Myopia
Conditions
Brief summary
This study is a masked, multi-center, daily wear, monthly replacement, bilateral, randomized, lens blocked (subjects remain in the same lens brand throughout the study) concurrent control study enrolling up to 90 subjects with a study duration of approximately three months. Subjects will be randomized into the study contact lenses in a two to one (2:1) ratio of fanfilcon A lens (test) to enfilcon A lens (control).
Detailed description
Subjects will be randomized into the study contact lenses in a two to one (2:1) ratio of fanfilcon A lens (test) to enfilcon A lens (control). This should result in a study population of approximately 60 test subjects and 30 control subjects.
Interventions
silicone hydrogel lens
silicone hydrogel lens
Sponsors
Study design
Eligibility
Inclusion criteria
* Be at least 18 years of age as of the date of evaluation for the study. * Have: * Read the Informed Consent * Been given an explanation of the Informed Consent * Indicated understanding of the Informed Consent * Signed the Informed Consent document. * Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments. * Be an adapted, current full-time silicone hydrogel or soft contact lens wearer. An adapted full-time wearer is defined as wearing contact lenses at least 5 days per week for at least 8 hours per day for at least one month prior to participation in the study. * Possess or obtain prior to dispensing, wearable and visually functional (20/40 or better) eyeglasses. * Be in good general health, based on his/her knowledge. * Require spectacle lens powers between -0.50 and -8.00 diopters sphere with no more than 1.50 diopter of refractive astigmatism and be willing to wear contact lenses in both eyes. * Have manifest refraction Snellen visual acuities (VA) equal to or better than20/25 in each eye. * To be eligible for lens dispensing, the subject must achieve 20/30 VA or better in each eye with the study lens and the investigator must judge the fit as acceptable or optimal.
Exclusion criteria
* Wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes for the duration of the study. Note: Subjects may not wear lenses in a monovision modality at any time during the study as it will interfere with the visual acuity analysis. * Poor personal hygiene. * Any active participation in another clinical trial during this trial or within 30 days prior to this study. * To the best of the subject's knowledge, she is currently pregnant, is lactating or is planning a pregnancy within the next 3 months. * A member, relative or household member of the investigator or of the investigational office staff. * Has a known sensitivity to the ingredients used in the Multi-Purpose Disinfection Lens Care System (MPS) approved for use in the study and is unable or unwilling to use the alternate care system. * Previous refractive surgery; or current or previous orthokeratology treatment. * Is aphakic or pseudophakic. * Ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, scleroderma, keratoconus or uncontrolled diabetes. * The need for topical ocular medications or any systemic medication which might interfere with contact lens wear or require the lenses to be removed during the day. * The presence of clinically significant (grade 2, 3 or 4) anterior segment abnormalities; or the presence of any inflammations such as iritis; or any infection of the eye, lids, or associated structures. * A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, iritis, bacterial or fungal infections. * A history of papillary conjunctivitis that has interfered with contact lens wear. * Slit lamp findings that would contraindicate contact lens wear, including but not limited to: * Pathological dry eye or associated dry eye symptoms with decreased tear levels and punctuate staining \> Grade 2 * Pterygium * Corneal scars within the visual axis * Neovascularization or ghost vessels \> 1.0 mm in from the limbus * Giant papillary conjunctivitis (GPC) of \> Grade 2 * Anterior uveitis or iritis * Seborrheic eczema, seborrheic conjunctivitis or blepharitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Wearing Time - Enfilcon A Lens (Control) | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Average lens wearing time for enfilcon A lens (control) measured in hours. |
| Bulbar Hyperemia - Fanfilcon A Lens (Test) | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Bulbar hyperemia is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe |
| Palpebral Conjunctiva - Fanfilcon A Lens (Test) | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Palpebral conjunctiva is assessed for fanfilcon A lens (test). Grading scale: Absent/present |
| Palpebral Conjunctiva - Enfilcon A Lens (Control) | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Palpebral conjunctiva is assessed for enfilcon A lens (control). Grading scale: absent/present |
| Visual Acuity - Fanfilcon A Lens (Test) | Week 1, Week 2, Month 1, Month 2, Month 3 | Visual acuity is assessed for fanfilcon A lens (test) using Snellen chart. |
| Visual Acuity - Enfilcon A Lens (Control) | Week 1, Week 2, Month 1, Month 2, Month 3 | Visual acuity is assessed for enfilcon A lens (control) using Snellen chart. |
| Average Wearing Time - Fanfilcon A Lens (Test) | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Average lens wearing time for fanfilcon A lens (test) measured in hours. |
| Bulbar Hyperemia - Enfilcon A Lens (Control) | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Bulbar hyperemia is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe |
| Epithelial Edema - Fanfilcon A Lens (Test) | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Epithelial edema is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe |
| Epithelial Edema - Enfilcon A Lens (Control) | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Epithelial edema is assessed for enfilcon A lens (control). Grading scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe |
| Stromal Edema - Fanfilcon A Lens (Test) | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Stromal edema is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe |
| Stromal Edema - Enfilcon A Lens (Control) | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Stromal edema is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe |
| Corneal Infiltrates - Fanfilcon A Lens (Test) | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Corneal infiltrates is assessed for fanfilcon A lens (test). Grading scale: Absent/present |
| Corneal Infiltrates - Enfilcon A Lens (Control) | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Corneal infiltrates is assessed for enfilcon A lens (control). Grading scale: absent/present |
| Corneal Vascularization - Fanfilcon A Lens (Test) | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Corneal vascularization is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe |
| Corneal Vascularization - Enfilcon A Lens (Control) | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Corneal vascularization is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe |
| Corneal Staining - Fanfilcon A Lens (Test) | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Corneal staining with fluorescein is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe; Grading regions: S - Superior, T - Temporal, C - Central, N - Nasal, I - Inferior; |
| Corneal Staining - Enfilcon A Lens (Control) | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Corneal staining with fluorescein is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe; Grading regions: S - Superior, T - Temporal, C - Central, N - Nasal, I - Inferior; |
| Limbal Hyperemia - Fanfilcon A Lens (Test) | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Limbal hyperemia is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe |
| Limbal Hyperemia - Enfilcon A Lens (Control) | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Limbal hyperemia is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comfort - Enfilcon A Lens (Control) | Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months follow-up | Enfilcon A lens (control) are assessed regarding comfort for the following: comfort upon insertion (CUI), comfort during the day (CDD), end of the day comfort (EDC), overall comfort (OC), and comfort at visit (CV). Subjects were asked to rate comfort from 0-5 (0=excellent, 1=very comfortable, 2=comfortable, 3=slightly uncomfortable, 4=very uncomfortable, or 5=causes pain). |
| Overall Vision Quality - Fanfilcon A Lens (Test) | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Overall vision quality (OVQ) and vision at night (VAN) is assessed at the specific time points. Subjects were asked to rate vision from 0-5, (0=excellent, 1=very good, 2=good, 3=poor, 4=very poor, 5= unacceptable). |
| Overall Vision Quality - Enfilcon A Lens (Control) | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Overall vision quality (OVQ) and vision at night (VAN) is assessed at the specific time points. Subjects were asked to rate vision from 0-5, (0=excellent, 1=very good, 2=good, 3=poor, 4=very poor, 5= unacceptable). |
| Ease of Insertion and Removal - Fanfilcon A Lens (Test) | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Ease of Insertion (EOI) and removal (EOR) was assessed. Subjects were asked to rate ease of insertion and removal on scale 0-5 (0=excellent, 1=very good, 2=good, 3=poor, 4=very poor, or 5=unmanageable. |
| Ease of Insertion and Removal - Enfilcon A Lens (Control) | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Ease of Insertion (EOI) and removal (EOR) was assessed. Subjects were asked to rate ease of insertion and removal on scale 0-5 (0=excellent, 1=very good, 2=good, 3=poor, 4=very poor, or 5=unmanageable. |
| Comfort - Fanfilcon A Lens (Test) | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | Fanfilcon A lens (test) are assessed regarding comfort for the following: comfort upon insertion (CUI), comfort during the day (CDD), end of the day comfort (EDC), overall comfort (OC), and comfort at visit (CV). Subjects were asked to rate comfort from 0-5 (0=excellent, 1=very comfortable, 2=comfortable, 3=slightly uncomfortable, 4=very uncomfortable, or 5=causes pain). |
Countries
United States
Participant flow
Recruitment details
Subjects were randomized to the study lenses based on a 2 to 1 ratio within each investigational site and across the entire study using randomization tables.
