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OpenTrials
Completed

NCT Number: NCT02714166

Evaluation of the Irritation Potential of Products in Human Eyes

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

Completed

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Key information

Conditions

Sunscreening Agents

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Petersburg, Florida, 33714, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Subjective assessment of discomfort in the eyes assessed by 5 point scale.

    Time frame: Up to 1 day

  2. Intensity of Lacrimation assessed by 5 grading scale.

    Time frame: Up to 1 day

  3. Intensity of Bulbar Conjunctiva Irritation assessed by 4 grading scale.

    Time frame: Up to 1 day

  4. Intensity of Palpebral Conjunctiva Irritation assessed by 4 grading scale.

    Time frame: Up to 1 day

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 21, 2016
Registry last updated
Mar 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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