Myopia
Conditions
Brief summary
The aim of this dispensing study is to evaluate the clinical performance of habitual wearers of enfilcon A lenses following a refit with fanfilcon A lenses over 4 weeks of daily wear.
Detailed description
This is a 30 subject, prospective, dispensing, bilateral wear, subject-masked study, reviewing the refit characteristics in a group of enfilcon A wearers switched to the fanfilcon A lens. Subject's habitual enfilcon A lenses will be evaluated at the first vist and then re-fitted with a pair of fanfilcon A lenses for 4 weeks of daily wear. After the dispensing visit, subjects will return for evaluations at 1 week, 2 weeks, and 4 weeks.
Interventions
DEVICEfanfilcon A (test)
contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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 * Has had a self-reported visual exam in the last two years * Is an adapted enfilcon A contact lens wearer (at least 2 weeks in enfilcon A lens) * Has a contact lens spherical prescription between -1.00 to - 6.00 * Has a spectacle cylinder up to 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 * Has read, understood, and signed the information consent letter. * Patient contact lens refraction should fit within the available parameters of the study lenses. * Is willing to comply with the wear schedule (at least 5 days per week, \> 8 hours/day assuming there are no contraindications for doing so). * Is willing to comply with the visit schedule
Exclusion criteria
A person will be excluded from the study if he/she: * Is not a habitual wearer of enfilcon A lenses * Has a CL (Contact Lens) prescription outside the range of the available parameters of the study lenses. * Has a spectacle cylinder ≥1.00D of cylinder in either eye. * Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day) * Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye. * Presence of clinically significant (grade 3-4) anterior segment abnormalities * Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear. * Slit lamp findings that would contraindicate contact lens wear such as: * Pathological dry eye or associated findings * 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 (past or present) * Seborrheic eczema, 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. * Is participating in any other type of eye related clinical or research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lens Fit - Centration | Baseline, 1 week, 2 weeks, and 4 weeks | Lens fit evaluation of centration for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: optimum, decentration acceptable, decentration unacceptable. |
| Lens Fit - Post-blink Movement | Baseline, 1 week, 2 weeks, and 4 weeks | Lens fit evaluation of post-blink movement for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-5 Likert scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement. |
| Lens Tightness on Push-up | Baseline, 1 week, 2 weeks, and 4 weeks | Lens fit evaluation of tightness on push-up test for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: 0%-100%, 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement. |
| Overall Fit Acceptance | Baseline, 1 week, 2 weeks, and 4 weeks | Overall fit acceptance for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimum acceptable, early review, 3=Not perfect but okay to dispense, 4=Perfect. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Satisfaction | Baseline, 1 week, 2 weeks, and 4 weeks | Subjective rating of overall satisfaction for enfilcon A habitual lens (control) at baseline and fanfilcon A lens (test) at 1 week, 2 weeks, and 4 weeks. Scale 1-4, 1=completely satisfied, 2=somewhat satisfied, 3=somewhat dissatisfied, 4=completely dissatisfied. |
| Lens Preference Overall | 1 week, 2 weeks, and 4 weeks | Subject's overall preference for one of two contact lenses. Forced choice: enfilcon A habitual lens (control) or fanfilcon A lens (test). |
| Overall Comfort | Baseline, 1 week, 2 weeks, and 4 weeks | Subjective rating of overall comfort for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=could feel, 10=cannot feel. |
| Conjunctival Staining | Baseline, 1 week, 2 weeks, and 4 weeks | Conjunctival staining for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. (Scale 0-4, 0.5 steps 0=normal, 4=severe). |
| Corneal Staining | Baseline, 1 week, 2 weeks, and 4 weeks | Corneal staining for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0.5 steps 0=normal, 4=severe. |
| Wearing Times | Baseline, 1 week, 2 weeks, and 4 weeks | Average wearing time and comfortable wearing times for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks measured by hours. |
| Dryness Overall | Baseline, 1 week, 2 weeks, and 4 weeks | Subjective rating of overall dryness for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very dry, 10=no dryness. |
| Handling | Baseline, 1 week, 2 weeks, and 4 weeks | Subjective rating of handling for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very difficult to handle, 10=very easy to handle. |
| Overall Vision Satisfaction | Baseline, 1 week, 2 weeks, and 4 weeks | Subjective rating of overall vision satisfaction for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very dissatisfied, 10=very satisfied. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Participants Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens.
