Evaluation of the Irritation Potential of Products in Human Eyes

Not Applicable

Completed

• Conditions: Sunscreening Agents
• Interventions: Other: Ophthalmic Ointment; Other: Sunscreen lotion SPF (Sun Protection Factor) 50 (BAY987521)

• Registration Number: NCT02714166
• Lead Sponsor: Bayer

Brief Summary

To evaluate the human eye irritation potential of one test sunscreen formulation.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-26
• Primary Completion: 2016-02-26
• Study Completion: 2016-02-26
• Study First Submitted: 2016-03-04
• Study First Submitted QC: 2016-03-16
• Study First Posted: 2016-03-21
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-29
• Last Update Posted: 2017-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Must be healthy males or females between the ages of 18 to 60 years inclusive with no medical conditions of the eyes.
• Do not wear contact lenses or, if he/she does wear contact lenses, is willing to refrain from wearing these during the test period.
• Willing to report any medications taken during the study.
• Willing to have the test materials instilled into the eyes and follow all protocol requirements.
• Have been informed and have given written consent to participate in the study.

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Exclusion Criteria

• Has ocular disease or peri-orbital dermatitis or trauma, infections or chronic eye conditions that may affect the study outcome.
• Has systemic illness which affects the eyes, including diabetes, thyroid disease, sarcoidosis, hypertension, atherosclerosis, lupus, multiple sclerosis, sickle cell disease, AIDs (Acquired Immune Deficiency Syndrome), severer rheumatoid arthritis. results as determined by the investigator.
• Must not have a history of pre-existing sensitivity or other types of allergy to any eye products.
• Must not have received and used an Investigational New Drug within the thirty days immediately preceding the study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ophthalmic Ointment	Ophthalmic Ointment	Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.
Sunscreen lotion Sun Protection Factor 50 (BAY987521)	Sunscreen lotion SPF (Sun Protection Factor) 50 (BAY987521)	Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.

Primary Outcome Measures

Name	Time	Method
Intensity of Palpebral Conjunctiva Irritation assessed by 4 grading scale.	Up to 1 day
Subjective assessment of discomfort in the eyes assessed by 5 point scale.	Up to 1 day
Intensity of Lacrimation assessed by 5 grading scale.	Up to 1 day
Intensity of Bulbar Conjunctiva Irritation assessed by 4 grading scale.	Up to 1 day