Evaluation of the Irritation Potential of Products in Human Eyes

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

Study Overview

• Status: Completed
• Conditions: Sunscreening Agents
• Intervention / Treatment: Other: Sunscreen lotion SPF (Sun Protection Factor) 50 (BAY987521); Other: Ophthalmic Ointment

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • St. Petersburg, Florida, United States, 33714

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• 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, 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sunscreen lotion Sun Protection Factor 50 (BAY987521); Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.	Other: Sunscreen lotion SPF (Sun Protection Factor) 50 (BAY987521); Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.
Other: Ophthalmic Ointment; Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.	Other: Ophthalmic Ointment; 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.	Up to 1 day
Intensity of Lacrimation assessed by 5 grading scale.	Up to 1 day
Intensity of Bulbar Conjunctiva Irritation assessed by 4 grading scale.	Up to 1 day
Intensity of Palpebral Conjunctiva Irritation assessed by 4 grading scale.	Up to 1 day

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2016
• Primary Completion (Actual): February 26, 2016
• Study Completion (Actual): February 26, 2016

Study Registration Dates

• First Submitted: March 4, 2016
• First Submitted That Met QC Criteria: March 16, 2016
• First Posted (Estimate): March 21, 2016

Study Record Updates

• Last Update Posted (Actual): March 30, 2017
• Last Update Submitted That Met QC Criteria: March 29, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Dermatologic Agents; Radiation-Protective Agents; Sunscreening Agents
• Other Study ID Numbers: 18766