of a test sunscreen formulation.

Study Overview

• Status: Completed
• Conditions: Sunscreening Agents
• Intervention / Treatment: Drug: BAY987521; Drug: Control

• Study Type: Interventional
• Enrollment (Actual): 23
• 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:

• Subjects must be healthy males or females between the ages of 18 to 60 years inclusive.
• Subjects do not wear contact lenses or willing to refrain from wearing them during the day of and day after the study.
• Subjects are willing to report any medications taken during the study and refrain from taking any medication during the study.
• Subjects are willing to have the test materials instilled into the eyes and follow all protocol requirements.

Exclusion Criteria:

• Subjects have ocular disease or peri-orbital dermatitis or trauma.
• Subjects have a systemic illness which contra-indicates participation.
• Subjects must not have a history of pre-existing sensitivity or other types of allergy to any eye products.
• Subjects must not have a history of allergies or sensitivities to cosmetics, toiletries, dermatological products, or any ingredients contained in the test or control products.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sunscreen / Arm 1; Subjects will be escorted to a separate room for instillation of the test materials. Test materials will be instilled in immediate succession and with a randomized order of presentation. A trained technician will use the thumb and forefinger of one hand to retract the lower eyelid from the eyes of the subject forming sacs in the conjuntival tissue, apply one test product to one eye.	Drug: BAY987521; 10 micro L of the appropriate test product is place into the lower conjunctival sac of the designated eye (Formulation code: Y49-103).
Other: Control; A trained technician will use the thumb and forefinger of one hand to retract the lower eyelid from the other eyes of the subject forming sacs in the conjuntival tissue, apply control materials to this eye, follow the same procedure, using a new pipet tip or steriled dropper.	Drug: Control; 10 micro L of the appropriate controlled product is place into the lower conjunctival sac of the designated eye.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Macroscopic evaluations for Lacrimation (score 0-4)	up to 1 hour post instillation
Macroscopic evaluations for Bulbar Conjuctiva Irritation (score 0-3)	up to 1 hour post instillation
Macroscopic evaluations of Palpebral Conjunctiva Irritation (score 0-3)	up to 1 hour post instillation
Subjective assessment of discomfort (score 0-4)	up to 1 hour post instillation

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2015
• Primary Completion (Actual): October 14, 2015
• Study Completion (Actual): October 14, 2015

Study Registration Dates

• First Submitted: July 29, 2016
• First Submitted That Met QC Criteria: July 29, 2016
• First Posted (Estimate): August 3, 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: 18434

Drug and device information, study documents

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