Evaluation of the Irritation Potential of Products in Human Eyes

NCT02714166 | Completed

• 1 other identifier: 18766
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the human eye irritation potential of one 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)

Sunscreen lotion Sun Protection Factor 50 (BAY987521)

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 lotion SPF (Sun Protection Factor) 50 (BAY987521)

Ophthalmic Ointment

OTHER

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

Interventions

Sunscreen lotion SPF (Sun Protection Factor) 50 (BAY987521) 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 lotion Sun Protection Factor 50 (BAY987521)

Ophthalmic Ointment OTHER

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

Ophthalmic Ointment

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, 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

St. Petersburg, Florida, 33714, United States

Location

MeSH Terms

Interventions

Sun Protection Factor

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Radiometry

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 4, 2016
• First Posted: March 21, 2016
• Study Start: February 26, 2016
• Primary Completion: February 26, 2016
• Study Completion: February 26, 2016
• Last Updated: March 30, 2017

Record last verified: 2017-03

Locations

US (1)