Evaluation of the Stinging Potential in Human Eyes

NCT ID: NCT02872207

Last Updated: 2018-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-21

Study Completion Date

2015-02-22

Brief Summary

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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.

Detailed Description

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Conditions

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Sunscreen Agents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Suncare agent 1 + control

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

Group Type EXPERIMENTAL

BAY 987516 (Y65-122)

Intervention Type DRUG

5 µL in one eye

Control

Intervention Type DRUG

5 uL in other eye

Suncare agent 2 + control

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

Group Type EXPERIMENTAL

BAY 987516 (Y65-118)

Intervention Type DRUG

5 µL in one eye

Control

Intervention Type DRUG

5 uL in other eye

Interventions

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BAY 987516 (Y65-122)

5 µL in one eye

Intervention Type DRUG

BAY 987516 (Y65-118)

5 µL in one eye

Intervention Type DRUG

Control

5 uL in other eye

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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St. Petersburg, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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18196

Identifier Type: -

Identifier Source: org_study_id