ClinicalTrials.gov
ClinicalTrials.gov Menu

Ophthalmic Compatibility During Seven Days of Continuous Wear of Silicone Hydrogel Lenses (QUINCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00934102
Recruitment Status : Completed
First Posted : July 8, 2009
Results First Posted : December 1, 2010
Last Update Posted : July 10, 2012
Sponsor:
Collaborator:
University of Waterloo
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Myopia Device: Narafilcon A contact lens Device: Lotrafilcon A contact lens Device: Galyfilcon A contact lens Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Ophthalmic Compatibility During Seven Days of Continuous Wear of Silicone Hydrogel Lenses (P/318/08/C)
Study Start Date : August 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Eye Wear
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Lotrafilcon A
Lotrafilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis.
Device: Lotrafilcon A contact lens
Commercially marketed, silicone hydrogel, spherical soft contact lens
Active Comparator: Narafilcon A
Narafilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis.
Device: Narafilcon A contact lens
Investigational, silicone hydrogel, spherical soft contact lens
Active Comparator: Galyfilcon A
Galyfilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis.
Device: Galyfilcon A contact lens
Commercially marketed, silicone hydrogel, spherical soft contact lens



Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00934102


Locations
Canada, Ontario
Centre for Contact Lens Research: University of Waterloo
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
CIBA VISION
University of Waterloo

Responsible Party: CIBA VISION
ClinicalTrials.gov Identifier: NCT00934102     History of Changes
Other Study ID Numbers: P-368-C-103
First Posted: July 8, 2009    Key Record Dates
Results First Posted: December 1, 2010
Last Update Posted: July 10, 2012
Last Verified: November 2010