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Completed

NCT Number: NCT00929487

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

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

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Visioncare Research, Ltd.

Farnham, Surrey, GU9 7EN, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Contact lens multi-purpose solution

Device

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

Saline/blister pack solution

Other

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

Contact Lenses

Device

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

Primary outcomes

  1. Corneal Staining

    Time frame: 2 hours

Secondary outcomes

  1. Subjective Comfort

    Time frame: 2 hours

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Acute Clinical Evaluation of MPS in Soft Contact Lens Wearers

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 29, 2009
Registry last updated
Sep 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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