Evaluation of the Irritation Potential of Products in Human Eyes

Bayer

Status

Completed

Conditions

Sunscreening Agents

Treatments

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

Other: Ophthalmic Ointment

Study type

Interventional

Funder types

Industry

Identifiers

18766

Details and patient eligibility

About

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

Enrollment

24 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.