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Completed

NCT Number: NCT02872194

Evaluation of the Stinging Potential of Products 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. The study design was a three cell, single blind study. Subjects were given the industry standard shampoo mixture in one eye and an exploratory sunscreen in the other as according to the randomization schedule.

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Key information

Conditions

Sunscreen Agents

Age range

18 year–65 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 65 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

BAY987516, Y55-170

Drug

10 uL in one eye

BAY987516, X72-151

Drug

10 uL in one eye

BAY987516, Y49-034

Drug

10 uL in one eye

Standard shampoo mixture (Control)

Drug

10 uL in one eye

Primary outcomes

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

    Time frame: up to 24 hours after instillation

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

    Time frame: up to 24 hours after instillation

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

    Time frame: up to 24 hours after instillation

  4. Post installation eye effects were assessed using a 5-category intensity score

    Time frame: up to 24 hours after instillation

Secondary outcomes

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

    Time frame: at 24 hours

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
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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