Pre-assignment details
Two (2) subjects were ineligible and were not randomized and exited the study. This left 90 subjects randomized into the test and control products.
Participants by arm
| Arm | Count |
|---|---|
| Fanfilcon A (Test) Subjects will be randomized to wear fanfilcon A lens (test) for one month of daily wear during the study.
fanfilcon A (test): silicone hydrogel lens | 60 |
| Enfilcon A (Control) Subjects will be randomized to wear enfilcon A lens (control) for one month of daily wear during the study.
enfilcon A (control): silicone hydrogel lens | 30 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Month 1 | Lens Discomfort | 1 | 0 |
| Month 2 | Lost to Follow-up | 1 | 0 |
| Month 2 | Withdrawal by Subject | 3 | 0 |
| Week 2 | Adverse Event | 0 | 1 |
| Week 2 | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Fanfilcon A (Test) | Enfilcon A (Control) | Total |
|---|---|---|---|
| Age, Continuous | 34.72 years STANDARD_DEVIATION 10.32 | 33.67 years STANDARD_DEVIATION 10.162 | 34.37 years STANDARD_DEVIATION 10.223 |
| Sex: Female, Male Female | 49 Participants | 23 Participants | 72 Participants |
| Sex: Female, Male Male | 11 Participants | 7 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 30 |
| other Total, other adverse events | 0 / 60 | 0 / 30 |
| serious Total, serious adverse events | 0 / 60 | 0 / 30 |
Outcome results
Average Wearing Time - Enfilcon A Lens (Control)
Average lens wearing time for enfilcon A lens (control) measured in hours.
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Population: All sites, control completed subjects' eyes. Three subjects data was not collected during Week 1 visit. One subject data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Average Wearing Time - Enfilcon A Lens (Control) | 13.81 hours | Standard Deviation 2.95 |
| Week 1 | Average Wearing Time - Enfilcon A Lens (Control) | 13.67 hours | Standard Deviation 2.58 |
| Week 2 | Average Wearing Time - Enfilcon A Lens (Control) | 13.41 hours | Standard Deviation 2.28 |
| Month 1 | Average Wearing Time - Enfilcon A Lens (Control) | 13.52 hours | Standard Deviation 2.11 |
| Month 2 | Average Wearing Time - Enfilcon A Lens (Control) | 13.20 hours | Standard Deviation 2.5 |
| Month 3 | Average Wearing Time - Enfilcon A Lens (Control) | 13.62 hours | Standard Deviation 2.35 |
| Unscheduled | Average Wearing Time - Enfilcon A Lens (Control) | 12.67 hours | Standard Deviation 1.16 |
Average Wearing Time - Fanfilcon A Lens (Test)
Average lens wearing time for fanfilcon A lens (test) measured in hours.
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Population: All sites, test subjects' completed eyes. One subject data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Average Wearing Time - Fanfilcon A Lens (Test) | 14.17 hours | Standard Deviation 4.24 |
| Week 1 | Average Wearing Time - Fanfilcon A Lens (Test) | 13.25 hours | Standard Deviation 2.56 |
| Week 2 | Average Wearing Time - Fanfilcon A Lens (Test) | 13.08 hours | Standard Deviation 2.23 |
| Month 1 | Average Wearing Time - Fanfilcon A Lens (Test) | 13.18 hours | Standard Deviation 2.59 |
| Month 2 | Average Wearing Time - Fanfilcon A Lens (Test) | 13.21 hours | Standard Deviation 2.41 |
| Month 3 | Average Wearing Time - Fanfilcon A Lens (Test) | 13.13 hours | Standard Deviation 2.61 |
| Unscheduled | Average Wearing Time - Fanfilcon A Lens (Test) | 16.50 hours | Standard Deviation 0.71 |
Bulbar Hyperemia - Enfilcon A Lens (Control)
Bulbar hyperemia is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Population: All sites, control completed subjects' eyes. Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Baseline | Bulbar Hyperemia - Enfilcon A Lens (Control) | None | 65.5 percentage of eyes |
| Baseline | Bulbar Hyperemia - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
| Baseline | Bulbar Hyperemia - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Baseline | Bulbar Hyperemia - Enfilcon A Lens (Control) | Mild | 0.0 percentage of eyes |
| Baseline | Bulbar Hyperemia - Enfilcon A Lens (Control) | Trace | 34.5 percentage of eyes |
| Week 1 | Bulbar Hyperemia - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
| Week 1 | Bulbar Hyperemia - Enfilcon A Lens (Control) | None | 61.5 percentage of eyes |
| Week 1 | Bulbar Hyperemia - Enfilcon A Lens (Control) | Trace | 38.5 percentage of eyes |
| Week 1 | Bulbar Hyperemia - Enfilcon A Lens (Control) | Mild | 0.0 percentage of eyes |
| Week 1 | Bulbar Hyperemia - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Week 2 | Bulbar Hyperemia - Enfilcon A Lens (Control) | Trace | 27.6 percentage of eyes |
| Week 2 | Bulbar Hyperemia - Enfilcon A Lens (Control) | None | 72.4 percentage of eyes |
| Week 2 | Bulbar Hyperemia - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Week 2 | Bulbar Hyperemia - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
| Week 2 | Bulbar Hyperemia - Enfilcon A Lens (Control) | Mild | 0.0 percentage of eyes |
| Month 1 | Bulbar Hyperemia - Enfilcon A Lens (Control) | None | 69.0 percentage of eyes |
| Month 1 | Bulbar Hyperemia - Enfilcon A Lens (Control) | Trace | 31.0 percentage of eyes |
| Month 1 | Bulbar Hyperemia - Enfilcon A Lens (Control) | Mild | 0.0 percentage of eyes |
| Month 1 | Bulbar Hyperemia - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
| Month 1 | Bulbar Hyperemia - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Month 2 | Bulbar Hyperemia - Enfilcon A Lens (Control) | Trace | 7.1 percentage of eyes |
| Month 2 | Bulbar Hyperemia - Enfilcon A Lens (Control) | None | 92.9 percentage of eyes |
| Month 2 | Bulbar Hyperemia - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
| Month 2 | Bulbar Hyperemia - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Month 2 | Bulbar Hyperemia - Enfilcon A Lens (Control) | Mild | 0.0 percentage of eyes |
| Month 3 | Bulbar Hyperemia - Enfilcon A Lens (Control) | None | 81.0 percentage of eyes |
| Month 3 | Bulbar Hyperemia - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Month 3 | Bulbar Hyperemia - Enfilcon A Lens (Control) | Mild | 1.7 percentage of eyes |
| Month 3 | Bulbar Hyperemia - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
| Month 3 | Bulbar Hyperemia - Enfilcon A Lens (Control) | Trace | 17.2 percentage of eyes |
| Unscheduled | Bulbar Hyperemia - Enfilcon A Lens (Control) | Mild | 0.0 percentage of eyes |
| Unscheduled | Bulbar Hyperemia - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
| Unscheduled | Bulbar Hyperemia - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Unscheduled | Bulbar Hyperemia - Enfilcon A Lens (Control) | Trace | 0.0 percentage of eyes |
| Unscheduled | Bulbar Hyperemia - Enfilcon A Lens (Control) | None | 100.0 percentage of eyes |
Bulbar Hyperemia - Fanfilcon A Lens (Test)
Bulbar hyperemia is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Population: All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Baseline | Bulbar Hyperemia - Fanfilcon A Lens (Test) | Mild | 0.0 percentage of eyes |
| Baseline | Bulbar Hyperemia - Fanfilcon A Lens (Test) | None | 60.2 percentage of eyes |
| Baseline | Bulbar Hyperemia - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
| Baseline | Bulbar Hyperemia - Fanfilcon A Lens (Test) | Trace | 39.8 percentage of eyes |
| Baseline | Bulbar Hyperemia - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Week 1 | Bulbar Hyperemia - Fanfilcon A Lens (Test) | Mild | 0.9 percentage of eyes |
| Week 1 | Bulbar Hyperemia - Fanfilcon A Lens (Test) | Trace | 21.3 percentage of eyes |
| Week 1 | Bulbar Hyperemia - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Week 1 | Bulbar Hyperemia - Fanfilcon A Lens (Test) | None | 77.8 percentage of eyes |
| Week 1 | Bulbar Hyperemia - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
| Week 2 | Bulbar Hyperemia - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
| Week 2 | Bulbar Hyperemia - Fanfilcon A Lens (Test) | Trace | 32.1 percentage of eyes |
| Week 2 | Bulbar Hyperemia - Fanfilcon A Lens (Test) | None | 67.0 percentage of eyes |
| Week 2 | Bulbar Hyperemia - Fanfilcon A Lens (Test) | Mild | 0.9 percentage of eyes |
