Study Completed

Sunscreening agents

Bayer Identifier:

18434

ClinicalTrials.gov Identifier:

NCT02854137

EudraCT Number:

Not Available

EU CT Number:

Not Available

Evaluation of the Irritation Potential of Sunscreen Products in Human Eyes

Trial purpose

Evaluation of the human eye irritation potential of a test sunscreen formulation.

Key Participants Requirements

Sex

Both

Age

18 - 60 Years

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.

Trial summary

Enrollment Goal

Trial Dates

October 2015 - October 2015

Phase

N/A

Could I Receive a placebo

Products

BAY987521

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed		St. Petersburg, 33714, United States

Primary Outcome

Macroscopic evaluations for Lacrimation (score 0-4)
Time Frame:
up to 1 hour post instillation
Safety Issue:
Yes
Macroscopic evaluations for Bulbar Conjuctiva Irritation (score 0-3)
Time Frame:
up to 1 hour post instillation
Safety Issue:
Yes
Macroscopic evaluations of Palpebral Conjunctiva Irritation (score 0-3)
Time Frame:
up to 1 hour post instillation
Safety Issue:
Yes
Subjective assessment of discomfort (score 0-4)
Time Frame:
up to 1 hour post instillation
Safety Issue:
Yes

Trial design

Evaluation of the Irritation Potential of Sunscreen Products in Human Eyes

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Other

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.