NCT02872207

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2015

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
Last Updated

December 12, 2018

Status Verified

December 1, 2018

Enrollment Period

1 day

First QC Date

August 5, 2016

Last Update Submit

December 11, 2018

Conditions

Sunscreen Agents

Outcome Measures

Primary Outcomes (11)

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

    up to 24 hours

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

    up to 24 hours

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

    at 24 hours

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

    at 24 hours

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

    at 24 hours

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

    at 24 hours

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

    at 24 hours

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

    at 24 hours

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

    at 24 hours

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

    at 24 hours

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

    at 24 hours

Secondary Outcomes (1)

  • Number of adverse events as a measure of safety and tolerabilitay

    at 24 hours

Study Arms (2)

Suncare agent 1 + control

EXPERIMENTAL

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

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

Suncare agent 2 + control

EXPERIMENTAL

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

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

Interventions

BAY 987516 (Y65-122)DRUG

5 µL in one eye

Suncare agent 1 + control
BAY 987516 (Y65-118)DRUG

5 µL in one eye

Suncare agent 2 + control
ControlDRUG

5 uL in other eye

Suncare agent 1 + controlSuncare agent 2 + control

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

St. Petersburg, Florida, 33714, United States

Location

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2016

First Posted

August 19, 2016

Study Start

February 21, 2015

Primary Completion

February 22, 2015

Study Completion

February 22, 2015

Last Updated

December 12, 2018

Record last verified: 2018-12

Locations

US(1)