fanfilcon A (test): contact lens | 34 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Overall Participants |
|---|---|
| Age, Continuous | 24.15 years STANDARD_DEVIATION 5.53 |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
Primary
Lens Fit - Centration
Lens fit evaluation of centration for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: optimum, decentration acceptable, decentration unacceptable.
Time frame: Baseline, 1 week, 2 weeks, and 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lenses: Baseline | Lens Fit - Centration | Optimum | 88 percentage of eyes |
| Habitual Lenses: Baseline | Lens Fit - Centration | Decentration unacceptable | 0 percentage of eyes |
| Habitual Lenses: Baseline | Lens Fit - Centration | Decentration acceptable | 12 percentage of eyes |
| Fanfilcon A: 1 Week | Lens Fit - Centration | Optimum | 97 percentage of eyes |
| Fanfilcon A: 1 Week | Lens Fit - Centration | Decentration unacceptable | 0 percentage of eyes |
| Fanfilcon A: 1 Week | Lens Fit - Centration | Decentration acceptable | 3 percentage of eyes |
| Fanfilcon A: 2 Weeks | Lens Fit - Centration | Decentration acceptable | 1 percentage of eyes |
| Fanfilcon A: 2 Weeks | Lens Fit - Centration | Optimum | 99 percentage of eyes |
| Fanfilcon A: 2 Weeks | Lens Fit - Centration | Decentration unacceptable | 0 percentage of eyes |
| Fanfilcon A: 4 Weeks | Lens Fit - Centration | Optimum | 100 percentage of eyes |
| Fanfilcon A: 4 Weeks | Lens Fit - Centration | Decentration unacceptable | 0 percentage of eyes |
| Fanfilcon A: 4 Weeks | Lens Fit - Centration | Decentration acceptable | 0 percentage of eyes |
Primary
Lens Fit - Post-blink Movement
Lens fit evaluation of post-blink movement for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-5 Likert scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement.
Time frame: Baseline, 1 week, 2 weeks, and 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lenses: Baseline | Lens Fit - Post-blink Movement | Minimal, but acceptable movement | 1 percentage of eyes |
| Habitual Lenses: Baseline | Lens Fit - Post-blink Movement | Excessive, unacceptable movement | 0 percentage of eyes |
| Habitual Lenses: Baseline | Lens Fit - Post-blink Movement | Optimal movement | 35 percentage of eyes |
| Habitual Lenses: Baseline | Lens Fit - Post-blink Movement | Insufficient, unacceptable movement | 0 percentage of eyes |
| Habitual Lenses: Baseline | Lens Fit - Post-blink Movement | Moderate, but acceptable movement | 64 percentage of eyes |
| Fanfilcon A: 1 Week | Lens Fit - Post-blink Movement | Insufficient, unacceptable movement | 0 percentage of eyes |
| Fanfilcon A: 1 Week | Lens Fit - Post-blink Movement | Minimal, but acceptable movement | 1 percentage of eyes |
| Fanfilcon A: 1 Week | Lens Fit - Post-blink Movement | Optimal movement | 3 percentage of eyes |
| Fanfilcon A: 1 Week | Lens Fit - Post-blink Movement | Excessive, unacceptable movement | 0 percentage of eyes |
| Fanfilcon A: 1 Week | Lens Fit - Post-blink Movement | Moderate, but acceptable movement | 96 percentage of eyes |
| Fanfilcon A: 2 Weeks | Lens Fit - Post-blink Movement | Insufficient, unacceptable movement | 0 percentage of eyes |
| Fanfilcon A: 2 Weeks | Lens Fit - Post-blink Movement | Moderate, but acceptable movement | 91 percentage of eyes |
| Fanfilcon A: 2 Weeks | Lens Fit - Post-blink Movement | Excessive, unacceptable movement | 3 percentage of eyes |
| Fanfilcon A: 2 Weeks | Lens Fit - Post-blink Movement | Minimal, but acceptable movement | 0 percentage of eyes |
| Fanfilcon A: 2 Weeks | Lens Fit - Post-blink Movement | Optimal movement | 6 percentage of eyes |