| Week 2 | Bulbar Hyperemia - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Month 1 | Bulbar Hyperemia - Fanfilcon A Lens (Test) | Mild | 0.0 percentage of eyes |
| Month 1 | Bulbar Hyperemia - Fanfilcon A Lens (Test) | None | 68.5 percentage of eyes |
| Month 1 | Bulbar Hyperemia - Fanfilcon A Lens (Test) | Trace | 31.5 percentage of eyes |
| Month 1 | Bulbar Hyperemia - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Month 1 | Bulbar Hyperemia - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
| Month 2 | Bulbar Hyperemia - Fanfilcon A Lens (Test) | None | 73.1 percentage of eyes |
| Month 2 | Bulbar Hyperemia - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
| Month 2 | Bulbar Hyperemia - Fanfilcon A Lens (Test) | Mild | 0.0 percentage of eyes |
| Month 2 | Bulbar Hyperemia - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Month 2 | Bulbar Hyperemia - Fanfilcon A Lens (Test) | Trace | 26.9 percentage of eyes |
| Month 3 | Bulbar Hyperemia - Fanfilcon A Lens (Test) | None | 69.4 percentage of eyes |
| Month 3 | Bulbar Hyperemia - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
| Month 3 | Bulbar Hyperemia - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Month 3 | Bulbar Hyperemia - Fanfilcon A Lens (Test) | Trace | 29.6 percentage of eyes |
| Month 3 | Bulbar Hyperemia - Fanfilcon A Lens (Test) | Mild | 0.9 percentage of eyes |
| Unscheduled | Bulbar Hyperemia - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Unscheduled | Bulbar Hyperemia - Fanfilcon A Lens (Test) | Trace | 33.3 percentage of eyes |
| Unscheduled | Bulbar Hyperemia - Fanfilcon A Lens (Test) | Mild | 0.0 percentage of eyes |
| Unscheduled | Bulbar Hyperemia - Fanfilcon A Lens (Test) | None | 66.7 percentage of eyes |
| Unscheduled | Bulbar Hyperemia - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
Corneal Infiltrates - Enfilcon A Lens (Control)
Corneal infiltrates is assessed for enfilcon A lens (control). Grading scale: absent/present
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Population: All sites, control completed subjects' eyes Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Baseline | Corneal Infiltrates - Enfilcon A Lens (Control) | Absent | 100.0 percentage of eyes |
| Baseline | Corneal Infiltrates - Enfilcon A Lens (Control) | Present | 0.0 percentage of eyes |
| Week 1 | Corneal Infiltrates - Enfilcon A Lens (Control) | Absent | 100.0 percentage of eyes |
| Week 1 | Corneal Infiltrates - Enfilcon A Lens (Control) | Present | 0.0 percentage of eyes |
| Week 2 | Corneal Infiltrates - Enfilcon A Lens (Control) | Absent | 100.0 percentage of eyes |
| Week 2 | Corneal Infiltrates - Enfilcon A Lens (Control) | Present | 0.0 percentage of eyes |
| Month 1 | Corneal Infiltrates - Enfilcon A Lens (Control) | Absent | 100.0 percentage of eyes |
| Month 1 | Corneal Infiltrates - Enfilcon A Lens (Control) | Present | 0.0 percentage of eyes |
| Month 2 | Corneal Infiltrates - Enfilcon A Lens (Control) | Absent | 100.0 percentage of eyes |
| Month 2 | Corneal Infiltrates - Enfilcon A Lens (Control) | Present | 0.0 percentage of eyes |
| Month 3 | Corneal Infiltrates - Enfilcon A Lens (Control) | Absent | 100.0 percentage of eyes |
| Month 3 | Corneal Infiltrates - Enfilcon A Lens (Control) | Present | 0.0 percentage of eyes |
| Unscheduled | Corneal Infiltrates - Enfilcon A Lens (Control) | Absent | 100.0 percentage of eyes |
| Unscheduled | Corneal Infiltrates - Enfilcon A Lens (Control) | Present | 0.0 percentage of eyes |
Corneal Infiltrates - Fanfilcon A Lens (Test)
Corneal infiltrates is assessed for fanfilcon A lens (test). Grading scale: Absent/present
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Population: All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Baseline | Corneal Infiltrates - Fanfilcon A Lens (Test) | Absent | 100.0 percentage of eyes |
| Baseline | Corneal Infiltrates - Fanfilcon A Lens (Test) | Present | 0.0 percentage of eyes |
| Week 1 | Corneal Infiltrates - Fanfilcon A Lens (Test) | Absent | 100.0 percentage of eyes |
| Week 1 | Corneal Infiltrates - Fanfilcon A Lens (Test) | Present | 0.0 percentage of eyes |
| Week 2 | Corneal Infiltrates - Fanfilcon A Lens (Test) | Absent | 100.0 percentage of eyes |
| Week 2 | Corneal Infiltrates - Fanfilcon A Lens (Test) | Present | 0.0 percentage of eyes |
| Month 1 | Corneal Infiltrates - Fanfilcon A Lens (Test) | Absent | 100.0 percentage of eyes |
| Month 1 | Corneal Infiltrates - Fanfilcon A Lens (Test) | Present | 0.0 percentage of eyes |
| Month 2 | Corneal Infiltrates - Fanfilcon A Lens (Test) | Absent | 100.0 percentage of eyes |
| Month 2 | Corneal Infiltrates - Fanfilcon A Lens (Test) | Present | 0.0 percentage of eyes |
| Month 3 | Corneal Infiltrates - Fanfilcon A Lens (Test) | Absent | 100.0 percentage of eyes |
| Month 3 | Corneal Infiltrates - Fanfilcon A Lens (Test) | Present | 0.0 percentage of eyes |
| Unscheduled | Corneal Infiltrates - Fanfilcon A Lens (Test) | Absent | 100.0 percentage of eyes |
| Unscheduled | Corneal Infiltrates - Fanfilcon A Lens (Test) | Present | 0.0 percentage of eyes |
Corneal Staining - Enfilcon A Lens (Control)
Corneal staining with fluorescein is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe; Grading regions: S - Superior, T - Temporal, C - Central, N - Nasal, I - Inferior;
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Population: All sites, control completed subjects' eyes. Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Baseline | Corneal Staining - Enfilcon A Lens (Control) | Temporal - Moderate | 0.0 percentage of eyes |
| Baseline | Corneal Staining - Enfilcon A Lens (Control) | Inferior - Mild | 0.0 percentage of eyes |
| Baseline | Corneal Staining - Enfilcon A Lens (Control) | Inferior - Trace | 48.3 percentage of eyes |
| Baseline | Corneal Staining - Enfilcon A Lens (Control) | Superior - Severe | 0.0 percentage of eyes |
| Baseline | Corneal Staining - Enfilcon A Lens (Control) | Superior - Moderate | 0.0 percentage of eyes |
| Baseline | Corneal Staining - Enfilcon A Lens (Control) | Central - Mild | 0.0 percentage of eyes |
| Baseline | Corneal Staining - Enfilcon A Lens (Control) | Superior - None | 75.9 percentage of eyes |
| Baseline | Corneal Staining - Enfilcon A Lens (Control) | Nasal - Mild | 0.0 percentage of eyes |
| Baseline | Corneal Staining - Enfilcon A Lens (Control) | Nasal - Trace | 37.9 percentage of eyes |
| Baseline | Corneal Staining - Enfilcon A Lens (Control) | Inferior - None | 51.7 percentage of eyes |
| Baseline | Corneal Staining - Enfilcon A Lens (Control) | Temporal - None | 65.5 percentage of eyes |
| Baseline | Corneal Staining - Enfilcon A Lens (Control) | Central - None | 62.1 percentage of eyes |
| Baseline | Corneal Staining - Enfilcon A Lens (Control) | Temporal - Severe | 0.0 percentage of eyes |
| Baseline | Corneal Staining - Enfilcon A Lens (Control) | Inferior - Superior | 0.0 percentage of eyes |
| Baseline | Corneal Staining - Enfilcon A Lens (Control) | Inferior - Moderate | 0.0 percentage of eyes |
| Baseline | Corneal Staining - Enfilcon A Lens (Control) | Central - Severe | 0.0 percentage of eyes |
| Baseline | Corneal Staining - Enfilcon A Lens (Control) | Nasal - Severe | 0.0 percentage of eyes |
| Baseline | Corneal Staining - Enfilcon A Lens (Control) | Temporal - Trace | 34.5 percentage of eyes |
| Baseline | Corneal Staining - Enfilcon A Lens (Control) | Central - Trace | 37.9 percentage of eyes |
| Baseline | Corneal Staining - Enfilcon A Lens (Control) | Central - Moderate | 0.0 percentage of eyes |
| Baseline | Corneal Staining - Enfilcon A Lens (Control) | Superior - Trace | 24.1 percentage of eyes |
| Baseline | Corneal Staining - Enfilcon A Lens (Control) | Superior - Mild | 0.0 percentage of eyes |
| Baseline | Corneal Staining - Enfilcon A Lens (Control) | Nasal - None | 62.1 percentage of eyes |
| Baseline | Corneal Staining - Enfilcon A Lens (Control) | Nasal - Moderate | 0.0 percentage of eyes |
| Baseline | Corneal Staining - Enfilcon A Lens (Control) | Temporal - Mild | 0.0 percentage of eyes |
| Week 1 | Corneal Staining - Enfilcon A Lens (Control) | Temporal - Trace | 15.4 percentage of eyes |
| Week 1 | Corneal Staining - Enfilcon A Lens (Control) | Superior - Mild | 0.0 percentage of eyes |
