Study Completed

Sunscreening Agents

Bayer Identifier:

18766

ClinicalTrials.gov Identifier:

NCT02714166

EudraCT Number:

Not Available

EU CT Number:

Not Available

Evaluation of the Irritation Potential of Products in Human Eyes

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 - 60 Years

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.

Trial summary

Enrollment Goal

Trial Dates

February 2016 - February 2016

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

Subjective assessment of discomfort in the eyes assessed by 5 point scale.
Time Frame:
Up to 1 day
Safety Issue:
Yes
Intensity of Lacrimation assessed by 5 grading scale.
Time Frame:
Up to 1 day
Safety Issue:
Yes
Intensity of Bulbar Conjunctiva Irritation assessed by 4 grading scale.
Time Frame:
Up to 1 day
Safety Issue:
Yes
Intensity of Palpebral Conjunctiva Irritation assessed by 4 grading scale.
Time Frame:
Up to 1 day
Safety Issue:
Yes

Trial design

Evaluation of the Irritation Potential of Products in Human Eyes

Trial Type

Interventional

Intervention Type

Other

Trial Purpose

Other

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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