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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00929487
First received: June 25, 2009
Last updated: September 6, 2012
Last verified: September 2012
  Purpose

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


Condition Intervention
Myopia
Device: Contact lens multi-purpose solution
Other: Saline/blister pack solution
Device: Contact lenses

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Acute Clinical Evaluation of MPS in Soft Contact Lens Wearers

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Corneal Staining [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective Comfort [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Enrollment: 278
Study Start Date: May 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Contact lens solution #1 Device: Contact lens multi-purpose solution
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
Device: Contact lenses
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:
  • PureVision
  • Air Optix Aqua
  • Acuvue Advance
  • Biofinity
Experimental: Contact lens solution #2 Device: Contact lens multi-purpose solution
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
Device: Contact lenses
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:
  • PureVision
  • Air Optix Aqua
  • Acuvue Advance
  • Biofinity
Experimental: Contact lens solution #3 Device: Contact lens multi-purpose solution
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
Device: Contact lenses
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:
  • PureVision
  • Air Optix Aqua
  • Acuvue Advance
  • Biofinity
Experimental: Contact lens solution #4 Device: Contact lens multi-purpose solution
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
Device: Contact lenses
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:
  • PureVision
  • Air Optix Aqua
  • Acuvue Advance
  • Biofinity
Active Comparator: Saline/blister pack solution Other: Saline/blister pack solution
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:
  • AMO OcuPure Saline
  • Saline
Device: Contact lenses
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:
  • PureVision
  • Air Optix Aqua
  • Acuvue Advance
  • Biofinity

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00929487

Locations
United Kingdom
Visioncare Research, Ltd.
Farnham, Surrey, United Kingdom, GU9 7EN
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided by Alcon Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00929487     History of Changes
Other Study ID Numbers: SMA-09-14/RDG-11-152
Study First Received: June 25, 2009
Last Updated: September 6, 2012
Health Authority: United Kingdom: Research Ethics Committee
France: Institutional Ethical Committee
Philippines: Ethics Committee

Keywords provided by Alcon Research:
contact lens wear
contact lens solution
corneal staining

Additional relevant MeSH terms:
Pharmaceutical Solutions
Contact Lens Solutions
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Anti-Infective Agents

ClinicalTrials.gov processed this record on October 19, 2014