| Fanfilcon A: 4 Weeks | Lens Fit - Post-blink Movement | Minimal, but acceptable movement | 0 percentage of eyes |
| Fanfilcon A: 4 Weeks | Lens Fit - Post-blink Movement | Excessive, unacceptable movement | 3 percentage of eyes |
| Fanfilcon A: 4 Weeks | Lens Fit - Post-blink Movement | Moderate, but acceptable movement | 79 percentage of eyes |
| Fanfilcon A: 4 Weeks | Lens Fit - Post-blink Movement | Insufficient, unacceptable movement | 0 percentage of eyes |
| Fanfilcon A: 4 Weeks | Lens Fit - Post-blink Movement | Optimal movement | 18 percentage of eyes |
Primary
Lens Tightness on Push-up
Lens fit evaluation of tightness on push-up test for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: 0%-100%, 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement.
Time frame: Baseline, 1 week, 2 weeks, and 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lenses: Baseline | Lens Tightness on Push-up | 50 percentage of lens tightness | Standard Deviation 5 |
| Fanfilcon A: 1 Week | Lens Tightness on Push-up | 49 percentage of lens tightness | Standard Deviation 2 |
| Fanfilcon A: 2 Weeks | Lens Tightness on Push-up | 50 percentage of lens tightness | Standard Deviation 3 |
| Fanfilcon A: 4 Weeks | Lens Tightness on Push-up | 50 percentage of lens tightness | Standard Deviation 3 |
Primary
Overall Fit Acceptance
Overall fit acceptance for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimum acceptable, early review, 3=Not perfect but okay to dispense, 4=Perfect.
Time frame: Baseline, 1 week, 2 weeks, and 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lenses: Baseline | Overall Fit Acceptance | Minimum acceptable | 0 percentage of eyes |
| Habitual Lenses: Baseline | Overall Fit Acceptance | Borderline but unacceptable | 0 percentage of eyes |
| Habitual Lenses: Baseline | Overall Fit Acceptance | Perfect | 91 percentage of eyes |
| Habitual Lenses: Baseline | Overall Fit Acceptance | Not perfect but okay | 9 percentage of eyes |
| Habitual Lenses: Baseline | Overall Fit Acceptance | Should not be worn | 0 percentage of eyes |
| Fanfilcon A: 1 Week | Overall Fit Acceptance | Minimum acceptable | 0 percentage of eyes |
| Fanfilcon A: 1 Week | Overall Fit Acceptance | Borderline but unacceptable | 0 percentage of eyes |
| Fanfilcon A: 1 Week | Overall Fit Acceptance | Not perfect but okay | 0 percentage of eyes |
| Fanfilcon A: 1 Week | Overall Fit Acceptance | Should not be worn | 0 percentage of eyes |
| Fanfilcon A: 1 Week | Overall Fit Acceptance | Perfect | 100 percentage of eyes |
| Fanfilcon A: 2 Weeks | Overall Fit Acceptance | Should not be worn | 0 percentage of eyes |
| Fanfilcon A: 2 Weeks | Overall Fit Acceptance | Borderline but unacceptable | 0 percentage of eyes |
| Fanfilcon A: 2 Weeks | Overall Fit Acceptance | Minimum acceptable | 0 percentage of eyes |
| Fanfilcon A: 2 Weeks | Overall Fit Acceptance | Not perfect but okay | 7 percentage of eyes |
| Fanfilcon A: 2 Weeks | Overall Fit Acceptance | Perfect | 93 percentage of eyes |
| Fanfilcon A: 4 Weeks | Overall Fit Acceptance | Should not be worn | 0 percentage of eyes |
| Fanfilcon A: 4 Weeks | Overall Fit Acceptance | Perfect | 97 percentage of eyes |
| Fanfilcon A: 4 Weeks | Overall Fit Acceptance | Not perfect but okay | 3 percentage of eyes |
| Fanfilcon A: 4 Weeks | Overall Fit Acceptance | Minimum acceptable | 0 percentage of eyes |
| Fanfilcon A: 4 Weeks | Overall Fit Acceptance | Borderline but unacceptable | 0 percentage of eyes |
Secondary
Conjunctival Staining
Conjunctival staining for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. (Scale 0-4, 0.5 steps 0=normal, 4=severe).
