- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02728856
Evaluation of the Irritation Potential of Products in Human Eyes.
March 30, 2017 updated by: Bayer
Evaluation of the Irritation Potential of Products in Human Eyes
To evaluate the human eye irritation potential of two test sunscreen formulation
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
St. Petersburg, Florida, United States, 33714
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sun Protection Factor (SPF) 50 Z15-034(BAY987516)
Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.
|
Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.
Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.
|
Experimental: Sunscreen Spray SPF50 Z15-038(BAY987516)
Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.
|
Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.
Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Subjective assessment of discomfort in the eyes assessed by 5 point scale
Time Frame: Up to 1 day
|
Up to 1 day
|
Intensity of Lacrimation assessed by 5 grading scale
Time Frame: Up to 1 day
|
Up to 1 day
|
Intensity of Bulbar Conjunctiva Irritation assessed by 4 grading scale
Time Frame: Up to 1 day
|
Up to 1 day
|
Intensity of Palpebral Conjunctiva Irritation assessed by 4 grading scale
Time Frame: Up to 1 day
|
Up to 1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 27, 2016
Primary Completion (Actual)
February 27, 2016
Study Completion (Actual)
February 27, 2016
Study Registration Dates
First Submitted
March 3, 2016
First Submitted That Met QC Criteria
March 31, 2016
First Posted (Estimate)
April 5, 2016
Study Record Updates
Last Update Posted (Actual)
March 31, 2017
Last Update Submitted That Met QC Criteria
March 30, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18598
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sunscreening Agents
-
HALEONCompletedSunscreening AgentsUnited States
-
BayerTerminated
-
BayerCompletedSunscreening AgentsUnited States
-
HALEONCompletedSunscreening AgentsUnited States