NCT02869113

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
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 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

January 23, 2015

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
Last Updated

December 12, 2018

Status Verified

December 1, 2018

Enrollment Period

1 day

First QC Date

August 3, 2016

Last Update Submit

December 11, 2018

Conditions

Sunscreen Agents

Outcome Measures

Primary Outcomes (4)

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

    up to 24 hours

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

    up to 24 hours

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

    up to 24 hours

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

    up to 24 hours

Secondary Outcomes (1)

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

    at 24 hours

Study Arms (3)

Sunscreen agent A + control

EXPERIMENTAL

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

Drug: BAY98751 (Y65-110)Drug: Standard shampoo mixture (Control)

Sunscreen agent B + control

EXPERIMENTAL

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

Drug: BAY 98751 (Y65-102)Drug: Standard shampoo mixture (Control)

Sunscreen agent C + control

EXPERIMENTAL

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

Drug: BAY 98751 (Y65-106)Drug: Standard shampoo mixture (Control)

Interventions

BAY98751 (Y65-110)DRUG

10 µL in one eye

Sunscreen agent A + control
BAY 98751 (Y65-102)DRUG

10 µL in one eye

Sunscreen agent B + control
BAY 98751 (Y65-106)DRUG

10 µL in one eye

Sunscreen agent C + control
Standard shampoo mixture (Control)DRUG

10 µL in other eye

Sunscreen agent A + controlSunscreen agent B + controlSunscreen agent C + 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
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2016

First Posted

August 16, 2016

Study Start

January 23, 2015

Primary Completion

January 24, 2015

Study Completion

January 24, 2015

Last Updated

December 12, 2018

Record last verified: 2018-12

Locations

US(1)