| Week 1 | Corneal Staining - Enfilcon A Lens (Control) | Superior - Trace | 15.4 percentage of eyes |
| Week 1 | Corneal Staining - Enfilcon A Lens (Control) | Central - Severe | 0.0 percentage of eyes |
| Week 1 | Corneal Staining - Enfilcon A Lens (Control) | Nasal - Mild | 3.8 percentage of eyes |
| Week 1 | Corneal Staining - Enfilcon A Lens (Control) | Temporal - Moderate | 0.0 percentage of eyes |
| Week 1 | Corneal Staining - Enfilcon A Lens (Control) | Superior - None | 84.6 percentage of eyes |
| Week 1 | Corneal Staining - Enfilcon A Lens (Control) | Inferior - Moderate | 0.0 percentage of eyes |
| Week 1 | Corneal Staining - Enfilcon A Lens (Control) | Inferior - Mild | 7.7 percentage of eyes |
| Week 1 | Corneal Staining - Enfilcon A Lens (Control) | Nasal - Trace | 26.9 percentage of eyes |
| Week 1 | Corneal Staining - Enfilcon A Lens (Control) | Temporal - Severe | 0.0 percentage of eyes |
| Week 1 | Corneal Staining - Enfilcon A Lens (Control) | Superior - Moderate | 0.0 percentage of eyes |
| Week 1 | Corneal Staining - Enfilcon A Lens (Control) | Nasal - None | 73.0 percentage of eyes |
| Week 1 | Corneal Staining - Enfilcon A Lens (Control) | Central - None | 73.1 percentage of eyes |
| Week 1 | Corneal Staining - Enfilcon A Lens (Control) | Central - Moderate | 0.0 percentage of eyes |
| Week 1 | Corneal Staining - Enfilcon A Lens (Control) | Inferior - Trace | 42.3 percentage of eyes |
| Week 1 | Corneal Staining - Enfilcon A Lens (Control) | Superior - Severe | 0.0 percentage of eyes |
| Week 1 | Corneal Staining - Enfilcon A Lens (Control) | Inferior - Superior | 0.0 percentage of eyes |
| Week 1 | Corneal Staining - Enfilcon A Lens (Control) | Central - Mild | 0.0 percentage of eyes |
| Week 1 | Corneal Staining - Enfilcon A Lens (Control) | Inferior - None | 57.6 percentage of eyes |
| Week 1 | Corneal Staining - Enfilcon A Lens (Control) | Temporal - None | 84.6 percentage of eyes |
| Week 1 | Corneal Staining - Enfilcon A Lens (Control) | Central - Trace | 26.9 percentage of eyes |
| Week 1 | Corneal Staining - Enfilcon A Lens (Control) | Nasal - Severe | 0.0 percentage of eyes |
| Week 1 | Corneal Staining - Enfilcon A Lens (Control) | Temporal - Mild | 0.0 percentage of eyes |
| Week 1 | Corneal Staining - Enfilcon A Lens (Control) | Nasal - Moderate | 0.0 percentage of eyes |
| Week 2 | Corneal Staining - Enfilcon A Lens (Control) | Nasal - Moderate | 0.0 percentage of eyes |
| Week 2 | Corneal Staining - Enfilcon A Lens (Control) | Central - Trace | 20.7 percentage of eyes |
| Week 2 | Corneal Staining - Enfilcon A Lens (Control) | Central - Moderate | 0.0 percentage of eyes |
| Week 2 | Corneal Staining - Enfilcon A Lens (Control) | Central - Mild | 0.0 percentage of eyes |
| Week 2 | Corneal Staining - Enfilcon A Lens (Control) | Superior - Mild | 0.0 percentage of eyes |
| Week 2 | Corneal Staining - Enfilcon A Lens (Control) | Inferior - Mild | 3.4 percentage of eyes |
| Week 2 | Corneal Staining - Enfilcon A Lens (Control) | Superior - Moderate | 0.0 percentage of eyes |
| Week 2 | Corneal Staining - Enfilcon A Lens (Control) | Inferior - Superior | 0.0 percentage of eyes |
| Week 2 | Corneal Staining - Enfilcon A Lens (Control) | Inferior - Trace | 72.4 percentage of eyes |
| Week 2 | Corneal Staining - Enfilcon A Lens (Control) | Superior - Severe | 0.0 percentage of eyes |
| Week 2 | Corneal Staining - Enfilcon A Lens (Control) | Inferior - None | 27.6 percentage of eyes |
| Week 2 | Corneal Staining - Enfilcon A Lens (Control) | Temporal - None | 75.9 percentage of eyes |
| Week 2 | Corneal Staining - Enfilcon A Lens (Control) | Nasal - Severe | 0.0 percentage of eyes |
| Week 2 | Corneal Staining - Enfilcon A Lens (Control) | Temporal - Trace | 24.1 percentage of eyes |
| Week 2 | Corneal Staining - Enfilcon A Lens (Control) | Central - Severe | 0.0 percentage of eyes |
| Week 2 | Corneal Staining - Enfilcon A Lens (Control) | Temporal - Mild | 0.0 percentage of eyes |
| Week 2 | Corneal Staining - Enfilcon A Lens (Control) | Nasal - Mild | 0.0 percentage of eyes |
| Week 2 | Corneal Staining - Enfilcon A Lens (Control) | Temporal - Moderate | 0.0 percentage of eyes |
| Week 2 | Corneal Staining - Enfilcon A Lens (Control) | Superior - Trace | 3.4 percentage of eyes |
| Week 2 | Corneal Staining - Enfilcon A Lens (Control) | Nasal - Trace | 34.5 percentage of eyes |
| Week 2 | Corneal Staining - Enfilcon A Lens (Control) | Temporal - Severe | 0.0 percentage of eyes |
| Week 2 | Corneal Staining - Enfilcon A Lens (Control) | Superior - None | 96.6 percentage of eyes |
| Week 2 | Corneal Staining - Enfilcon A Lens (Control) | Nasal - None | 65.5 percentage of eyes |
| Week 2 | Corneal Staining - Enfilcon A Lens (Control) | Central - None | 79.3 percentage of eyes |
| Week 2 | Corneal Staining - Enfilcon A Lens (Control) | Inferior - Moderate | 0.0 percentage of eyes |
| Month 1 | Corneal Staining - Enfilcon A Lens (Control) | Nasal - None | 79.3 percentage of eyes |
| Month 1 | Corneal Staining - Enfilcon A Lens (Control) | Superior - None | 93.1 percentage of eyes |
| Month 1 | Corneal Staining - Enfilcon A Lens (Control) | Superior - Trace | 6.9 percentage of eyes |
| Month 1 | Corneal Staining - Enfilcon A Lens (Control) | Superior - Mild | 0.0 percentage of eyes |
| Month 1 | Corneal Staining - Enfilcon A Lens (Control) | Superior - Moderate | 0.0 percentage of eyes |
| Month 1 | Corneal Staining - Enfilcon A Lens (Control) | Superior - Severe | 0.0 percentage of eyes |
| Month 1 | Corneal Staining - Enfilcon A Lens (Control) | Temporal - None | 89.7 percentage of eyes |
| Month 1 | Corneal Staining - Enfilcon A Lens (Control) | Temporal - Trace | 10.3 percentage of eyes |
| Month 1 | Corneal Staining - Enfilcon A Lens (Control) | Temporal - Mild | 0.0 percentage of eyes |
| Month 1 | Corneal Staining - Enfilcon A Lens (Control) | Temporal - Moderate | 0.0 percentage of eyes |
| Month 1 | Corneal Staining - Enfilcon A Lens (Control) | Temporal - Severe | 0.0 percentage of eyes |
| Month 1 | Corneal Staining - Enfilcon A Lens (Control) | Central - None | 75.8 percentage of eyes |
| Month 1 | Corneal Staining - Enfilcon A Lens (Control) | Central - Trace | 24.1 percentage of eyes |
| Month 1 | Corneal Staining - Enfilcon A Lens (Control) | Central - Mild | 3.4 percentage of eyes |
| Month 1 | Corneal Staining - Enfilcon A Lens (Control) | Central - Moderate | 0.0 percentage of eyes |
| Month 1 | Corneal Staining - Enfilcon A Lens (Control) | Central - Severe | 0.0 percentage of eyes |
| Month 1 | Corneal Staining - Enfilcon A Lens (Control) | Nasal - Trace | 20.7 percentage of eyes |
| Month 1 | Corneal Staining - Enfilcon A Lens (Control) | Nasal - Mild | 0.0 percentage of eyes |
| Month 1 | Corneal Staining - Enfilcon A Lens (Control) | Nasal - Moderate | 0.0 percentage of eyes |
| Month 1 | Corneal Staining - Enfilcon A Lens (Control) | Nasal - Severe | 0.0 percentage of eyes |
| Month 1 | Corneal Staining - Enfilcon A Lens (Control) | Inferior - None | 62.0 percentage of eyes |
| Month 1 | Corneal Staining - Enfilcon A Lens (Control) | Inferior - Trace | 37.9 percentage of eyes |
| Month 1 | Corneal Staining - Enfilcon A Lens (Control) | Inferior - Mild | 10.3 percentage of eyes |
| Month 1 | Corneal Staining - Enfilcon A Lens (Control) | Inferior - Moderate | 0.0 percentage of eyes |
| Month 1 | Corneal Staining - Enfilcon A Lens (Control) | Inferior - Superior | 0.0 percentage of eyes |
| Month 2 | Corneal Staining - Enfilcon A Lens (Control) | Inferior - Trace | 46.4 percentage of eyes |
| Month 2 | Corneal Staining - Enfilcon A Lens (Control) | Superior - Moderate | 0.0 percentage of eyes |
| Month 2 | Corneal Staining - Enfilcon A Lens (Control) | Nasal - None | 78.6 percentage of eyes |
| Month 2 | Corneal Staining - Enfilcon A Lens (Control) | Temporal - Trace | 25.0 percentage of eyes |
| Month 2 | Corneal Staining - Enfilcon A Lens (Control) | Inferior - None | 53.5 percentage of eyes |
| Month 2 | Corneal Staining - Enfilcon A Lens (Control) | Nasal - Moderate | 0.0 percentage of eyes |
| Month 2 | Corneal Staining - Enfilcon A Lens (Control) | Inferior - Moderate | 0.0 percentage of eyes |