Time frame: Baseline, 1 week, 2 weeks, and 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lenses: Baseline | Conjunctival Staining | 0.5 | 0 percentage of eyes |
| Habitual Lenses: Baseline | Conjunctival Staining | 4.0 | 0 percentage of eyes |
| Habitual Lenses: Baseline | Conjunctival Staining | 1.5 | 0 percentage of eyes |
| Habitual Lenses: Baseline | Conjunctival Staining | 1.0 | 0 percentage of eyes |
| Habitual Lenses: Baseline | Conjunctival Staining | 3.5 | 0 percentage of eyes |
| Habitual Lenses: Baseline | Conjunctival Staining | 0 | 100 percentage of eyes |
| Habitual Lenses: Baseline | Conjunctival Staining | 2.0 | 0 percentage of eyes |
| Habitual Lenses: Baseline | Conjunctival Staining | 3.0 | 0 percentage of eyes |
| Habitual Lenses: Baseline | Conjunctival Staining | 2.5 | 0 percentage of eyes |
| Fanfilcon A: 1 Week | Conjunctival Staining | 4.0 | 0 percentage of eyes |
| Fanfilcon A: 1 Week | Conjunctival Staining | 2.0 | 0 percentage of eyes |
| Fanfilcon A: 1 Week | Conjunctival Staining | 0 | 97 percentage of eyes |
| Fanfilcon A: 1 Week | Conjunctival Staining | 0.5 | 3 percentage of eyes |
| Fanfilcon A: 1 Week | Conjunctival Staining | 1.0 | 0 percentage of eyes |
| Fanfilcon A: 1 Week | Conjunctival Staining | 1.5 | 0 percentage of eyes |
| Fanfilcon A: 1 Week | Conjunctival Staining | 2.5 | 0 percentage of eyes |
| Fanfilcon A: 1 Week | Conjunctival Staining | 3.0 | 0 percentage of eyes |
| Fanfilcon A: 1 Week | Conjunctival Staining | 3.5 | 0 percentage of eyes |
| Fanfilcon A: 2 Weeks | Conjunctival Staining | 0.5 | 1 percentage of eyes |
| Fanfilcon A: 2 Weeks | Conjunctival Staining | 1.5 | 0 percentage of eyes |
| Fanfilcon A: 2 Weeks | Conjunctival Staining | 2.0 | 0 percentage of eyes |
| Fanfilcon A: 2 Weeks | Conjunctival Staining | 2.5 | 0 percentage of eyes |
| Fanfilcon A: 2 Weeks | Conjunctival Staining | 0 | 99 percentage of eyes |
| Fanfilcon A: 2 Weeks | Conjunctival Staining | 4.0 | 0 percentage of eyes |
| Fanfilcon A: 2 Weeks | Conjunctival Staining | 3.0 | 0 percentage of eyes |
| Fanfilcon A: 2 Weeks | Conjunctival Staining | 1.0 | 0 percentage of eyes |
| Fanfilcon A: 2 Weeks | Conjunctival Staining | 3.5 | 0 percentage of eyes |
| Fanfilcon A: 4 Weeks | Conjunctival Staining | 1.5 | 0 percentage of eyes |
| Fanfilcon A: 4 Weeks | Conjunctival Staining | 1.0 | 0 percentage of eyes |
| Fanfilcon A: 4 Weeks | Conjunctival Staining | 3.0 | 0 percentage of eyes |
| Fanfilcon A: 4 Weeks | Conjunctival Staining | 2.0 | 0 percentage of eyes |
| Fanfilcon A: 4 Weeks | Conjunctival Staining | 0 | 94 percentage of eyes |
| Fanfilcon A: 4 Weeks | Conjunctival Staining | 3.5 | 0 percentage of eyes |
| Fanfilcon A: 4 Weeks | Conjunctival Staining | 4.0 | 0 percentage of eyes |
| Fanfilcon A: 4 Weeks | Conjunctival Staining | 2.5 | 0 percentage of eyes |
| Fanfilcon A: 4 Weeks | Conjunctival Staining | 0.5 | 6 percentage of eyes |
Secondary
Corneal Staining
Corneal staining for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0.5 steps 0=normal, 4=severe.
