Evaluation of the Irritation Potential of Products in Human Eyes.

NCT02728856 | Completed

• 1 other identifier: 18598
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sunscreening Agents

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Sun Protection Factor (SPF) 50 Z15-034(BAY987516)

EXPERIMENTAL

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 Spray SPF50 Z15-034(BAY987516); Other: Shampoo Control

Sunscreen Spray SPF50 Z15-038(BAY987516)

EXPERIMENTAL

Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.

Other: Shampoo Control; Other: Sunscreen Spray SPF50 Z15-038(BAY987516)

Interventions

Sunscreen Spray SPF50 Z15-034(BAY987516) OTHER

Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.

Sun Protection Factor (SPF) 50 Z15-034(BAY987516)

Shampoo Control OTHER

Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.

Sun Protection Factor (SPF) 50 Z15-034(BAY987516); Sunscreen Spray SPF50 Z15-038(BAY987516)

Sunscreen Spray SPF50 Z15-038(BAY987516) OTHER

Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.

Sunscreen Spray SPF50 Z15-038(BAY987516)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

St. Petersburg, Florida, 33714, United States

Location

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: April 5, 2016
• Study Start: February 27, 2016
• Primary Completion: February 27, 2016
• Study Completion: February 27, 2016
• Last Updated: March 31, 2017

Record last verified: 2017-03

Locations

US (1)