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Completed

NCT Number: NCT02872207

Evaluation of the Stinging Potential in Human Eyes

The objective of this study was to compare the human eye stinging potential of experimental formulas and an industry standard shampoo mixture. The study was conducted under the supervision of a Board Certified Ophthalmologist.

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Key information

Conditions

Sunscreen 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

  • Male or female subjects, aged 18 to 60 years
  • No medical conditions of the eyes as determined by the subjects' medical history and confirmed by ophthalmologist
  • Subjects do not wear contact lenses or, if he/she does wear contact lenses, is willing to refrain from wearing these during the day of and day after the study
  • Subject is willing to have the test materials instilled into the eyes and follow all protocol requirements
  • Subject is willing to refrain from using false eyelashes of any type or any topical prescription, OTC or cosmetic products on their eyes, eyelids, eyelashes or the peri-orbital areas of the face on the day of the study.
  • Subjects should refrain from use of make-up on testing day

Treatment and study plan

BAY 987516 (Y65-122)

Drug

5 µL in one eye

BAY 987516 (Y65-118)

Drug

5 µL in one eye

Control

Drug

5 uL in other eye

Primary outcomes

  1. Subjective discomfort in the eye was assessed based on questions by an Ophthalmologist to the subject, and a 5-category intensity scale.

    Time frame: up to 24 hours

  2. Tearing/Lacrimation was assessed by the Ophthalmologist using a 5-category assessment score for each of the categories

    Time frame: up to 24 hours

  3. Objective inflammation was assessed by the Ophthalmologist using a 5-category assessment score for each of the categories

    Time frame: at 24 hours

  4. Post installation pain/stinging was assessed using a 5-category intensity score

    Time frame: at 24 hours

  5. Post installation itching was assessed using a 5-category intensity score

    Time frame: at 24 hours

  6. Post installation dryness was assessed using a 5-category intensity score

    Time frame: at 24 hours

  7. Post installation scratchiness was assessed using a 5-category intensity score

    Time frame: at 24 hours

  8. Post installation discomfort preventing sleep was assessed using a 5-category intensity score

    Time frame: at 24 hours

  9. Post installation discomfort upon awakening was assessed using a 5-category intensity score

    Time frame: at 24 hours

  10. Post installation excessive discharge upon awakening was assessed using a 5-category intensity score

    Time frame: at 24 hours

  11. Post installation pain in bright sunlight was assessed using a 5-category intensity score

    Time frame: at 24 hours

Secondary outcomes

  1. Number of adverse events as a measure of safety and tolerabilitay

    Time frame: at 24 hours

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 19, 2016
Registry last updated
Dec 12, 2018

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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