Time frame: Baseline, 1 week, 2 weeks, and 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lenses: Baseline | Corneal Staining | 2.0 | 0 percentage of eyes |
| Habitual Lenses: Baseline | Corneal Staining | 1.5 | 0 percentage of eyes |
| Habitual Lenses: Baseline | Corneal Staining | 1.0 | 0 percentage of eyes |
| Habitual Lenses: Baseline | Corneal Staining | 0 | 100 percentage of eyes |
| Habitual Lenses: Baseline | Corneal Staining | 4.0 | 0 percentage of eyes |
| Habitual Lenses: Baseline | Corneal Staining | 3.0 | 0 percentage of eyes |
| Habitual Lenses: Baseline | Corneal Staining | 2.5 | 0 percentage of eyes |
| Habitual Lenses: Baseline | Corneal Staining | 0.5 | 0 percentage of eyes |
| Habitual Lenses: Baseline | Corneal Staining | 3.5 | 0 percentage of eyes |
| Fanfilcon A: 1 Week | Corneal Staining | 4.0 | 0 percentage of eyes |
| Fanfilcon A: 1 Week | Corneal Staining | 0 | 100 percentage of eyes |
| Fanfilcon A: 1 Week | Corneal Staining | 0.5 | 0 percentage of eyes |
| Fanfilcon A: 1 Week | Corneal Staining | 1.0 | 0 percentage of eyes |
| Fanfilcon A: 1 Week | Corneal Staining | 1.5 | 0 percentage of eyes |
| Fanfilcon A: 1 Week | Corneal Staining | 2.0 | 0 percentage of eyes |
| Fanfilcon A: 1 Week | Corneal Staining | 2.5 | 0 percentage of eyes |
| Fanfilcon A: 1 Week | Corneal Staining | 3.0 | 0 percentage of eyes |
| Fanfilcon A: 1 Week | Corneal Staining | 3.5 | 0 percentage of eyes |
| Fanfilcon A: 2 Weeks | Corneal Staining | 1.5 | 0 percentage of eyes |
| Fanfilcon A: 2 Weeks | Corneal Staining | 0.5 | 0 percentage of eyes |
| Fanfilcon A: 2 Weeks | Corneal Staining | 4.0 | 0 percentage of eyes |
| Fanfilcon A: 2 Weeks | Corneal Staining | 2.0 | 0 percentage of eyes |
| Fanfilcon A: 2 Weeks | Corneal Staining | 3.5 | 0 percentage of eyes |
| Fanfilcon A: 2 Weeks | Corneal Staining | 2.5 | 0 percentage of eyes |
| Fanfilcon A: 2 Weeks | Corneal Staining | 0 | 100 percentage of eyes |
| Fanfilcon A: 2 Weeks | Corneal Staining | 3.0 | 0 percentage of eyes |
| Fanfilcon A: 2 Weeks | Corneal Staining | 1.0 | 0 percentage of eyes |
| Fanfilcon A: 4 Weeks | Corneal Staining | 0.5 | 0 percentage of eyes |
| Fanfilcon A: 4 Weeks | Corneal Staining | 3.5 | 0 percentage of eyes |
| Fanfilcon A: 4 Weeks | Corneal Staining | 4.0 | 0 percentage of eyes |
| Fanfilcon A: 4 Weeks | Corneal Staining | 3.0 | 0 percentage of eyes |
| Fanfilcon A: 4 Weeks | Corneal Staining | 2.0 | 0 percentage of eyes |
| Fanfilcon A: 4 Weeks | Corneal Staining | 0 | 100 percentage of eyes |
| Fanfilcon A: 4 Weeks | Corneal Staining | 1.5 | 0 percentage of eyes |
| Fanfilcon A: 4 Weeks | Corneal Staining | 1.0 | 0 percentage of eyes |
| Fanfilcon A: 4 Weeks | Corneal Staining | 2.5 | 0 percentage of eyes |
Secondary
Dryness Overall
Subjective rating of overall dryness for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very dry, 10=no dryness.
