Myopia
Conditions
Brief summary
The purpose of this study is to evaluate the comparability of lens fit and lens power of a new contact lens to the lens fit and lens power of two marketed lenses.
Interventions
DEVICEgaly A Plus
galyfilcon A Plus, BC: 8.3 or 8.7
DEVICEseno A
senofilcon A, BC:8.4 or 8.8
DEVICEgaly A
galyfilcon A , BC: 8.3 or 8.7
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Must be at least 18 years of age and no more than 55 years of age. * Must sign written informed consent. * Optimal spherical equivalent distance correction must be between -1.00 and -6.00 diopters. * Have spectacle astigmatism ≤ -0.75 diopter cylinder in both eyes. * Must have visual acuity best correctable to 20/25+3 or better for each eye. * Must appear able and willing to adhere to the instructions set forth in this clinical protocol. * Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: No evidence of lid abnormality or infection; No conjunctival abnormality or infection; No clinical significant slit lamp findings, (i.e., oedema, staining, scarring, vascularization, infiltrates or abnormal opacities); No other active ocular disease. * The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of daily wear 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.
Exclusion criteria
* Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear. * Any previous eye surgery involving the anterior segment. * Pre-existing ocular disease that would preclude contact lens fitting. * Abnormal lacrimal secretions. * Keratoconus or other corneal irregularity. * Pregnancy, lactating or planning a pregnancy at the time of enrollment. * Participation in any concurrent clinical trial. * Subject's habitual contact lens type is toric or multifocal. * Require any concurrent ocular medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lens Centration Acceptance | after 15 minutes of contact lens wear | Investigator evaluated as acceptable (centered/slightly decentered) or unacceptable (substantially decentered). Number of eyes in each category will be reported by lens. This is an aggregate reporting of the lenses, combining the different base curves into a category by lens type. This is done per protocol, due to this primary outcome not being stratified by base curve. |
| Primary Gaze Lens Movement | after 15 minutes of contact lens wear | Investigator evaluated as acceptable (minimal or moderate movement) or unacceptable (insufficient or excessive movement). Percent of eyes in each category will be evaluated. |
| Fit Acceptability | after 15 minutes of contact lens wear | Investigator evaluated lens fit using a six point scale: 5-optimal...3-borderline acceptable...2-unacceptable. Percent of eyes in each category will be evaluated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| New Lens Power Fit Match to Control Lenses | after 15 minutes of contact lens wear | The lens power fit of test lenses will be compared to control lenses to determine if the power matches. Percent of eyes with exact power fit will be evaluated. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Subjects All subjects who where enrolled wore all intervention lenses throughout the course of the study. The specific lenses used include the following: senofilcon A (control) soft contact lens with 8.8 base; senofilcon A (control) soft contact lens with 8.4 base curve; galyfilcon A (control) soft contact lens with 8.7 base curve; galyfilcon A (control) soft contact lens with 8.3 base curve; galyfilcon A Plus (test) soft contact lens with 8.7 base curve; galyfilcon A Plus (test) soft contact lens with 8.3 base curve. | 41 |
| Total | 41 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 34.0 years STANDARD_DEVIATION 12.4 |
| Region of Enrollment United Kingdom | 41 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 41 |
| serious Total, serious adverse events | 0 / 41 |
Outcome results
Primary
Fit Acceptability
Investigator evaluated lens fit using a six point scale: 5-optimal...3-borderline acceptable...2-unacceptable. Percent of eyes in each category will be evaluated.
Time frame: after 15 minutes of contact lens wear
Population: Analysis was on those completed subjects who were enrolled, randomized, and assigned to a study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Galyfilcon A Plus (Test) | Fit Acceptability | Acceptable Fit | 90 percentage of eyes |
| Galyfilcon A Plus (Test) | Fit Acceptability | Unacceptable Fit | 10 percentage of eyes |
| Galyfilcon A (Control) | Fit Acceptability | Acceptable Fit | 90 percentage of eyes |
| Galyfilcon A (Control) | Fit Acceptability | Unacceptable Fit | 10 percentage of eyes |
| Senofilcon A | Fit Acceptability | Acceptable Fit | 95 percentage of eyes |
| Senofilcon A | Fit Acceptability | Unacceptable Fit | 5 percentage of eyes |
| Galyfilcon AP 8.7 BC | Fit Acceptability | Acceptable Fit | 83 percentage of eyes |
| Galyfilcon AP 8.7 BC | Fit Acceptability | Unacceptable Fit | 17 percentage of eyes |
| Galyfilcon A 8.7 BC | Fit Acceptability | Acceptable Fit | 71 percentage of eyes |
| Galyfilcon A 8.7 BC | Fit Acceptability | Unacceptable Fit | 29 percentage of eyes |
| Senofilcon A 8.8 BC | Fit Acceptability | Acceptable Fit | 80 percentage of eyes |
| Senofilcon A 8.8 BC | Fit Acceptability | Unacceptable Fit | 20 percentage of eyes |
Primary
Lens Centration Acceptance
Investigator evaluated as acceptable (centered/slightly decentered) or unacceptable (substantially decentered). Number of eyes in each category will be reported by lens. This is an aggregate reporting of the lenses, combining the different base curves into a category by lens type. This is done per protocol, due to this primary outcome not being stratified by base curve.
