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Pilot Evaluation of a New Galyfilcon A Contact Lens Compared to a Marketed Galyfilcon A Contact Lens

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ClinicalTrials.gov Identifier: NCT01094730
Recruitment Status : Completed
First Posted : March 29, 2010
Results First Posted : November 19, 2013
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Brief Summary:
The purpose of this study is to compare lens surface characteristics and comfort between an experimental contact lens and a marketed contact lens.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-site Dispensing Evaluation Comparing a New Galyfilcon A Prototype Lens With a Marketed Galyfilcon A Contact Lens
Actual Study Start Date : February 1, 2010
Actual Primary Completion Date : April 1, 2010
Actual Study Completion Date : April 1, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
galyfilcon A prototype/marketed galyfilcon A
The galyfilcon A prototype lens worn daily for 12-16 days during the first period then the marketed galyfilcon A lens worn daily for 12-16 days during the second period.
Device: galyfilcon A prototype lens
Experimental silicone hydrogel contact lens

Device: marketed galyfilcon A lens
Marketed silicone hydrogel contact lens.
Other Name: ACUVUE(R) ADVANCE(TM)

marketed galyfilcon A/galyfilcon A prototype
The marketed galyfilcon A lens worn daily for 12-16 days during the first period then the galyfilcon A prototype lens worn daily for 12-16 days during the second period; during each period.
Device: galyfilcon A prototype lens
Experimental silicone hydrogel contact lens

Device: marketed galyfilcon A lens
Marketed silicone hydrogel contact lens.
Other Name: ACUVUE(R) ADVANCE(TM)




Primary Outcome Measures :
  1. Lens Front Surface Deposits at Day 7 [ Time Frame: Evaluated at Day 7 ]
    Deposits on the front surface of each lens were examined by the investigator after 7 days of lens wear, and graded on a 5-point scale; 0 = no deposit, 1 = 1%-5% deposits, 2 = 6%-15% deposits, 3 = 16%-25% deposits, and 4 = 25% or more deposits. The grades were categorized into binary variable: grade 0 or 1 Vs. grade 2 or higher.

  2. Lens Front Surface Deposits at Day 14 [ Time Frame: Evaluated at Day 14 ]
    Deposits on the front surface of each lens were examined by the investigator after 14 days of lens wear, and graded on a 5-point scale; 0 = 0% deposits, 1 = 1%-5% deposits, 2 = 6%-15% deposits, 3=16%-25% deposits, and 4= 25% or more deposits. The grades were categorized into binary variable: grade 0 or 1 vs. grade 2 or higher.


Secondary Outcome Measures :
  1. Subject Reported Overall Lens Comfort at Day 7 [ Time Frame: Evaluated at Day 7 ]
    The overall lens comfort was assessed at Day 7 using the Contact Lens User Experience (CLUE) questionnaire. CLUE 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. 97% of the scores fall within 0 and 120 (mean +/-3*SD).

  2. Subject Reported Overall Lens Comfort at Day 14 [ Time Frame: Evaluated at Day 14 ]
    The overall lens comfort was assessed at Day 14 using the CLUE questionnaire. CLUE 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. 97% of the scores fall within 0 and 120 (mean +/-3*SD).



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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 must be at least 18 years of age and no more than 39 years of age.
  • The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of daily wear (DW) for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study.
  • The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 9.00D.
  • 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 this 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.

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): NCT01094730


Locations
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United States, California
Cupertino, California, United States
Huntington Beach, California, United States
Los Angeles, California, United States
Pismo Beach, California, United States
United States, Florida
Jacksonville, Florida, United States
Orlando, Florida, United States
United States, Michigan
East Lansing, Michigan, United States
United States, Ohio
Columbus, Ohio, United States
United States, Texas
Amarillo, Texas, United States
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.

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Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01094730     History of Changes
Other Study ID Numbers: CR-1636AY
First Posted: March 29, 2010    Key Record Dates
Results First Posted: November 19, 2013
Last Update Posted: June 19, 2018
Last Verified: August 2017