Time frame: Baseline, 1 week, 2 weeks, and 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lenses: Baseline | Dryness Overall | 7.88 units on a scale | Standard Deviation 1.32 |
| Fanfilcon A: 1 Week | Dryness Overall | 8.82 units on a scale | Standard Deviation 1.09 |
| Fanfilcon A: 2 Weeks | Dryness Overall | 8.85 units on a scale | Standard Deviation 1.08 |
| Fanfilcon A: 4 Weeks | Dryness Overall | 8.82 units on a scale | Standard Deviation 0.94 |
Secondary
Handling
Subjective rating of handling for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very difficult to handle, 10=very easy to handle.
Time frame: Baseline, 1 week, 2 weeks, and 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lenses: Baseline | Handling | 8.85 units on a scale | Standard Deviation 1.37 |
| Fanfilcon A: 1 Week | Handling | 9.26 units on a scale | Standard Deviation 1.16 |
| Fanfilcon A: 2 Weeks | Handling | 9.59 units on a scale | Standard Deviation 0.78 |
| Fanfilcon A: 4 Weeks | Handling | 9.62 units on a scale | Standard Deviation 0.74 |
Secondary
Lens Preference Overall
Subject's overall preference for one of two contact lenses. Forced choice: enfilcon A habitual lens (control) or fanfilcon A lens (test).
Time frame: 1 week, 2 weeks, and 4 weeks
Population: One participant withdrew from the study after week 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lenses: Baseline | Lens Preference Overall | 1 week | 18 percentage of subjects |
| Habitual Lenses: Baseline | Lens Preference Overall | 2 weeks | 6 percentage of subjects |
| Habitual Lenses: Baseline | Lens Preference Overall | 4 weeks | 6 percentage of subjects |
| Fanfilcon A: 1 Week | Lens Preference Overall | 1 week | 82 percentage of subjects |
| Fanfilcon A: 1 Week | Lens Preference Overall | 2 weeks | 94 percentage of subjects |
| Fanfilcon A: 1 Week | Lens Preference Overall | 4 weeks | 94 percentage of subjects |
Secondary
Overall Comfort
Subjective rating of overall comfort for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=could feel, 10=cannot feel.
Time frame: Baseline, 1 week, 2 weeks, and 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lenses: Baseline | Overall Comfort | 8.03 units on a scale | Standard Deviation 0.97 |
| Fanfilcon A: 1 Week | Overall Comfort | 8.91 units on a scale | Standard Deviation 1.06 |
| Fanfilcon A: 2 Weeks | Overall Comfort | 8.97 units on a scale | Standard Deviation 0.83 |
| Fanfilcon A: 4 Weeks | Overall Comfort | 8.85 units on a scale | Standard Deviation 0.96 |
Secondary
Overall Satisfaction
Subjective rating of overall satisfaction for enfilcon A habitual lens (control) at baseline and fanfilcon A lens (test) at 1 week, 2 weeks, and 4 weeks. Scale 1-4, 1=completely satisfied, 2=somewhat satisfied, 3=somewhat dissatisfied, 4=completely dissatisfied.
