Acute Clinical Evaluation of Multi-purpose Solutions (MPS) in Soft Contact Lens Wearers

September 6, 2012 updated by: Alcon Research

Acute Clinical Evaluation of MPS in Soft Contact Lens Wearers

The purpose of this study was to clinically evaluate lens care solutions used with soft contact lenses.

Study Overview

Detailed Description

This study was conducted as a series of ten smaller studies in three countries using commercially available contact lens solutions per each country, ie, United Kingdom, France, and the Philippines. In each study, participants were assessed after use of up to 5 products (with one always being a control saline/blister pack solution) in randomized order in conjunction with one of the silicone hydrogel contact lenses. A total of 278 participants were enrolled in the 10 studies.

Study Type

Interventional

Enrollment (Actual)

278

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

    • Surrey
      • Farnham, Surrey, United Kingdom, GU9 7EN
        • Visioncare Research, Ltd.

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have read, understood, signed, and dated the written Informed Consent.
  • Be an adapted and successful soft contact lens wearer on a daily wear basis for at least two weeks.
  • Vision correctable to at least 20/30 Snellen.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Topical ocular medication use.
  • History of hypersensitivity to any component of the study contact lens care systems.
  • Any slit-lamp finding of abnormal nature at the baseline visit assessment of each study period.
  • Pregnant, lactating, or planning a pregnancy.
  • Other protocol-defined 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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Contact lens solution #1
Lens care solutions CE-marked for intended use. A fresh pair of contact lenses was soaked overnight in the test contact lens solution and a pre-cycled lens case prior to study visit, then worn for two hours on the day of the study visit. Up to four solutions were evaluated in randomized order with the same brand of contact lenses, and a minimum of 12 hours of no lens wear separated each wear period.
Other Names:
  • ReNu Multiplus
  • Ote Hydroshield
  • Sauflon Synergi
  • Lapis Lazuli Eye See Aqua Balance
  • Avizor All Clean Soft
  • Sauflon Cyclean
  • Vita Research Regard
  • Menicon MeniCare Soft
  • ALL
  • ReNu MPS
  • Welcon
  • Hydron
CE-marked silicone hydrogel contact lenses soaked overnight for at least 10 hours prior to the study visit, then worn for two hours on the day of the study visit. A fresh pair of the same brand of contact lenses was used for each overnight soak (ie, 4 solutions plus saline/blister pack solution), and a minimum of 12 hours separated each wear period.
Other Names:
  • Biofinity
  • PureVision
  • Air Optix Aqua
  • Acuvue Advance
Experimental: Contact lens solution #2
Lens care solutions CE-marked for intended use. A fresh pair of contact lenses was soaked overnight in the test contact lens solution and a pre-cycled lens case prior to study visit, then worn for two hours on the day of the study visit. Up to four solutions were evaluated in randomized order with the same brand of contact lenses, and a minimum of 12 hours of no lens wear separated each wear period.
Other Names:
  • ReNu Multiplus
  • Ote Hydroshield
  • Sauflon Synergi
  • Lapis Lazuli Eye See Aqua Balance
  • Avizor All Clean Soft
  • Sauflon Cyclean
  • Vita Research Regard
  • Menicon MeniCare Soft
  • ALL
  • ReNu MPS
  • Welcon
  • Hydron
CE-marked silicone hydrogel contact lenses soaked overnight for at least 10 hours prior to the study visit, then worn for two hours on the day of the study visit. A fresh pair of the same brand of contact lenses was used for each overnight soak (ie, 4 solutions plus saline/blister pack solution), and a minimum of 12 hours separated each wear period.
Other Names:
  • Biofinity
  • PureVision
  • Air Optix Aqua
  • Acuvue Advance
Experimental: Contact lens solution #3
Lens care solutions CE-marked for intended use. A fresh pair of contact lenses was soaked overnight in the test contact lens solution and a pre-cycled lens case prior to study visit, then worn for two hours on the day of the study visit. Up to four solutions were evaluated in randomized order with the same brand of contact lenses, and a minimum of 12 hours of no lens wear separated each wear period.
Other Names:
  • ReNu Multiplus
  • Ote Hydroshield
  • Sauflon Synergi
  • Lapis Lazuli Eye See Aqua Balance
  • Avizor All Clean Soft
  • Sauflon Cyclean
  • Vita Research Regard
  • Menicon MeniCare Soft
  • ALL
  • ReNu MPS
  • Welcon
  • Hydron
CE-marked silicone hydrogel contact lenses soaked overnight for at least 10 hours prior to the study visit, then worn for two hours on the day of the study visit. A fresh pair of the same brand of contact lenses was used for each overnight soak (ie, 4 solutions plus saline/blister pack solution), and a minimum of 12 hours separated each wear period.
Other Names:
  • Biofinity
  • PureVision
  • Air Optix Aqua
  • Acuvue Advance
Experimental: Contact lens solution #4
Lens care solutions CE-marked for intended use. A fresh pair of contact lenses was soaked overnight in the test contact lens solution and a pre-cycled lens case prior to study visit, then worn for two hours on the day of the study visit. Up to four solutions were evaluated in randomized order with the same brand of contact lenses, and a minimum of 12 hours of no lens wear separated each wear period.
Other Names:
  • ReNu Multiplus
  • Ote Hydroshield
  • Sauflon Synergi
  • Lapis Lazuli Eye See Aqua Balance
  • Avizor All Clean Soft
  • Sauflon Cyclean
  • Vita Research Regard
  • Menicon MeniCare Soft
  • ALL
  • ReNu MPS
  • Welcon
  • Hydron
CE-marked silicone hydrogel contact lenses soaked overnight for at least 10 hours prior to the study visit, then worn for two hours on the day of the study visit. A fresh pair of the same brand of contact lenses was used for each overnight soak (ie, 4 solutions plus saline/blister pack solution), and a minimum of 12 hours separated each wear period.
Other Names:
  • Biofinity
  • PureVision
  • Air Optix Aqua
  • Acuvue Advance
Active Comparator: Saline/blister pack solution
CE-marked silicone hydrogel contact lenses soaked overnight for at least 10 hours prior to the study visit, then worn for two hours on the day of the study visit. A fresh pair of the same brand of contact lenses was used for each overnight soak (ie, 4 solutions plus saline/blister pack solution), and a minimum of 12 hours separated each wear period.
Other Names:
  • Biofinity
  • PureVision
  • Air Optix Aqua
  • Acuvue Advance
A fresh pair of contact lenses was soaked overnight in saline prior to study visit or was inserted directly from the blister pack, then worn for two hours on the day of the study visit.
Other Names:
  • Saline
  • AMO OcuPure Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Corneal Staining
Time Frame: 2 hours
2 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Subjective Comfort
Time Frame: 2 hours
2 hours

Collaborators and Investigators

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

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

May 1, 2009

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

June 25, 2009

First Submitted That Met QC Criteria

June 26, 2009

First Posted (Estimate)

June 29, 2009

Study Record Updates

Last Update Posted (Estimate)

September 10, 2012

Last Update Submitted That Met QC Criteria

September 6, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • SMA-09-14/RDG-11-152

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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