| Month 2 | Corneal Staining - Enfilcon A Lens (Control) | Superior - None | 78.6 percentage of eyes |
| Month 2 | Corneal Staining - Enfilcon A Lens (Control) | Superior - Severe | 0.0 percentage of eyes |
| Month 2 | Corneal Staining - Enfilcon A Lens (Control) | Central - Mild | 0.0 percentage of eyes |
| Month 2 | Corneal Staining - Enfilcon A Lens (Control) | Temporal - None | 75.0 percentage of eyes |
| Month 2 | Corneal Staining - Enfilcon A Lens (Control) | Superior - Trace | 21.4 percentage of eyes |
| Month 2 | Corneal Staining - Enfilcon A Lens (Control) | Nasal - Severe | 0.0 percentage of eyes |
| Month 2 | Corneal Staining - Enfilcon A Lens (Control) | Central - Trace | 14.3 percentage of eyes |
| Month 2 | Corneal Staining - Enfilcon A Lens (Control) | Temporal - Moderate | 0.0 percentage of eyes |
| Month 2 | Corneal Staining - Enfilcon A Lens (Control) | Central - None | 85.7 percentage of eyes |
| Month 2 | Corneal Staining - Enfilcon A Lens (Control) | Nasal - Trace | 21.4 percentage of eyes |
| Month 2 | Corneal Staining - Enfilcon A Lens (Control) | Central - Moderate | 0.0 percentage of eyes |
| Month 2 | Corneal Staining - Enfilcon A Lens (Control) | Inferior - Mild | 3.6 percentage of eyes |
| Month 2 | Corneal Staining - Enfilcon A Lens (Control) | Inferior - Superior | 0.0 percentage of eyes |
| Month 2 | Corneal Staining - Enfilcon A Lens (Control) | Central - Severe | 0.0 percentage of eyes |
| Month 2 | Corneal Staining - Enfilcon A Lens (Control) | Temporal - Mild | 0.0 percentage of eyes |
| Month 2 | Corneal Staining - Enfilcon A Lens (Control) | Superior - Mild | 0.0 percentage of eyes |
| Month 2 | Corneal Staining - Enfilcon A Lens (Control) | Nasal - Mild | 0.0 percentage of eyes |
| Month 2 | Corneal Staining - Enfilcon A Lens (Control) | Temporal - Severe | 0.0 percentage of eyes |
| Month 3 | Corneal Staining - Enfilcon A Lens (Control) | Central - None | 82.8 percentage of eyes |
| Month 3 | Corneal Staining - Enfilcon A Lens (Control) | Central - Severe | 0.0 percentage of eyes |
| Month 3 | Corneal Staining - Enfilcon A Lens (Control) | Temporal - Severe | 0.0 percentage of eyes |
| Month 3 | Corneal Staining - Enfilcon A Lens (Control) | Nasal - None | 75.9 percentage of eyes |
| Month 3 | Corneal Staining - Enfilcon A Lens (Control) | Temporal - Moderate | 0.0 percentage of eyes |
| Month 3 | Corneal Staining - Enfilcon A Lens (Control) | Inferior - Moderate | 0.0 percentage of eyes |
| Month 3 | Corneal Staining - Enfilcon A Lens (Control) | Nasal - Trace | 24.1 percentage of eyes |
| Month 3 | Corneal Staining - Enfilcon A Lens (Control) | Temporal - Mild | 6.9 percentage of eyes |
| Month 3 | Corneal Staining - Enfilcon A Lens (Control) | Nasal - Mild | 1.8 percentage of eyes |
| Month 3 | Corneal Staining - Enfilcon A Lens (Control) | Temporal - Trace | 10.3 percentage of eyes |
| Month 3 | Corneal Staining - Enfilcon A Lens (Control) | Nasal - Moderate | 0.0 percentage of eyes |
| Month 3 | Corneal Staining - Enfilcon A Lens (Control) | Temporal - None | 89.6 percentage of eyes |
| Month 3 | Corneal Staining - Enfilcon A Lens (Control) | Superior - None | 93.1 percentage of eyes |
| Month 3 | Corneal Staining - Enfilcon A Lens (Control) | Nasal - Severe | 0.0 percentage of eyes |
| Month 3 | Corneal Staining - Enfilcon A Lens (Control) | Superior - Severe | 0.0 percentage of eyes |
| Month 3 | Corneal Staining - Enfilcon A Lens (Control) | Inferior - None | 44.8 percentage of eyes |
| Month 3 | Corneal Staining - Enfilcon A Lens (Control) | Superior - Moderate | 0.0 percentage of eyes |
| Month 3 | Corneal Staining - Enfilcon A Lens (Control) | Inferior - Trace | 55.2 percentage of eyes |
| Month 3 | Corneal Staining - Enfilcon A Lens (Control) | Superior - Mild | 0.0 percentage of eyes |
| Month 3 | Corneal Staining - Enfilcon A Lens (Control) | Inferior - Mild | 3.4 percentage of eyes |
| Month 3 | Corneal Staining - Enfilcon A Lens (Control) | Superior - Trace | 6.9 percentage of eyes |
| Month 3 | Corneal Staining - Enfilcon A Lens (Control) | Central - Mild | 0.0 percentage of eyes |
| Month 3 | Corneal Staining - Enfilcon A Lens (Control) | Central - Trace | 17.2 percentage of eyes |
| Month 3 | Corneal Staining - Enfilcon A Lens (Control) | Inferior - Superior | 0.0 percentage of eyes |
| Month 3 | Corneal Staining - Enfilcon A Lens (Control) | Central - Moderate | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Enfilcon A Lens (Control) | Inferior - Superior | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Enfilcon A Lens (Control) | Nasal - Mild | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Enfilcon A Lens (Control) | Central - Trace | 8.3 percentage of eyes |
| Unscheduled | Corneal Staining - Enfilcon A Lens (Control) | Inferior - Trace | 33.3 percentage of eyes |
| Unscheduled | Corneal Staining - Enfilcon A Lens (Control) | Superior - Mild | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Enfilcon A Lens (Control) | Central - Moderate | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Enfilcon A Lens (Control) | Inferior - Moderate | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Enfilcon A Lens (Control) | Temporal - Mild | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Enfilcon A Lens (Control) | Nasal - Trace | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Enfilcon A Lens (Control) | Central - Severe | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Enfilcon A Lens (Control) | Inferior - Mild | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Enfilcon A Lens (Control) | Superior - Trace | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Enfilcon A Lens (Control) | Temporal - Severe | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Enfilcon A Lens (Control) | Temporal - Moderate | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Enfilcon A Lens (Control) | Nasal - Severe | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Enfilcon A Lens (Control) | Superior - Severe | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Enfilcon A Lens (Control) | Central - None | 83.4 percentage of eyes |
| Unscheduled | Corneal Staining - Enfilcon A Lens (Control) | Temporal - None | 100.0 percentage of eyes |
| Unscheduled | Corneal Staining - Enfilcon A Lens (Control) | Nasal - Moderate | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Enfilcon A Lens (Control) | Superior - None | 100.0 percentage of eyes |
| Unscheduled | Corneal Staining - Enfilcon A Lens (Control) | Central - Mild | 8.3 percentage of eyes |
| Unscheduled | Corneal Staining - Enfilcon A Lens (Control) | Inferior - None | 66.7 percentage of eyes |
| Unscheduled | Corneal Staining - Enfilcon A Lens (Control) | Superior - Moderate | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Enfilcon A Lens (Control) | Nasal - None | 100.0 percentage of eyes |
| Unscheduled | Corneal Staining - Enfilcon A Lens (Control) | Temporal - Trace | 0.0 percentage of eyes |
Corneal Staining - Fanfilcon A Lens (Test)
Corneal staining with fluorescein is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe; Grading regions: S - Superior, T - Temporal, C - Central, N - Nasal, I - Inferior;
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Population: All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Baseline | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - Moderate | 0.0 percentage of eyes |
| Baseline | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - Mild | 0.0 percentage of eyes |
| Baseline | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - Trace | 29.6 percentage of eyes |
| Baseline | Corneal Staining - Fanfilcon A Lens (Test) | Superior - Severe | 0.0 percentage of eyes |
| Baseline | Corneal Staining - Fanfilcon A Lens (Test) | Superior - Moderate | 0.0 percentage of eyes |
| Baseline | Corneal Staining - Fanfilcon A Lens (Test) | Central - Mild | 0.0 percentage of eyes |
| Baseline | Corneal Staining - Fanfilcon A Lens (Test) | Superior - None | 96.3 percentage of eyes |
| Baseline | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - Mild | 0.0 percentage of eyes |
| Baseline | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - Trace | 9.3 percentage of eyes |
