Sunscreening Agents
Conditions
Brief summary
Evaluation of the human eye irritation potential of a test sunscreen formulation.
Interventions
DRUGBAY987521
10 micro L of the appropriate test product is place into the lower conjunctival sac of the designated eye (Formulation code: Y49-103).
DRUGControl
10 micro L of the appropriate controlled product is place into the lower conjunctival sac of the designated eye.
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects must be healthy males or females between the ages of 18 to 60 years inclusive. * Subjects do not wear contact lenses or willing to refrain from wearing them during the day of and day after the study. * Subjects are willing to report any medications taken during the study and refrain from taking any medication during the study. * Subjects are willing to have the test materials instilled into the eyes and follow all protocol requirements.
Exclusion criteria
* Subjects have ocular disease or peri-orbital dermatitis or trauma. * Subjects have a systemic illness which contra-indicates participation. * Subjects must not have a history of pre-existing sensitivity or other types of allergy to any eye products. * Subjects must not have a history of allergies or sensitivities to cosmetics, toiletries, dermatological products, or any ingredients contained in the test or control products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Macroscopic evaluations for Lacrimation (score 0-4) | up to 1 hour post instillation |
| Macroscopic evaluations for Bulbar Conjuctiva Irritation (score 0-3) | up to 1 hour post instillation |
| Macroscopic evaluations of Palpebral Conjunctiva Irritation (score 0-3) | up to 1 hour post instillation |
| Subjective assessment of discomfort (score 0-4) | up to 1 hour post instillation |
Countries
United States
Outcome results
None listed