Non-Dispensing Evaluation of an Investigational Galyfilcon A Soft Contact Lens
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Comparison of Lens Fit Characteristics
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
GalyfilconHL/Galyfilcon8.7/Galyfilcon8.3
Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)
Intervention: Galyfilcon A Habitual Lens (Device)
GalyfilconHL/Galyfilcon8.7/Galyfilcon8.3
Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)
Intervention: Galyfilcon A 8.7 BC (Investigational) (Device)
GalyfilconHL/Galyfilcon8.7/Galyfilcon8.3
Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)
Intervention: Galyfilcon A 8.3 BC (Investigational) (Device)
Galyfilcon8.7/Galyfilcon8.3/GalyfilconHL
Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)
Intervention: Galyfilcon A Habitual Lens (Device)
Galyfilcon8.7/Galyfilcon8.3/GalyfilconHL
Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)
Intervention: Galyfilcon A 8.7 BC (Investigational) (Device)
Galyfilcon8.7/Galyfilcon8.3/GalyfilconHL
Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)
Intervention: Galyfilcon A 8.3 BC (Investigational) (Device)
GalyfilconHL/Galyfilcon8.3/Galyfilcon8.7
Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)
Intervention: Galyfilcon A Habitual Lens (Device)
GalyfilconHL/Galyfilcon8.3/Galyfilcon8.7
Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)
Intervention: Galyfilcon A 8.7 BC (Investigational) (Device)
GalyfilconHL/Galyfilcon8.3/Galyfilcon8.7
Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)
Intervention: Galyfilcon A 8.3 BC (Investigational) (Device)
Galyfilcon 8.7/Galyfilcon HL/Galyfilcon 8.3
Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator) /Galyfilcon A 8.3 BC (Experimental)
Intervention: Galyfilcon A Habitual Lens (Device)
Galyfilcon 8.7/Galyfilcon HL/Galyfilcon 8.3
Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator) /Galyfilcon A 8.3 BC (Experimental)
Intervention: Galyfilcon A 8.7 BC (Investigational) (Device)
Galyfilcon 8.7/Galyfilcon HL/Galyfilcon 8.3
Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator) /Galyfilcon A 8.3 BC (Experimental)
Intervention: Galyfilcon A 8.3 BC (Investigational) (Device)
Galyfilcon8.3/GalyfilconHL/Galyfilcon8.7
Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)
Intervention: Galyfilcon A Habitual Lens (Device)
Galyfilcon8.3/GalyfilconHL/Galyfilcon8.7
Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)
Intervention: Galyfilcon A 8.7 BC (Investigational) (Device)
Galyfilcon8.3/GalyfilconHL/Galyfilcon8.7
Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)
Intervention: Galyfilcon A 8.3 BC (Investigational) (Device)
Galyfilcon8.3/Galyfilcon8.7/GalyfilconHL
Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)
Intervention: Galyfilcon A Habitual Lens (Device)
Galyfilcon8.3/Galyfilcon8.7/GalyfilconHL
Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)
Intervention: Galyfilcon A 8.7 BC (Investigational) (Device)
Galyfilcon8.3/Galyfilcon8.7/GalyfilconHL
Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)
Intervention: Galyfilcon A 8.3 BC (Investigational) (Device)
Outcomes
Primary Outcomes
Comparison of Lens Fit Characteristics
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Secondary Outcomes
No secondary outcomes reported