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CompletedNCT02872207Updated Dec 12, 2018

Evaluation of the Stinging Potential in Human Eyes

An interventional study of BAY 987516 (Y65-122) and BAY 987516 (Y65-118) in Sunscreen Agents, sponsored by Bayer. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-12.

Sponsored by Bayer · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Feb 2015, registered Aug 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Sunscreen Agents
03

In context

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Suncare agent 1 + control

    Application of control and test product into one of the subjects two eyes.

    Drug: BAY 987516 (Y65-122) · Drug: Control

  • Experimental
    Suncare agent 2 + control

    Application of control and test product into one of the subjects two eyes.

    Drug: BAY 987516 (Y65-118) · Drug: Control

Interventions

  • DrugBAY 987516 (Y65-122)

    5 µL in one eye

  • DrugBAY 987516 (Y65-118)

    5 µL in one eye

  • DrugControl

    5 uL in other eye

06

What researchers measure

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

07

Study locations

1 site
  • Saint Petersburg, Florida 33714, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02872207
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Aug 19, 2016
Start date
Feb 21, 2015
Primary completion
Feb 22, 2015
Completion
Feb 22, 2015
Last update
Dec 12, 2018

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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