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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States
    • Orlando, Florida, United States
  • Virginia
    • Fincastle, Virginia, United States
    • Salem, Virginia, 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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: Biofinity® contact lens
Other: 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 Names: Biofinity® contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity Monocular	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.	after 7 +/- 1 days of lens wear
Visual Acuity Binocular	Snellen binocular visual acuity measurement	after 7 +/- 1 days of lens wear
Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire.	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.	after 7 +/-1 days of lens wear
Subjective Assessment of Quality of Vision Using the Contact Lens User Experience(CLUE)TM Questionnaire.	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.	after 7 +/- 1 days of lens wear

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Limbal Redness	Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.	after 7 days of lens wear
Bulbar Redness	Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.	after 7 days of lens wear
Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire.	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.	10 minutes after lens insertion at time of initial lens fitting

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2010
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: August 11, 2010
• First Submitted That Met QC Criteria: August 12, 2010
• First Posted (Estimate): August 13, 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-1636BD