Time frame: after 15 minutes of contact lens wear
Population: Analysis was on those completed subjects who were enrolled, randomized, and assigned to a study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Galyfilcon A Plus (Test) | Lens Centration Acceptance | Acceptable centration | 74 eyes |
| Galyfilcon A Plus (Test) | Lens Centration Acceptance | Unacceptable centration | 8 eyes |
| Galyfilcon A (Control) | Lens Centration Acceptance | Acceptable centration | 62 eyes |
| Galyfilcon A (Control) | Lens Centration Acceptance | Unacceptable centration | 20 eyes |
| Senofilcon A | Lens Centration Acceptance | Acceptable centration | 69 eyes |
| Senofilcon A | Lens Centration Acceptance | Unacceptable centration | 13 eyes |
Primary
Primary Gaze Lens Movement
Investigator evaluated as acceptable (minimal or moderate movement) or unacceptable (insufficient or excessive movement). Percent of eyes in each category will be evaluated.
Time frame: after 15 minutes of contact lens wear
Population: Analysis was on those completed subjects who were enrolled, randomized, and assigned to a study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Galyfilcon A Plus (Test) | Primary Gaze Lens Movement | Acceptable movement | 93 percentage of eyes |
| Galyfilcon A Plus (Test) | Primary Gaze Lens Movement | Unacceptable movement | 7 percentage of eyes |
| Galyfilcon A (Control) | Primary Gaze Lens Movement | Acceptable movement | 93 percentage of eyes |
| Galyfilcon A (Control) | Primary Gaze Lens Movement | Unacceptable movement | 7 percentage of eyes |
| Senofilcon A | Primary Gaze Lens Movement | Acceptable movement | 100 percentage of eyes |
| Senofilcon A | Primary Gaze Lens Movement | Unacceptable movement | 0 percentage of eyes |
| Galyfilcon AP 8.7 BC | Primary Gaze Lens Movement | Acceptable movement | 93 percentage of eyes |
| Galyfilcon AP 8.7 BC | Primary Gaze Lens Movement | Unacceptable movement | 7 percentage of eyes |
| Galyfilcon A 8.7 BC | Primary Gaze Lens Movement | Acceptable movement | 90 percentage of eyes |
| Galyfilcon A 8.7 BC | Primary Gaze Lens Movement | Unacceptable movement | 10 percentage of eyes |
| Senofilcon A 8.8 BC | Primary Gaze Lens Movement | Acceptable movement | 98 percentage of eyes |
| Senofilcon A 8.8 BC | Primary Gaze Lens Movement | Unacceptable movement | 2 percentage of eyes |
Secondary
New Lens Power Fit Match to Control Lenses
The lens power fit of test lenses will be compared to control lenses to determine if the power matches. Percent of eyes with exact power fit will be evaluated.
Time frame: after 15 minutes of contact lens wear
Population: Analysis was on those completed subjects who were enrolled, randomized, and assigned to a study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Galyfilcon A Plus (Test) | New Lens Power Fit Match to Control Lenses | Lens Power the Same | 98 percentage of eyes |
| Galyfilcon A Plus (Test) | New Lens Power Fit Match to Control Lenses | Lens Power Not the Same | 2 percentage of eyes |
| Galyfilcon A (Control) | New Lens Power Fit Match to Control Lenses | Lens Power Not the Same | 2 percentage of eyes |
| Galyfilcon A (Control) | New Lens Power Fit Match to Control Lenses | Lens Power the Same | 98 percentage of eyes |
| Senofilcon A | New Lens Power Fit Match to Control Lenses | Lens Power the Same | 98 percentage of eyes |
| Senofilcon A | New Lens Power Fit Match to Control Lenses | Lens Power Not the Same | 2 percentage of eyes |
| Galyfilcon AP 8.7 BC | New Lens Power Fit Match to Control Lenses | Lens Power the Same | 98 percentage of eyes |
| Galyfilcon AP 8.7 BC | New Lens Power Fit Match to Control Lenses | Lens Power Not the Same | 2 percentage of eyes |