A Clinical Study of Systane® Lid Wipes in Brazil

September 29, 2016 updated by: Alcon Research

Assessment Of The Skin And Ocular Tolerance Of The Product Systane® Lid Wipes (050343-01) And Assessment Of The Study Subject Acceptance, Under Normal Use Conditions

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 04636-000
        • Novartis Biociencias SA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must sign informed consent.
  • Agree to adhere to the procedures and requirements of the study.
  • Wears makeup daily.
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Pregnant or breastfeeding.
  • Ocular conditions as specified in protocol.
  • Medical conditions as specified in protocol.
  • Skin conditions as specified in protocol.
  • Other protocol-specified exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Systane
Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
Other: Systane® Lid Wipes
Commercially-marketed, individually-packaged, pre-moistened eyelid wipe for daily cleaning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With a Contact-dermatitis Adverse Reaction
Time Frame: Day 21
Participants were assessed by a dermatologist. Contact-dermatitis adverse reaction was characterized by the presence of one or more of the following symptoms or signs: strong itching sensation, erythema, edema, desquamation, papules or vesicles. Both eyes contributed to the analysis.
Day 21
Number of Participants With Ocular Clinical Signs and Discomfort Sensations
Time Frame: Day 21
Participants were assessed by an ophthalmologist. Ocular clinical signs included palpebral edema, conjunctival edema, orbicular secretion, keratoconus, blepharitis, meibomitis, pterygium, hyperemia, chemosis, keratitis, secretion and lacrimation. Both eyes contributed to the analysis.
Day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Collaborators

NOVARTIS BIOCIENCIAS S/A

Investigators

  • Study Director: Medical Director, Alcon Brazil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (ACTUAL)

October 1, 2015

Study Completion (ACTUAL)

October 1, 2015

Study Registration Dates

First Submitted

February 27, 2015

First Submitted That Met QC Criteria

March 4, 2015

First Posted (ESTIMATE)

March 5, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

November 18, 2016

Last Update Submitted That Met QC Criteria

September 29, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • EXR338-P001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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