Myopia
Conditions
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.
Interventions
DEVICEGalyfilcon A Habitual Lens
Comparison of three soft contact lens designs.
DEVICEGalyfilcon A 8.7 BC (Investigational)
Comparison of three soft contact lens designs.
DEVICEGalyfilcon A 8.3 BC (Investigational)
Comparison of three soft contact lens designs
Sponsors
Coles-Brennan Pty Ltd
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Australia
Outcome results
None listed