Time frame: Baseline, 1 week, 2 weeks, and 4 weeks
Population: One participant withdrew from the study after week 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lenses: Baseline | Overall Satisfaction | Baseline - enfilcon A habitual lens (control) | 26 percentage of subjects |
| Habitual Lenses: Baseline | Overall Satisfaction | 2 weeks - fanfilcon A lens (test) | 65 percentage of subjects |
| Habitual Lenses: Baseline | Overall Satisfaction | 1 week - fanfilcon A lens (test) | 53 percentage of subjects |
| Habitual Lenses: Baseline | Overall Satisfaction | 4 weeks - fanfilcon A lens (test) | 71 percentage of subjects |
| Fanfilcon A: 1 Week | Overall Satisfaction | 2 weeks - fanfilcon A lens (test) | 35 percentage of subjects |
| Fanfilcon A: 1 Week | Overall Satisfaction | Baseline - enfilcon A habitual lens (control) | 71 percentage of subjects |
| Fanfilcon A: 1 Week | Overall Satisfaction | 4 weeks - fanfilcon A lens (test) | 29 percentage of subjects |
| Fanfilcon A: 1 Week | Overall Satisfaction | 1 week - fanfilcon A lens (test) | 47 percentage of subjects |
| Fanfilcon A: 2 Weeks | Overall Satisfaction | Baseline - enfilcon A habitual lens (control) | 3 percentage of subjects |
| Fanfilcon A: 2 Weeks | Overall Satisfaction | 4 weeks - fanfilcon A lens (test) | 0 percentage of subjects |
| Fanfilcon A: 2 Weeks | Overall Satisfaction | 1 week - fanfilcon A lens (test) | 0 percentage of subjects |
| Fanfilcon A: 2 Weeks | Overall Satisfaction | 2 weeks - fanfilcon A lens (test) | 0 percentage of subjects |
| Fanfilcon A: 4 Weeks | Overall Satisfaction | 1 week - fanfilcon A lens (test) | 0 percentage of subjects |
| Fanfilcon A: 4 Weeks | Overall Satisfaction | 4 weeks - fanfilcon A lens (test) | 0 percentage of subjects |
| Fanfilcon A: 4 Weeks | Overall Satisfaction | Baseline - enfilcon A habitual lens (control) | 0 percentage of subjects |
| Fanfilcon A: 4 Weeks | Overall Satisfaction | 2 weeks - fanfilcon A lens (test) | 0 percentage of subjects |
Secondary
Overall Vision Satisfaction
Subjective rating of overall vision satisfaction for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very dissatisfied, 10=very satisfied.
Time frame: Baseline, 1 week, 2 weeks, and 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lenses: Baseline | Overall Vision Satisfaction | 9.24 units on a scale | Standard Deviation 0.82 |
| Fanfilcon A: 1 Week | Overall Vision Satisfaction | 9.56 units on a scale | Standard Deviation 0.79 |
| Fanfilcon A: 2 Weeks | Overall Vision Satisfaction | 9.79 units on a scale | Standard Deviation 0.41 |
| Fanfilcon A: 4 Weeks | Overall Vision Satisfaction | 9.74 units on a scale | Standard Deviation 0.51 |
Secondary
Wearing Times
Average wearing time and comfortable wearing times for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks measured by hours.
Time frame: Baseline, 1 week, 2 weeks, and 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Habitual Lenses: Baseline | Wearing Times | Average wearing time | 8.79 hours | Standard Deviation 1.67 |
| Habitual Lenses: Baseline | Wearing Times | Comfortable wearing time | 7.65 hours | Standard Deviation 1.5 |
| Fanfilcon A: 1 Week | Wearing Times | Comfortable wearing time | 8.97 hours | Standard Deviation 2.44 |
| Fanfilcon A: 1 Week | Wearing Times | Average wearing time | 9.82 hours | Standard Deviation 2.11 |
| Fanfilcon A: 2 Weeks | Wearing Times | Average wearing time | 9.65 hours | Standard Deviation 1.69 |
| Fanfilcon A: 2 Weeks | Wearing Times | Comfortable wearing time | 8.91 hours | Standard Deviation 1.73 |
| Fanfilcon A: 4 Weeks | Wearing Times | Average wearing time | 9.85 hours | Standard Deviation 1.56 |
| Fanfilcon A: 4 Weeks | Wearing Times | Comfortable wearing time | 8.97 hours | Standard Deviation 1.4 |