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Non-Dispensing Evaluation of an Investigational Galyfilcon A Soft Contact Lens

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01054807
First Posted: January 22, 2010
Last Update Posted: June 20, 2017
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.
Collaborator:
Coles-Brennan Pty Ltd
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.
January 21, 2010
January 22, 2010
June 20, 2017
November 1, 2009
March 1, 2010   (Final data collection date for primary outcome measure)
  • Comparison of Lens Fit Characteristics [ Time Frame: Approximately 40 minutes of wear time ]

    At the screening visit, the following baseline measurements will be taken of the subject's habitual contact lenses (Control):

    • Visual Acuity (logMar)
    • Over-refraction with Visual Acuity
    • Fit acceptability (acceptable/non-acceptable)
  • Evaluation of Inter-Changeability [ Time Frame: Approximately 40 minutes of wear time ]

    In a bilateral fashion, the subject will wear Test/Control lens according to a pre-designed randomization schedule. Immediately upon insertion, the following variables will be assessed:

    • Ease of handling of the lenses- by Investigator
    • Comfort on insertion

    After 30-40 minutes of settling time the following variables will be collected:

    • Subjective comfort after settling
    • Visual Acuity (logMar)
    • Corneal coverage (Y/N)
    • Post-blink movement (mm)
    • Version Lag (mm)
    • Tightness on push-up (0-100 scale)
    • Overall fit acceptance (0-5 scale)
  • Determination of fit or Vision Differences [ Time Frame: Approximately 40 minutes of wear time ]

    In a bilateral fashion, the subject will wear Test/Control lens according to a pre-designed randomization schedule. Immediately upon insertion, the following variables will be assessed:

    • Ease of handling of the lenses- by Investigator
    • Comfort on insertion

    After 30-40 minutes of settling time the following variables will be collected:

    • Subjective comfort after settling
    • Visual Acuity (logMar)
    • Corneal coverage (Y/N)
    • Post-blink movement (mm)
    • Version Lag (mm)
    • Tightness on push-up (0-100 scale)
    • Overall fit acceptance (0-5 scale)
Not Provided
Complete list of historical versions of study NCT01054807 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Non-Dispensing Evaluation of an Investigational Galyfilcon A Soft Contact Lens
Not Provided
The purpose of this investigation is to compare the fit characteristics and vision attributes of an investigational Galyfilcon A contact lens and an approved Galyfilcon A contact lens.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Myopia
  • Device: Galyfilcon A Habitual Lens
    Comparison of three soft contact lens designs.
  • Device: Galyfilcon A 8.7 BC (Investigational)
    Comparison of three soft contact lens designs.
  • Device: Galyfilcon A 8.3 BC (Investigational)
    Comparison of three soft contact lens designs
  • GalyfilconHL/Galyfilcon8.7/Galyfilcon8.3
    Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)
    Interventions:
    • Device: Galyfilcon A Habitual Lens
    • Device: Galyfilcon A 8.7 BC (Investigational)
    • Device: Galyfilcon A 8.3 BC (Investigational)
  • Galyfilcon8.7/Galyfilcon8.3/GalyfilconHL
    Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)
    Interventions:
    • Device: Galyfilcon A Habitual Lens
    • Device: Galyfilcon A 8.7 BC (Investigational)
    • Device: Galyfilcon A 8.3 BC (Investigational)
  • GalyfilconHL/Galyfilcon8.3/Galyfilcon8.7
    Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)
    Interventions:
    • Device: Galyfilcon A Habitual Lens
    • Device: Galyfilcon A 8.7 BC (Investigational)
    • Device: Galyfilcon A 8.3 BC (Investigational)
  • Galyfilcon 8.7/Galyfilcon HL/Galyfilcon 8.3
    Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator) /Galyfilcon A 8.3 BC (Experimental)
    Interventions:
    • Device: Galyfilcon A Habitual Lens
    • Device: Galyfilcon A 8.7 BC (Investigational)
    • Device: Galyfilcon A 8.3 BC (Investigational)
  • Galyfilcon8.3/GalyfilconHL/Galyfilcon8.7
    Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)
    Interventions:
    • Device: Galyfilcon A Habitual Lens
    • Device: Galyfilcon A 8.7 BC (Investigational)
    • Device: Galyfilcon A 8.3 BC (Investigational)
  • Galyfilcon8.3/Galyfilcon8.7/GalyfilconHL
    Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)
    Interventions:
    • Device: Galyfilcon A Habitual Lens
    • Device: Galyfilcon A 8.7 BC (Investigational)
    • Device: Galyfilcon A 8.3 BC (Investigational)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
March 1, 2010
March 1, 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Be of legal age (i.e., at least 18 years old)
  • Sign a written informed consent
  • Have contact lens distance sphere requirement in the range -1.00D to -6.00D
  • Have spectacle astigmatism <1.25D in each eye
  • Currently wear ACUVUE® ADVANCE™ (for at least 6 months) with documentation of current prescription.
  • Have normal eyes with no evidence of abnormality or disease.

Exclusion Criteria:

  • Required concurrent ocular medication
  • Any systemic illness which would contra-indicate lens wear or the medical treatment of which would affect vision or successful lens wear.
  • Eye injury or surgery within eight weeks immediately prior to enrollment for this study.
  • Abnormal lacrimal secretions
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Keratoconus or other corneal irregularity.
  • Pregnancy, lactating or planning a pregnancy at the time of enrolment.
  • Participation in any concurrent clinical trial
  • Known allergy to silver, silver ions, or silver containing compounds.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
 
NCT01054807
CR-0915
CTN# 155/2009 ( Registry Identifier: Therapeutics Goods Aministration (TGA) )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Plan to Share IPD: No
Johnson & Johnson Vision Care, Inc.
Johnson & Johnson Vision Care, Inc.
Coles-Brennan Pty Ltd
Principal Investigator: Noel Brennan, McOptom PhD Coles-Brennan Pty Ltd
Johnson & Johnson Vision Care, Inc.
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP