Sunscreening Agents
Conditions
Brief summary
To evaluate the human eye irritation potential of one test sunscreen formulation.
Interventions
OTHERSunscreen 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.
OTHEROphthalmic Ointment
Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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, 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed