Evaluation of the Irritation Potential of Products in Human Eyes

NCT ID: NCT02714166

Last Updated: 2017-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-26
• Study Completion Date: 2016-02-26

Brief Summary

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

Conditions

Sunscreening Agents

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Sunscreen lotion 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.

Group Type: EXPERIMENTAL

Sunscreen lotion SPF (Sun Protection Factor) 50 (BAY987521)

Intervention Type: OTHER

Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.

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.

Group Type: OTHER

Ophthalmic Ointment

Intervention Type: OTHER

Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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, 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

St. Petersburg, Florida, United States

Countries

United States

Other Identifiers

18766

Identifier Type: -

Identifier Source: org_study_id