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Evaluation of the Irritation Potential of Products in Human Eyes. | Clinical Trials | Clareo Health

COMPLETEDNA

Evaluation of the Irritation Potential of Products in Human Eyes.

Evaluation of the Irritation Potential of Products in Human Eyes

NCT02728856•Bayer

View on ClinicalTrials.gov

Summary

To evaluate the human eye irritation potential of two test sunscreen formulation

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Yes

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.

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, acquired immune deficiency syndrome (AIDs), 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.

Locations (1)

St. Petersburg, Florida, United States

Key Dates

Start Date

February 27, 2016

Primary Completion Date

February 27, 2016

Completion Date

February 27, 2016

Last Updated

March 31, 2017

Enrollment

ACTUAL participants

Conditions

Sunscreening Agents

Interventions

Sunscreen Spray SPF50 Z15-034(BAY987516)

OTHER

Shampoo Control

OTHER

Sunscreen Spray SPF50 Z15-038(BAY987516)

OTHER

Bemotrizinol UV Filter Part 1 Clinical PK Evaluation in Topical MUsT Study

NCT04355286

Absorption; ChemicalsSunscreening Agents

View study

COMPLETEDNA

Human Phototoxicity Test

NCT02750475

Sunscreening Agents

View study

COMPLETEDNA

Sun Protection Factor Assay

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 31, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of the Irritation Potential of Products in Human Eyes.

Inclusion Criteria

Exclusion Criteria

Bemotrizinol UV Filter Part 1 Clinical PK Evaluation in Topical MUsT Study

Human Phototoxicity Test

Sun Protection Factor Assay

Sun Protection Factor Assay (SPF Assay 200/2016)

Human Phototoxicity Test (823/2016)

Human Photoallergy Test (824/2016)