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Dispensing Evaluation of a Galyfilcon A Prototype Lens and a Marketed Contact Lens

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ClinicalTrials.gov Identifier: NCT01180985
Recruitment Status : Completed
First Posted : August 13, 2010
Results First Posted : February 5, 2014
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Study Description
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Brief Summary:
The purpose of this study is to compare visual acuity and redness of eyes between a prototype contact lens and an already marketed contact lens.

Condition or disease Intervention/treatment Phase
Myopia Device: galyfilcon A prototype lens Device: comfilcon A Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : June 1, 2010
Actual Primary Completion Date : July 1, 2010
Actual Study Completion Date : July 1, 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
galyfilcon A prototype/comfilcon A
The galyfilcon A prototype lenses are worn during first period and comfilcon A lenses worn during second period. Each period consists of daily lens wear for one week.
 Device: galyfilcon A prototype lens
silicone hydrogel contact lens

Device: comfilcon A
silicone hydrogel contact lens
Other Name: Biofinity® contact lens
comfilcon A/galyfilcon A prototype
The comfilcon A lenses are worn during first period and galyfilcon A prototype lenses worn during second period. Each period consists of daily lens wear for one week.
 Device: galyfilcon A prototype lens
silicone hydrogel contact lens

Device: comfilcon A
silicone hydrogel contact lens
Other Name: Biofinity® contact lens


Outcome Measures
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Primary Outcome Measures :
  1. Visual Acuity Monocular [ Time Frame: after 7 +/- 1 days of lens wear ]
    Snellen monocular visual acuity measurement was measured in both eyes that wore lenses for one week and came in for the evaluation with an inserted lens.

  2. Visual Acuity Binocular [ Time Frame: after 7 +/- 1 days of lens wear ]
    Snellen binocular visual acuity measurement

  3. Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire. [ Time Frame: after 7 +/-1 days of lens wear ]
    The contract Lens Experience (CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.

  4. Subjective Assessment of Quality of Vision Using the Contact Lens User Experience(CLUE)TM Questionnaire. [ Time Frame: after 7 +/- 1 days of lens wear ]
    Contact Lens User Experience CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.


Secondary Outcome Measures :
  1. Limbal Redness [ Time Frame: after 7 days of lens wear ]
    Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.

  2. Bulbar Redness [ Time Frame: after 7 days of lens wear ]
    Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.

  3. Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire. [ Time Frame: 10 minutes after lens insertion at time of initial lens fitting ]
    Contact Lens User Experience CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study.
  • The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D.
  • Any cylinder power must be ≤ -0.75D.
  • The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
  • The subject must read and sign the Statement of Informed Consent.
  • The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol.

Exclusion Criteria:

  • Ocular or systemic allergies or disease which might interfere with contact lens wear.
  • Systemic disease or use of medication which might interfere with contact lens wear.
  • Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
  • Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
  • Any ocular infection.
  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  • Pregnancy or lactation.
  • Diabetes.
  • Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
  • Habitual contact lens type is toric, multifocal, or is worn as extended wear.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180985


Locations
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United States, Florida
Jacksonville, Florida, United States
Orlando, Florida, United States
United States, Virginia
Fincastle, Virginia, United States
Salem, Virginia, United States
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
More Information
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Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01180985    
Other Study ID Numbers: CR-1636BD
First Posted: August 13, 2010    Key Record Dates
Results First Posted: February 5, 2014
Last Update Posted: June 19, 2018
Last Verified: August 2017
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases