Myopia
Conditions
Brief summary
Prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, 1 month dispensing study (2 weeks each lens pair)
Detailed description
The aim of this study is to determine the clinical performance of fanfilcon A in comparison to senofilcon A sphere contact lenses.
Interventions
DEVICEfanfilcon A
contact lens
DEVICEsenofilcon A
contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
A person is eligible for inclusion in the study if he/she: * Is between 18 and 40 years of age (inclusive) * Has read, understood and signed the information consent letter * Has had a self-reported eye exam in the last two years * Is a spherical soft contact lens wearer * Has a contact lens prescription that fits within the available parameters of the study lenses * Has a spectacle cylinder no greater than 0.75D (Diopters) in each eye * Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye * Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses * Has clear corneas and no active ocular disease * Is willing and anticipated to be able to comply with the wear schedule (8 hours per day; 5 days a week of lens wear) * Is willing and able to follow instructions and maintain the appointment schedule
Exclusion criteria
A person will be excluded from the study if he/she: * Has a history of not achieving comfortable CL (Contact Lens) wear (defined as 5 days per week; \>8 hours/day) * Is currently wearing senofilcon C (2 weeks lens), senofilcon A 1-Day, senofilcon C (monthly lens) or enfilcon A contact lenses * Is habitually using rewetting/ lubricating eye drops more than once per day * Presents with clinically significant anterior segment abnormalities * Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear * Presents with slit lamp findings that would contraindicate contact lens wear such as: * Pathological dry eye or associated findings * Significant pterygium, pinguecula, or corneal scars within the visual axis * Neovascularization \> 0.75 mm in from of the limbus * Giant papillary conjunctivitis (GCP) worse than grade 1 * Anterior uveitis or iritis (or history in past year) * Seborrheic eczema of eyelid region, Seborrheic conjunctivitis * History of corneal ulcers or fungal infections * Poor personal hygiene * Has a known history of corneal hypoesthesia (reduced corneal sensitivity) * Has aphakia, keratoconus or a highly irregular cornea * Has presbyopia or has dependence on spectacles for near work over the contact lenses * Has undergone corneal refractive surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Comfort | 2 weeks | Subjective assessment for comfort is assessed. Scale 0-10, 0=painful, 10=can't feel |
| Overall Dryness | 2 weeks | Subjective ratings for dryness is assessed on a scale of 0-10, 0=extremely dry, 10=no dryness |
| Vision Quality | 2 weeks | Subjective ratings of vision quality is assessed on a scale 0-10, 0=not sharp/not clear, 10=sharp/clear |
| Lens Handling | 2 weeks | Subjective ratings of lens handling - insertion and removal - is assessed using scale 0-10, 0=difficult to handle, 10=very easy to handle |
| Vision Satisfaction | 2 weeks | Subjective ratings of vision satisfaction is assessed on a scale 0-10, 0=completely dissatisfied, 10=completely satisfied. |
| Lens Centration | 2 weeks | Lens centration will be recorded by degree and direction in the primary position. (Optimum, decentration acceptable, decentration unacceptable). |
| Conjunctival Staining | 2 weeks | Assessed using slit lamp with blue light and sodium fluorescein, low medium magnification. 0=None, no staining present 1. Very slight 2. Slight 3. Moderate 4. Severe |
| Smoothness | 2 weeks | Subjective ratings for lens sensation of smoothness is assessed on a scale 0-10, 0=not smooth at all, 10=totally smooth |
| Clean Feeling | 2 weeks | Subjective ratings for lens clean feeling is assessed on a scale 0-10, 0=not clean at all, 10=lenses feel perfectly clean |
| Lens Hydrated | 2 weeks | Subjective ratings for lens sensation is assessed on a scale 0-10, 0=totally dehydrated, 10=totally hydrated |
| Lens Wettability | 2 weeks | Subjective ratings for lens wettability is assessed on a scale 0-10, 0=non-wettable, 10=highly wettable |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fanfilcon A First Then Senofilcon A Participants are randomized to wear fanfilcon A for two weeks then senofilcon A | 30 |
| Senofilcon A First Then Fanfilcon A Participants are randomized to wear senofilcon A for two weeks then fanfilcon A | 34 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Lens 1 | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Fanfilcon A First Then Senofilcon A | Senofilcon A First Then Fanfilcon A | Total |
|---|---|---|---|
| Age, Continuous | 31.6 years STANDARD_DEVIATION 6.1 | 29.6 years STANDARD_DEVIATION 5.6 | 30.5 years STANDARD_DEVIATION 5.9 |
| Sex: Female, Male Female | 24 Participants | 28 Participants | 52 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 0 / 63 |
| other Total, other adverse events | 0 / 63 | 0 / 63 |
| serious Total, serious adverse events | 0 / 63 | 0 / 63 |
Outcome results
Primary
Clean Feeling
Subjective ratings for lens clean feeling is assessed on a scale 0-10, 0=not clean at all, 10=lenses feel perfectly clean
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fanfilcon A | Clean Feeling | 8.7 units on a scale | Standard Deviation 1.7 |
| Senofilcon A | Clean Feeling | 8.9 units on a scale | Standard Deviation 1.4 |
Primary
Conjunctival Staining
Assessed using slit lamp with blue light and sodium fluorescein, low medium magnification. 0=None, no staining present 1. Very slight 2. Slight 3. Moderate 4. Severe
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fanfilcon A | Conjunctival Staining | 0.4 units on a scale | Standard Deviation 0.7 |
| Senofilcon A | Conjunctival Staining | 0.6 units on a scale | Standard Deviation 0.8 |
Primary
Lens Centration
Lens centration will be recorded by degree and direction in the primary position. (Optimum, decentration acceptable, decentration unacceptable).
