Trial Condition(s):

Sunscreening Agents

Evaluation of the Irritation Potential of Products in Human Eyes.

Bayer Identifier:

18598

ClinicalTrials.gov Identifier:

NCT02728856

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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

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.

Trial Summary

Enrollment Goal
48
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
BAY987516
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

St. Petersburg, United States, 33714

Status
Completed
 

Trial Design