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

A Multi-site Dispensing Evaluation Comparing a New Galyfilcon A Prototype Lens With a Marketed Galyfilcon A Contact Lens

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

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: galyfilcon A prototype lens; Device: marketed galyfilcon A lens

• Study Type: Interventional
• Enrollment (Actual): 185
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Cupertino, California, United States
    • Huntington Beach, California, United States
    • Los Angeles, California, United States
    • Pismo Beach, California, United States
  • Florida
    • Jacksonville, Florida, United States
    • Orlando, Florida, United States
  • Michigan
    • East Lansing, Michigan, United States
  • Ohio
    • Columbus, Ohio, United States
  • Texas
    • Amarillo, Texas, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: ACUVUE(R) ADVANCE(TM)
Other: 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 Names: ACUVUE(R) ADVANCE(TM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Front Surface Deposits 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.	Evaluated at Day 7
Lens Front Surface Deposits 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.	Evaluated at Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Reported Overall Lens Comfort 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).	Evaluated at Day 7
Subject Reported Overall Lens Comfort 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).	Evaluated at Day 14

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2010
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: March 24, 2010
• First Submitted That Met QC Criteria: March 26, 2010
• First Posted (Estimate): March 29, 2010

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CR-1636AY