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

This study has been completed.
Sponsor:
Collaborator:
Coles-Brennan Pty Ltd
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier:
NCT01054807
First received: January 21, 2010
Last updated: June 16, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention
Myopia Device: Galyfilcon A Habitual Lens Device: Galyfilcon A 8.7 BC (Investigational) Device: Galyfilcon A 8.3 BC (Investigational)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Vision Care, Inc.:

Primary Outcome Measures:
  • 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)


Enrollment: 32
Actual Study Start Date: November 1, 2009
Study Completion Date: March 1, 2010
Primary Completion Date: March 1, 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
GalyfilconHL/Galyfilcon8.7/Galyfilcon8.3
Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)
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
Galyfilcon8.7/Galyfilcon8.3/GalyfilconHL
Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)
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/Galyfilcon8.3/Galyfilcon8.7
Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)
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
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)
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
Galyfilcon8.3/GalyfilconHL/Galyfilcon8.7
Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)
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
Galyfilcon8.3/Galyfilcon8.7/GalyfilconHL
Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01054807

Locations
Australia, Victoria
Coles-Brennan Pty Ltd
Hawthorn, Victoria, Australia, 3122
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
Coles-Brennan Pty Ltd
Investigators
Principal Investigator: Noel Brennan, McOptom PhD Coles-Brennan Pty Ltd
  More Information

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01054807     History of Changes
Other Study ID Numbers: CR-0915
CTN# 155/2009 ( Registry Identifier: Therapeutics Goods Aministration (TGA) )
Study First Received: January 21, 2010
Last Updated: June 16, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: 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

ClinicalTrials.gov processed this record on August 23, 2017