Evaluation of the Irritation Potential of Sunscreen Products in Human Eyes

Not Applicable

Completed

• Conditions: Sunscreening Agents
• Interventions: Drug: Control; Drug: BAY987521

• Registration Number: NCT02854137
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-14
• Primary Completion: 2015-10-14
• Study Completion: 2015-10-14
• Study First Submitted: 2016-07-29
• Study First Submitted QC: 2016-07-29
• Study First Posted: 2016-08-03
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-11
• Last Update Posted: 2018-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	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.
Sunscreen / Arm 1	BAY987521	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.

Primary Outcome Measures

Name	Time	Method
Macroscopic evaluations for Lacrimation (score 0-4)	up to 1 hour post instillation
Subjective assessment of discomfort (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