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

This study has been completed.
Sponsor:
Collaborator:
University of Waterloo
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT00934102
First received: July 6, 2009
Last updated: June 26, 2012
Last verified: November 2010
  Purpose

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 Intervention
Myopia
Device: Narafilcon A contact lens
Device: Lotrafilcon A contact lens
Device: Galyfilcon A contact lens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Ophthalmic Compatibility During Seven Days of Continuous Wear of Silicone Hydrogel Lenses (P/318/08/C)

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Front Surface Lens Deposits [ Time Frame: Period 2, Day 6 ] [ Designated as safety issue: No ]
    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.


Enrollment: 57
Study Start Date: August 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
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
  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: 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
  More Information

No publications provided

Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT00934102     History of Changes
Other Study ID Numbers: P-368-C-103
Study First Received: July 6, 2009
Results First Received: November 1, 2010
Last Updated: June 26, 2012
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on October 01, 2014