Time frame: 2 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fanfilcon A | Lens Centration | Optimum | 62 Participants |
| Fanfilcon A | Lens Centration | Acceptable | 1 Participants |
| Fanfilcon A | Lens Centration | Unacceptable | 0 Participants |
| Senofilcon A | Lens Centration | Optimum | 63 Participants |
| Senofilcon A | Lens Centration | Acceptable | 0 Participants |
| Senofilcon A | Lens Centration | Unacceptable | 0 Participants |
Primary
Lens Handling
Subjective ratings of lens handling - insertion and removal - is assessed using scale 0-10, 0=difficult to handle, 10=very easy to handle
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fanfilcon A | Lens Handling | Insertion | 9.3 units on a scale | Standard Deviation 1.3 |
| Fanfilcon A | Lens Handling | Removal | 8.4 units on a scale | Standard Deviation 2 |
| Senofilcon A | Lens Handling | Insertion | 9.4 units on a scale | Standard Deviation 1.2 |
| Senofilcon A | Lens Handling | Removal | 9.3 units on a scale | Standard Deviation 1.3 |
Primary
Lens Hydrated
Subjective ratings for lens sensation is assessed on a scale 0-10, 0=totally dehydrated, 10=totally hydrated
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fanfilcon A | Lens Hydrated | 8.3 units on a scale | Standard Deviation 2 |
| Senofilcon A | Lens Hydrated | 8.5 units on a scale | Standard Deviation 1.6 |
Primary
Lens Wettability
Subjective ratings for lens wettability is assessed on a scale 0-10, 0=non-wettable, 10=highly wettable
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fanfilcon A | Lens Wettability | 8.4 units on a scale | Standard Deviation 1.9 |
| Senofilcon A | Lens Wettability | 8.5 units on a scale | Standard Deviation 1.6 |
Primary
Overall Comfort
Subjective assessment for comfort is assessed. Scale 0-10, 0=painful, 10=can't feel
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fanfilcon A | Overall Comfort | 8.4 units on a scale | Standard Deviation 1.9 |
| Senofilcon A | Overall Comfort | 8.7 units on a scale | Standard Deviation 1.5 |
Primary
Overall Dryness
Subjective ratings for dryness is assessed on a scale of 0-10, 0=extremely dry, 10=no dryness
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fanfilcon A | Overall Dryness | 8.2 units on a scale | Standard Deviation 1.9 |
| Senofilcon A | Overall Dryness | 8.2 units on a scale | Standard Deviation 1.9 |
Primary
Smoothness
Subjective ratings for lens sensation of smoothness is assessed on a scale 0-10, 0=not smooth at all, 10=totally smooth
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fanfilcon A | Smoothness | 8.7 units on a scale | Standard Deviation 1.7 |
| Senofilcon A | Smoothness | 9.1 units on a scale | Standard Deviation 1.4 |
Primary
Vision Quality
Subjective ratings of vision quality is assessed on a scale 0-10, 0=not sharp/not clear, 10=sharp/clear
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fanfilcon A | Vision Quality | 9.0 units on a scale | Standard Deviation 1.5 |
| Senofilcon A | Vision Quality | 8.9 units on a scale | Standard Deviation 1.6 |
Primary
Vision Satisfaction
Subjective ratings of vision satisfaction is assessed on a scale 0-10, 0=completely dissatisfied, 10=completely satisfied.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fanfilcon A | Vision Satisfaction | 8.7 units on a scale | Standard Deviation 2.1 |
| Senofilcon A | Vision Satisfaction | 8.6 units on a scale | Standard Deviation 1.7 |