| Baseline | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - None | 70.4 percentage of eyes |
| Baseline | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - None | 93.5 percentage of eyes |
| Baseline | Corneal Staining - Fanfilcon A Lens (Test) | Central - None | 94.4 percentage of eyes |
| Baseline | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - Severe | 0.0 percentage of eyes |
| Baseline | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - Severe | 0.0 percentage of eyes |
| Baseline | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - Moderate | 0.0 percentage of eyes |
| Baseline | Corneal Staining - Fanfilcon A Lens (Test) | Central - Severe | 0.0 percentage of eyes |
| Baseline | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - Severe | 0.0 percentage of eyes |
| Baseline | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - Trace | 6.5 percentage of eyes |
| Baseline | Corneal Staining - Fanfilcon A Lens (Test) | Central - Trace | 5.6 percentage of eyes |
| Baseline | Corneal Staining - Fanfilcon A Lens (Test) | Central - Moderate | 0.0 percentage of eyes |
| Baseline | Corneal Staining - Fanfilcon A Lens (Test) | Superior - Trace | 3.7 percentage of eyes |
| Baseline | Corneal Staining - Fanfilcon A Lens (Test) | Superior - Mild | 0.0 percentage of eyes |
| Baseline | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - None | 90.7 percentage of eyes |
| Baseline | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - Moderate | 0.0 percentage of eyes |
| Baseline | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - Mild | 0.0 percentage of eyes |
| Week 1 | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - Trace | 2.8 percentage of eyes |
| Week 1 | Corneal Staining - Fanfilcon A Lens (Test) | Superior - Mild | 0.0 percentage of eyes |
| Week 1 | Corneal Staining - Fanfilcon A Lens (Test) | Superior - Trace | 7.4 percentage of eyes |
| Week 1 | Corneal Staining - Fanfilcon A Lens (Test) | Central - Severe | 0.0 percentage of eyes |
| Week 1 | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - Mild | 1.9 percentage of eyes |
| Week 1 | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - Moderate | 0.0 percentage of eyes |
| Week 1 | Corneal Staining - Fanfilcon A Lens (Test) | Superior - None | 92.6 percentage of eyes |
| Week 1 | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - Moderate | 0.0 percentage of eyes |
| Week 1 | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - Mild | 0.9 percentage of eyes |
| Week 1 | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - Trace | 7.4 percentage of eyes |
| Week 1 | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - Severe | 0.0 percentage of eyes |
| Week 1 | Corneal Staining - Fanfilcon A Lens (Test) | Superior - Moderate | 0.0 percentage of eyes |
| Week 1 | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - None | 90.7 percentage of eyes |
| Week 1 | Corneal Staining - Fanfilcon A Lens (Test) | Central - None | 88.9 percentage of eyes |
| Week 1 | Corneal Staining - Fanfilcon A Lens (Test) | Central - Moderate | 0.0 percentage of eyes |
| Week 1 | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - Trace | 28.7 percentage of eyes |
| Week 1 | Corneal Staining - Fanfilcon A Lens (Test) | Superior - Severe | 0.0 percentage of eyes |
| Week 1 | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - Severe | 0.0 percentage of eyes |
| Week 1 | Corneal Staining - Fanfilcon A Lens (Test) | Central - Mild | 0.0 percentage of eyes |
| Week 1 | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - None | 70.4 percentage of eyes |
| Week 1 | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - None | 97.2 percentage of eyes |
| Week 1 | Corneal Staining - Fanfilcon A Lens (Test) | Central - Trace | 11.1 percentage of eyes |
| Week 1 | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - Severe | 0.0 percentage of eyes |
| Week 1 | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - Mild | 0.0 percentage of eyes |
| Week 1 | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - Moderate | 0.0 percentage of eyes |
| Week 2 | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - Moderate | 0.0 percentage of eyes |
| Week 2 | Corneal Staining - Fanfilcon A Lens (Test) | Central - Trace | 10.4 percentage of eyes |
| Week 2 | Corneal Staining - Fanfilcon A Lens (Test) | Central - Moderate | 0.0 percentage of eyes |
| Week 2 | Corneal Staining - Fanfilcon A Lens (Test) | Central - Mild | 0.9 percentage of eyes |
| Week 2 | Corneal Staining - Fanfilcon A Lens (Test) | Superior - Mild | 3.8 percentage of eyes |
| Week 2 | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - Mild | 6.6 percentage of eyes |
| Week 2 | Corneal Staining - Fanfilcon A Lens (Test) | Superior - Moderate | 0.0 percentage of eyes |
| Week 2 | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - Severe | 0.0 percentage of eyes |
| Week 2 | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - Trace | 21.7 percentage of eyes |
| Week 2 | Corneal Staining - Fanfilcon A Lens (Test) | Superior - Severe | 0.0 percentage of eyes |
| Week 2 | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - None | 71.7 percentage of eyes |
| Week 2 | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - None | 95.3 percentage of eyes |
| Week 2 | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - Severe | 0.0 percentage of eyes |
| Week 2 | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - Trace | 3.8 percentage of eyes |
| Week 2 | Corneal Staining - Fanfilcon A Lens (Test) | Central - Severe | 0.0 percentage of eyes |
| Week 2 | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - Mild | 0.9 percentage of eyes |
| Week 2 | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - Mild | 0.0 percentage of eyes |
| Week 2 | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - Moderate | 0.0 percentage of eyes |
| Week 2 | Corneal Staining - Fanfilcon A Lens (Test) | Superior - Trace | 2.8 percentage of eyes |
| Week 2 | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - Trace | 3.8 percentage of eyes |
| Week 2 | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - Severe | 0.0 percentage of eyes |
| Week 2 | Corneal Staining - Fanfilcon A Lens (Test) | Superior - None | 93.4 percentage of eyes |
| Week 2 | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - None | 96.2 percentage of eyes |
| Week 2 | Corneal Staining - Fanfilcon A Lens (Test) | Central - None | 88.7 percentage of eyes |
| Week 2 | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - Moderate | 0.0 percentage of eyes |
| Month 1 | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - None | 92.6 percentage of eyes |
| Month 1 | Corneal Staining - Fanfilcon A Lens (Test) | Superior - None | 93.5 percentage of eyes |
| Month 1 | Corneal Staining - Fanfilcon A Lens (Test) | Superior - Trace | 6.5 percentage of eyes |
| Month 1 | Corneal Staining - Fanfilcon A Lens (Test) | Superior - Mild | 0 percentage of eyes |
| Month 1 | Corneal Staining - Fanfilcon A Lens (Test) | Superior - Moderate | 0.0 percentage of eyes |
| Month 1 | Corneal Staining - Fanfilcon A Lens (Test) | Superior - Severe | 0.0 percentage of eyes |
| Month 1 | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - None | 96.3 percentage of eyes |
| Month 1 | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - Trace | 2.8 percentage of eyes |
| Month 1 | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - Mild | 0.9 percentage of eyes |
| Month 1 | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - Moderate | 0.0 percentage of eyes |
| Month 1 | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - Severe | 0.0 percentage of eyes |
| Month 1 | Corneal Staining - Fanfilcon A Lens (Test) | Central - None | 88.0 percentage of eyes |
| Month 1 | Corneal Staining - Fanfilcon A Lens (Test) | Central - Trace | 11.1 percentage of eyes |
| Month 1 | Corneal Staining - Fanfilcon A Lens (Test) | Central - Mild | 0.9 percentage of eyes |
| Month 1 | Corneal Staining - Fanfilcon A Lens (Test) | Central - Moderate | 0.0 percentage of eyes |
| Month 1 | Corneal Staining - Fanfilcon A Lens (Test) | Central - Severe | 0.0 percentage of eyes |
| Month 1 | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - Trace | 5.6 percentage of eyes |
