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Clinical Comparison of Two Silicone-Hydrogel Contact Lenses

Primary Purpose

Refractive Error

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
galyfilcon A
comfilcon A
Sponsored by
Johnson & Johnson Vision Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Error

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The subject must be at least 18 and less than or equal to 39 years of age and have a need for vision correction in both eyes.
  • The subject must require a lens power between -1.00 to -6.00D and have no more than 1.00D of corneal cylinder.
  • The subject, based on his/her knowledge, must be in good general health.
  • The subject must be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluations.
  • Subject must be a current adapted daily wearer of soft contact lenses with at least 6 months of CL wear.
  • Subject must agree to wear their contact lenses in both eyes on a daily wear schedule for at least 8 hours per day every day during the study.
  • Subject must be willing and able to use only the care systems and lubricating drops provided for the study during the 4 week period.
  • The subject must read, indicate understanding of and sign the Informed Consent Form.

Exclusion Criteria:

  • The subject is a rigid gas permeable (RGP) or daily disposable lens wearer.
  • The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids or associated structures.
  • The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjogren's syndrome, type II diabetes, etc.)

  • Slit lamp findings that would contraindicate contact lens wear such as:

    • pathological dry eye or associated findings
    • pterygium or corneal scars within the visual axis
    • neovascularization equal to or greater than 1mm in from the limbus
    • history of giant papillary conjunctivitis (GPC) worse than grade 2
    • anterior uveitis or iritis (past or present)
    • seborrhoeic eczema
    • seborrhoeic conjunctivitis
  • A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections.
  • A known history of corneal hypoesthesia (reduced corneal sensitivity).
  • Contact lens snellen visual acuities (VA) worse than 20/30.
  • Aphakia, keratoconus or a highly irregular cornea.
  • Current pregnancy or lactation (to the best of the subject's knowledge)
  • Any active participation in another clinical study at any time during this study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    galyfilcon A/comfilcon A

    comfilcon A/galyfilcon A

    Arm Description

    galyfilcon A first, comfilcon A second

    comfilcon A first, galyfilcon A second

    Outcomes

    Primary Outcome Measures

    Lens Comfort
    >0 = comfortable, <0 = uncomfortable; a weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes.
    Comfort Symptoms
    A weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes. >0 = comfortable, <0 = uncomfortable

    Secondary Outcome Measures

    Overall Corneal Staining
    Measured for 5 zones of the cornea (superior, nasal, central, inferior, temporal)on a 0 to 3 grade scale (NEI 0-3 scale). Grade 0 = Normal/ grade 1 = mild, superficial stippling/ grade 2 = moderate, punctate staining including superficial abrasion of the cornea/ grade 3 = severe, abrasion or corneal erosion, deep corneal abrasion or recurrent erosion.

    Full Information

    First Posted
    September 29, 2008
    Last Updated
    June 18, 2018
    Sponsor
    Johnson & Johnson Vision Care, Inc.
    Collaborators
    Foresight Regulatory Strategies, Inc., Visioncare Research Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00762385
    Brief Title
    Clinical Comparison of Two Silicone-Hydrogel Contact Lenses
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2007 (undefined)
    Primary Completion Date
    October 2007 (Actual)
    Study Completion Date
    October 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johnson & Johnson Vision Care, Inc.
    Collaborators
    Foresight Regulatory Strategies, Inc., Visioncare Research Ltd.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The objective of this study is to evaluate the clinical performance of two silicone-hydrogel contact lenses.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Refractive Error

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    97 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    galyfilcon A/comfilcon A
    Arm Type
    Active Comparator
    Arm Description
    galyfilcon A first, comfilcon A second
    Arm Title
    comfilcon A/galyfilcon A
    Arm Type
    Active Comparator
    Arm Description
    comfilcon A first, galyfilcon A second
    Intervention Type
    Device
    Intervention Name(s)
    galyfilcon A
    Intervention Description
    galyfilcon A
    Intervention Type
    Device
    Intervention Name(s)
    comfilcon A
    Intervention Description
    comfilcon A
    Primary Outcome Measure Information:
    Title
    Lens Comfort
    Description
    >0 = comfortable, <0 = uncomfortable; a weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes.
    Time Frame
    1-week, 2- weeks
    Title
    Comfort Symptoms
    Description
    A weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes. >0 = comfortable, <0 = uncomfortable
    Time Frame
    1-week, 2-weeks
    Secondary Outcome Measure Information:
    Title
    Overall Corneal Staining
    Description
    Measured for 5 zones of the cornea (superior, nasal, central, inferior, temporal)on a 0 to 3 grade scale (NEI 0-3 scale). Grade 0 = Normal/ grade 1 = mild, superficial stippling/ grade 2 = moderate, punctate staining including superficial abrasion of the cornea/ grade 3 = severe, abrasion or corneal erosion, deep corneal abrasion or recurrent erosion.
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    39 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The subject must be at least 18 and less than or equal to 39 years of age and have a need for vision correction in both eyes. The subject must require a lens power between -1.00 to -6.00D and have no more than 1.00D of corneal cylinder. The subject, based on his/her knowledge, must be in good general health. The subject must be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluations. Subject must be a current adapted daily wearer of soft contact lenses with at least 6 months of CL wear. Subject must agree to wear their contact lenses in both eyes on a daily wear schedule for at least 8 hours per day every day during the study. Subject must be willing and able to use only the care systems and lubricating drops provided for the study during the 4 week period. The subject must read, indicate understanding of and sign the Informed Consent Form. Exclusion Criteria: The subject is a rigid gas permeable (RGP) or daily disposable lens wearer. The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids or associated structures. The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjogren's syndrome, type II diabetes, etc.) Slit lamp findings that would contraindicate contact lens wear such as: pathological dry eye or associated findings pterygium or corneal scars within the visual axis neovascularization equal to or greater than 1mm in from the limbus history of giant papillary conjunctivitis (GPC) worse than grade 2 anterior uveitis or iritis (past or present) seborrhoeic eczema seborrhoeic conjunctivitis A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections. A known history of corneal hypoesthesia (reduced corneal sensitivity). Contact lens snellen visual acuities (VA) worse than 20/30. Aphakia, keratoconus or a highly irregular cornea. Current pregnancy or lactation (to the best of the subject's knowledge) Any active participation in another clinical study at any time during this study.

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Comparison of Two Silicone-Hydrogel Contact Lenses

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