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A Clinical Study of Systane® Lid Wipes in Brazil

NCT ID: NCT02380261

Last Updated: 2016-11-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2015-10-31

Brief Summary

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The purpose of this study is to verify the skin and ocular tolerance of the product Systane® Lid Wipes.

Detailed Description

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Conditions

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Ocular Tolerance Skin Tolerance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

SINGLE

Participants

Study Groups

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Systane

Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days

Group Type EXPERIMENTAL

Systane® Lid Wipes

Intervention Type OTHER

Commercially-marketed, individually-packaged, pre-moistened eyelid wipe for daily cleaning

Interventions

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Systane® Lid Wipes

Commercially-marketed, individually-packaged, pre-moistened eyelid wipe for daily cleaning

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Must sign informed consent.
* Agree to adhere to the procedures and requirements of the study.
* Wears makeup daily.

Exclusion Criteria

* Pregnant or breastfeeding.
* Ocular conditions as specified in protocol.
* Medical conditions as specified in protocol.
* Skin conditions as specified in protocol.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NOVARTIS BIOCIENCIAS S/A

UNKNOWN

Sponsor Role collaborator

Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Alcon Brazil

Locations

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Novartis Biociencias SA

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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EXR338-P001

Identifier Type: -

Identifier Source: org_study_id