| Month 1 | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - Mild | 1.9 percentage of eyes |
| Month 1 | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - Moderate | 0.0 percentage of eyes |
| Month 1 | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - Severe | 0.0 percentage of eyes |
| Month 1 | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - None | 74.1 percentage of eyes |
| Month 1 | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - Trace | 17.6 percentage of eyes |
| Month 1 | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - Mild | 8.3 percentage of eyes |
| Month 1 | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - Moderate | 0.0 percentage of eyes |
| Month 1 | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - Severe | 0.0 percentage of eyes |
| Month 2 | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - Trace | 23.1 percentage of eyes |
| Month 2 | Corneal Staining - Fanfilcon A Lens (Test) | Superior - Moderate | 0.0 percentage of eyes |
| Month 2 | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - None | 95.4 percentage of eyes |
| Month 2 | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - Trace | 5.6 percentage of eyes |
| Month 2 | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - None | 67.6 percentage of eyes |
| Month 2 | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - Moderate | 0.0 percentage of eyes |
| Month 2 | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - Moderate | 0.0 percentage of eyes |
| Month 2 | Corneal Staining - Fanfilcon A Lens (Test) | Superior - None | 97.2 percentage of eyes |
| Month 2 | Corneal Staining - Fanfilcon A Lens (Test) | Superior - Severe | 0.0 percentage of eyes |
| Month 2 | Corneal Staining - Fanfilcon A Lens (Test) | Central - Mild | 1.9 percentage of eyes |
| Month 2 | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - None | 92.6 percentage of eyes |
| Month 2 | Corneal Staining - Fanfilcon A Lens (Test) | Superior - Trace | 2.8 percentage of eyes |
| Month 2 | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - Severe | 0.0 percentage of eyes |
| Month 2 | Corneal Staining - Fanfilcon A Lens (Test) | Central - Trace | 2.8 percentage of eyes |
| Month 2 | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - Moderate | 0.0 percentage of eyes |
| Month 2 | Corneal Staining - Fanfilcon A Lens (Test) | Central - None | 95.4 percentage of eyes |
| Month 2 | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - Trace | 3.7 percentage of eyes |
| Month 2 | Corneal Staining - Fanfilcon A Lens (Test) | Central - Moderate | 0.0 percentage of eyes |
| Month 2 | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - Mild | 9.3 percentage of eyes |
| Month 2 | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - Severe | 0.0 percentage of eyes |
| Month 2 | Corneal Staining - Fanfilcon A Lens (Test) | Central - Severe | 0.0 percentage of eyes |
| Month 2 | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - Mild | 1.9 percentage of eyes |
| Month 2 | Corneal Staining - Fanfilcon A Lens (Test) | Superior - Mild | 0 percentage of eyes |
| Month 2 | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - Mild | 0.9 percentage of eyes |
| Month 2 | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - Severe | 0.0 percentage of eyes |
| Month 3 | Corneal Staining - Fanfilcon A Lens (Test) | Central - None | 88.9 percentage of eyes |
| Month 3 | Corneal Staining - Fanfilcon A Lens (Test) | Central - Severe | 0.0 percentage of eyes |
| Month 3 | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - Severe | 0.0 percentage of eyes |
| Month 3 | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - None | 96.3 percentage of eyes |
| Month 3 | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - Moderate | 0.0 percentage of eyes |
| Month 3 | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - Moderate | 0.0 percentage of eyes |
| Month 3 | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - Trace | 3.7 percentage of eyes |
| Month 3 | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - Mild | 0.9 percentage of eyes |
| Month 3 | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - Mild | 0.0 percentage of eyes |
| Month 3 | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - Trace | 8.3 percentage of eyes |
| Month 3 | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - Moderate | 0.0 percentage of eyes |
| Month 3 | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - None | 90.7 percentage of eyes |
| Month 3 | Corneal Staining - Fanfilcon A Lens (Test) | Superior - None | 96.3 percentage of eyes |
| Month 3 | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - Severe | 0.0 percentage of eyes |
| Month 3 | Corneal Staining - Fanfilcon A Lens (Test) | Superior - Severe | 0.0 percentage of eyes |
| Month 3 | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - None | 70.4 percentage of eyes |
| Month 3 | Corneal Staining - Fanfilcon A Lens (Test) | Superior - Moderate | 0.0 percentage of eyes |
| Month 3 | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - Trace | 23.1 percentage of eyes |
| Month 3 | Corneal Staining - Fanfilcon A Lens (Test) | Superior - Mild | 0.9 percentage of eyes |
| Month 3 | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - Mild | 6.5 percentage of eyes |
| Month 3 | Corneal Staining - Fanfilcon A Lens (Test) | Superior - Trace | 2.8 percentage of eyes |
| Month 3 | Corneal Staining - Fanfilcon A Lens (Test) | Central - Mild | 0.0 percentage of eyes |
| Month 3 | Corneal Staining - Fanfilcon A Lens (Test) | Central - Trace | 11.1 percentage of eyes |
| Month 3 | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - Severe | 0.0 percentage of eyes |
| Month 3 | Corneal Staining - Fanfilcon A Lens (Test) | Central - Moderate | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - Severe | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - Mild | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Fanfilcon A Lens (Test) | Central - Trace | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - Trace | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Fanfilcon A Lens (Test) | Superior - Mild | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Fanfilcon A Lens (Test) | Central - Moderate | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - Moderate | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - Mild | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - Trace | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Fanfilcon A Lens (Test) | Central - Severe | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - Mild | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Fanfilcon A Lens (Test) | Superior - Trace | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - Severe | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - Moderate | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - Severe | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Fanfilcon A Lens (Test) | Superior - Severe | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Fanfilcon A Lens (Test) | Central - None | 100.0 percentage of eyes |
| Unscheduled | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - None | 100.0 percentage of eyes |
| Unscheduled | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - Moderate | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Fanfilcon A Lens (Test) | Superior - None | 100.0 percentage of eyes |
| Unscheduled | Corneal Staining - Fanfilcon A Lens (Test) | Central - Mild | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Fanfilcon A Lens (Test) | Inferior - None | 100.0 percentage of eyes |
| Unscheduled | Corneal Staining - Fanfilcon A Lens (Test) | Superior - Moderate | 0.0 percentage of eyes |
| Unscheduled | Corneal Staining - Fanfilcon A Lens (Test) | Nasal - None | 100.0 percentage of eyes |
| Unscheduled | Corneal Staining - Fanfilcon A Lens (Test) | Temporal - Trace | 0.0 percentage of eyes |
Corneal Vascularization - Enfilcon A Lens (Control)
Corneal vascularization is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Population: All sites, control completed subjects' eyes. Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Baseline | Corneal Vascularization - Enfilcon A Lens (Control) | Mild | 0.0 percentage of eyes |
