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OpenTrials
Completed

NCT Number: NCT01054807

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

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.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Coles-Brennan Pty Ltd

Hawthorn, Victoria, 3122, Australia

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Galyfilcon A Habitual Lens

Device

Comparison of three soft contact lens designs.

Galyfilcon A 8.7 BC (Investigational)

Device

Comparison of three soft contact lens designs.

Galyfilcon A 8.3 BC (Investigational)

Device

Comparison of three soft contact lens designs

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Collaborators

  • Coles-Brennan Pty Ltd

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 22, 2010
Registry last updated
Jun 19, 2018

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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