Non-Dispensing Evaluation of an Investigational Galyfilcon A Soft Contact Lens

Not Applicable

Completed

Conditions: Myopia

Interventions: Device: Galyfilcon A Habitual Lens
Device: Galyfilcon A 8.7 BC (Investigational)
Device: Galyfilcon A 8.3 BC (Investigational)

Registration Number: NCT01054807

Lead Sponsor: Johnson & Johnson Vision Care, Inc.

Brief Summary: The purpose of this investigation is to compare the fit characteristics and vision attributes of an investigational Galyfilcon A contact lens and an approved Galyfilcon A contact lens.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 32

Inclusion Criteria

Be of legal age (i.e., at least 18 years old)
Sign a written informed consent
Have contact lens distance sphere requirement in the range -1.00D to -6.00D
Have spectacle astigmatism <1.25D in each eye
Currently wear ACUVUE® ADVANCE™ (for at least 6 months) with documentation of current prescription.
Have normal eyes with no evidence of abnormality or disease.

Exclusion Criteria

Required concurrent ocular medication
Any systemic illness which would contra-indicate lens wear or the medical treatment of which would affect vision or successful lens wear.
Eye injury or surgery within eight weeks immediately prior to enrollment for this study.
Abnormal lacrimal secretions
Pre-existing ocular irritation that would preclude contact lens fitting.
Keratoconus or other corneal irregularity.
Pregnancy, lactating or planning a pregnancy at the time of enrolment.
Participation in any concurrent clinical trial
Known allergy to silver, silver ions, or silver containing compounds.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GalyfilconHL/Galyfilcon8.7/Galyfilcon8.3	Galyfilcon A 8.7 BC (Investigational)	Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)
Galyfilcon8.7/Galyfilcon8.3/GalyfilconHL	Galyfilcon A 8.3 BC (Investigational)	Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)
Galyfilcon 8.7/Galyfilcon HL/Galyfilcon 8.3	Galyfilcon A 8.7 BC (Investigational)	Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator) /Galyfilcon A 8.3 BC (Experimental)
Galyfilcon8.3/GalyfilconHL/Galyfilcon8.7	Galyfilcon A 8.7 BC (Investigational)	Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)
GalyfilconHL/Galyfilcon8.7/Galyfilcon8.3	Galyfilcon A Habitual Lens	Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)
GalyfilconHL/Galyfilcon8.7/Galyfilcon8.3	Galyfilcon A 8.3 BC (Investigational)	Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)
Galyfilcon8.7/Galyfilcon8.3/GalyfilconHL	Galyfilcon A Habitual Lens	Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)
Galyfilcon8.7/Galyfilcon8.3/GalyfilconHL	Galyfilcon A 8.7 BC (Investigational)	Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)
GalyfilconHL/Galyfilcon8.3/Galyfilcon8.7	Galyfilcon A Habitual Lens	Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)
Galyfilcon8.3/GalyfilconHL/Galyfilcon8.7	Galyfilcon A Habitual Lens	Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)
Galyfilcon8.3/Galyfilcon8.7/GalyfilconHL	Galyfilcon A 8.7 BC (Investigational)	Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)
GalyfilconHL/Galyfilcon8.3/Galyfilcon8.7	Galyfilcon A 8.7 BC (Investigational)	Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)
GalyfilconHL/Galyfilcon8.3/Galyfilcon8.7	Galyfilcon A 8.3 BC (Investigational)	Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)
Galyfilcon 8.7/Galyfilcon HL/Galyfilcon 8.3	Galyfilcon A Habitual Lens	Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator) /Galyfilcon A 8.3 BC (Experimental)
Galyfilcon 8.7/Galyfilcon HL/Galyfilcon 8.3	Galyfilcon A 8.3 BC (Investigational)	Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator) /Galyfilcon A 8.3 BC (Experimental)
Galyfilcon8.3/GalyfilconHL/Galyfilcon8.7	Galyfilcon A 8.3 BC (Investigational)	Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)
Galyfilcon8.3/Galyfilcon8.7/GalyfilconHL	Galyfilcon A 8.3 BC (Investigational)	Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)
Galyfilcon8.3/Galyfilcon8.7/GalyfilconHL	Galyfilcon A Habitual Lens	Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)

Primary Outcome Measures

Name	Time	Method
Comparison of Lens Fit Characteristics	Approximately 40 minutes of wear time	At the screening visit, the following baseline measurements will be taken of the subject's habitual contact lenses (Control): * Visual Acuity (logMar) * Over-refraction with Visual Acuity * Fit acceptability (acceptable/non-acceptable)
Evaluation of Inter-Changeability	Approximately 40 minutes of wear time	In a bilateral fashion, the subject will wear Test/Control lens according to a pre-designed randomization schedule. Immediately upon insertion, the following variables will be assessed: * Ease of handling of the lenses- by Investigator * Comfort on insertion After 30-40 minutes of settling time the following variables will be collected: * Subjective comfort after settling * Visual Acuity (logMar) * Corneal coverage (Y/N) * Post-blink movement (mm) * Version Lag (mm) * Tightness on push-up (0-100 scale) * Overall fit acceptance (0-5 scale)
Determination of fit or Vision Differences	Approximately 40 minutes of wear time	In a bilateral fashion, the subject will wear Test/Control lens according to a pre-designed randomization schedule. Immediately upon insertion, the following variables will be assessed: * Ease of handling of the lenses- by Investigator * Comfort on insertion After 30-40 minutes of settling time the following variables will be collected: * Subjective comfort after settling * Visual Acuity (logMar) * Corneal coverage (Y/N) * Post-blink movement (mm) * Version Lag (mm) * Tightness on push-up (0-100 scale) * Overall fit acceptance (0-5 scale)