To Evaluate Eye Installation-Tear Free

NCT ID: NCT02802917

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

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-15

Study Completion Date

2015-05-24

Brief Summary

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The primary objective of this study was to compare the human eye stinging potential of experimental formulas of sun care products \[Sun Protection Factor (SPF) 50 Y49 091, SPF 50 X15 158, SPF 50 X15 160 and SPF 50 X57 162 compared to an industry standard shampoo mixture.

Detailed Description

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Conditions

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Sunscreening Agents

Keywords

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Eye stinging potential

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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SPF 50 Y49 091

Subjects were given the control article (standard shampoo mixture, X46 046) in one eye and one of the test articles in the other eye according to the randomization schedule.

Group Type EXPERIMENTAL

SPF 50 Y49 091 (BAY 987516)

Intervention Type DRUG

5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.

J & J baby shampoo, X46 046 (control)

Intervention Type OTHER

5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.

SPF 50 X15 158

Subjects were given the control article (standard shampoo mixture, X46 046) in one eye and one of the test articles in the other eye according to the randomization schedule.

Group Type EXPERIMENTAL

SPF 50 X15 158 (BAY 987516)

Intervention Type DRUG

5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.

J & J baby shampoo, X46 046 (control)

Intervention Type OTHER

5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.

SPF 50 X15 160

Subjects were given the control article (standard shampoo mixture, X46 046) in one eye and one of the test articles in the other eye according to the randomization schedule.

Group Type EXPERIMENTAL

SPF 50 X15 160 (BAY 987516)

Intervention Type DRUG

5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.

J & J baby shampoo, X46 046 (control)

Intervention Type OTHER

5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.

SPF 50 X57 162

Subjects were given the control article (standard shampoo mixture, X46 046) in one eye and one of the test articles in the other eye according to the randomization schedule.

Group Type EXPERIMENTAL

SPF 50 X57 162 (BAY 987516)

Intervention Type DRUG

5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.

J & J baby shampoo, X46 046 (control)

Intervention Type OTHER

5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.

Interventions

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SPF 50 Y49 091 (BAY 987516)

5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.

Intervention Type DRUG

SPF 50 X15 158 (BAY 987516)

5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.

Intervention Type DRUG

SPF 50 X15 160 (BAY 987516)

5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.

Intervention Type DRUG

SPF 50 X57 162 (BAY 987516)

5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.

Intervention Type DRUG

J & J baby shampoo, X46 046 (control)

5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy males or females, 18 to 60 years with no medical conditions of the eyes as determined by the subject's medical history and confirmed by an ophthalmologist
* Subjects not under any doctor's care for ocular or peri orbital diseases
* The subject will refrain from using contact lenses, any topical facial products, any eye drops, false eyelashes, make up, over the counter products, or cosmetics on their eyes, eyelids, eyelashes, or the periorbital areas of the face during the study.
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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18271

Identifier Type: -

Identifier Source: org_study_id