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OpenTrials
Completed

NCT Number: NCT00934102

Ophthalmic Compatibility During Seven Days of Continuous Wear of Silicone Hydrogel Lenses

The purpose of this study is to assess the ophthalmic compatibility of three different silicone hydrogel lenses worn on an overnight basis for six nights.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Contact Lens Research: University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Is at least 17 years of age and has full legal capacity to volunteer
  • Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual vision correction
  • Has had an ocular examination in the last two years
  • Is a current soft (hydrogel or silicone hydrogel) contact lens wearer
  • Has clear corneas and no active ocular disease
  • Can be successfully fit with the lenses to be used in the study
  • Other protocol-defined inclusion/exclusion criteria may apply

Exclusion criteria

  • Is pregnant or lactating
  • Has undergone corneal refractive surgery
  • Currently wears lenses on an extended wear basis or was on extended wear within six months prior to the study
  • Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Narafilcon A contact lens

Device

Investigational, silicone hydrogel, spherical soft contact lens

Lotrafilcon A contact lens

Device

Commercially marketed, silicone hydrogel, spherical soft contact lens

Galyfilcon A contact lens

Device

Commercially marketed, silicone hydrogel, spherical soft contact lens

Primary outcomes

  1. Front Surface Lens Deposits

    Time frame: Period 2, Day 6

    Protein and lipid deposits on the contact lens surface as assessed by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4 with 0 being none and 4 being severe.

Sponsors and collaborators

Lead sponsor

CIBA VISION

Industry

Collaborators

  • University of Waterloo

Registry information

Official study title

Ophthalmic Compatibility During Seven Days of Continuous Wear of Silicone Hydrogel Lenses (P/318/08/C)

Acronym: QUINCE

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 8, 2009
Registry last updated
Jul 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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