| Baseline | Corneal Vascularization - Enfilcon A Lens (Control) | None | 86.2 percentage of eyes |
| Baseline | Corneal Vascularization - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
| Baseline | Corneal Vascularization - Enfilcon A Lens (Control) | Trace | 13.8 percentage of eyes |
| Baseline | Corneal Vascularization - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Week 1 | Corneal Vascularization - Enfilcon A Lens (Control) | Mild | 0.0 percentage of eyes |
| Week 1 | Corneal Vascularization - Enfilcon A Lens (Control) | Trace | 7.7 percentage of eyes |
| Week 1 | Corneal Vascularization - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Week 1 | Corneal Vascularization - Enfilcon A Lens (Control) | None | 92.3 percentage of eyes |
| Week 1 | Corneal Vascularization - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
| Week 2 | Corneal Vascularization - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
| Week 2 | Corneal Vascularization - Enfilcon A Lens (Control) | Trace | 6.9 percentage of eyes |
| Week 2 | Corneal Vascularization - Enfilcon A Lens (Control) | None | 93.1 percentage of eyes |
| Week 2 | Corneal Vascularization - Enfilcon A Lens (Control) | Mild | 0.0 percentage of eyes |
| Week 2 | Corneal Vascularization - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Month 1 | Corneal Vascularization - Enfilcon A Lens (Control) | Mild | 0.0 percentage of eyes |
| Month 1 | Corneal Vascularization - Enfilcon A Lens (Control) | None | 93.1 percentage of eyes |
| Month 1 | Corneal Vascularization - Enfilcon A Lens (Control) | Trace | 6.9 percentage of eyes |
| Month 1 | Corneal Vascularization - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Month 1 | Corneal Vascularization - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
| Month 2 | Corneal Vascularization - Enfilcon A Lens (Control) | None | 96.4 percentage of eyes |
| Month 2 | Corneal Vascularization - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
| Month 2 | Corneal Vascularization - Enfilcon A Lens (Control) | Mild | 0.0 percentage of eyes |
| Month 2 | Corneal Vascularization - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Month 2 | Corneal Vascularization - Enfilcon A Lens (Control) | Trace | 3.6 percentage of eyes |
| Month 3 | Corneal Vascularization - Enfilcon A Lens (Control) | None | 96.6 percentage of eyes |
| Month 3 | Corneal Vascularization - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
| Month 3 | Corneal Vascularization - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Month 3 | Corneal Vascularization - Enfilcon A Lens (Control) | Trace | 3.4 percentage of eyes |
| Month 3 | Corneal Vascularization - Enfilcon A Lens (Control) | Mild | 0.0 percentage of eyes |
| Unscheduled | Corneal Vascularization - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Unscheduled | Corneal Vascularization - Enfilcon A Lens (Control) | Trace | 0.0 percentage of eyes |
| Unscheduled | Corneal Vascularization - Enfilcon A Lens (Control) | Mild | 0.0 percentage of eyes |
| Unscheduled | Corneal Vascularization - Enfilcon A Lens (Control) | None | 100.0 percentage of eyes |
| Unscheduled | Corneal Vascularization - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
Corneal Vascularization - Fanfilcon A Lens (Test)
Corneal vascularization is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Population: All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Baseline | Corneal Vascularization - Fanfilcon A Lens (Test) | Mild | 0.0 percentage of eyes |
| Baseline | Corneal Vascularization - Fanfilcon A Lens (Test) | None | 90.7 percentage of eyes |
| Baseline | Corneal Vascularization - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
| Baseline | Corneal Vascularization - Fanfilcon A Lens (Test) | Trace | 9.3 percentage of eyes |
| Baseline | Corneal Vascularization - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Week 1 | Corneal Vascularization - Fanfilcon A Lens (Test) | Mild | 0.0 percentage of eyes |
| Week 1 | Corneal Vascularization - Fanfilcon A Lens (Test) | Trace | 7.4 percentage of eyes |
| Week 1 | Corneal Vascularization - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Week 1 | Corneal Vascularization - Fanfilcon A Lens (Test) | None | 92.6 percentage of eyes |
| Week 1 | Corneal Vascularization - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
| Week 2 | Corneal Vascularization - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
| Week 2 | Corneal Vascularization - Fanfilcon A Lens (Test) | Trace | 7.5 percentage of eyes |
| Week 2 | Corneal Vascularization - Fanfilcon A Lens (Test) | None | 92.5 percentage of eyes |
| Week 2 | Corneal Vascularization - Fanfilcon A Lens (Test) | Mild | 0.0 percentage of eyes |
| Week 2 | Corneal Vascularization - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Month 1 | Corneal Vascularization - Fanfilcon A Lens (Test) | Mild | 0.0 percentage of eyes |
| Month 1 | Corneal Vascularization - Fanfilcon A Lens (Test) | None | 92.6 percentage of eyes |
| Month 1 | Corneal Vascularization - Fanfilcon A Lens (Test) | Trace | 7.4 percentage of eyes |
| Month 1 | Corneal Vascularization - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Month 1 | Corneal Vascularization - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
| Month 2 | Corneal Vascularization - Fanfilcon A Lens (Test) | None | 94.4 percentage of eyes |
| Month 2 | Corneal Vascularization - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
| Month 2 | Corneal Vascularization - Fanfilcon A Lens (Test) | Mild | 0.0 percentage of eyes |
| Month 2 | Corneal Vascularization - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Month 2 | Corneal Vascularization - Fanfilcon A Lens (Test) | Trace | 5.6 percentage of eyes |
| Month 3 | Corneal Vascularization - Fanfilcon A Lens (Test) | None | 91.7 percentage of eyes |
| Month 3 | Corneal Vascularization - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
| Month 3 | Corneal Vascularization - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Month 3 | Corneal Vascularization - Fanfilcon A Lens (Test) | Trace | 8.3 percentage of eyes |
| Month 3 | Corneal Vascularization - Fanfilcon A Lens (Test) | Mild | 0.0 percentage of eyes |
| Unscheduled | Corneal Vascularization - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Unscheduled | Corneal Vascularization - Fanfilcon A Lens (Test) | Trace | 0.0 percentage of eyes |
| Unscheduled | Corneal Vascularization - Fanfilcon A Lens (Test) | Mild | 0.0 percentage of eyes |
| Unscheduled | Corneal Vascularization - Fanfilcon A Lens (Test) | None | 100.0 percentage of eyes |
| Unscheduled | Corneal Vascularization - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
Epithelial Edema - Enfilcon A Lens (Control)
Epithelial edema is assessed for enfilcon A lens (control). Grading scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Population: All sites, control completed subjects' eyes Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Baseline | Epithelial Edema - Enfilcon A Lens (Control) | None | 100.0 percentage of eyes |
| Baseline | Epithelial Edema - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Baseline | Epithelial Edema - Enfilcon A Lens (Control) | Trace | 0.0 percentage of eyes |
| Baseline | Epithelial Edema - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
| Baseline | Epithelial Edema - Enfilcon A Lens (Control) | MIld | 0.0 percentage of eyes |
| Week 1 | Epithelial Edema - Enfilcon A Lens (Control) | None | 100.0 percentage of eyes |
| Week 1 | Epithelial Edema - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
| Week 1 | Epithelial Edema - Enfilcon A Lens (Control) | MIld | 0.0 percentage of eyes |
| Week 1 | Epithelial Edema - Enfilcon A Lens (Control) | Trace | 0.0 percentage of eyes |
| Week 1 | Epithelial Edema - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Week 2 | Epithelial Edema - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
| Week 2 | Epithelial Edema - Enfilcon A Lens (Control) | MIld | 0.0 percentage of eyes |
| Week 2 | Epithelial Edema - Enfilcon A Lens (Control) | None | 100.0 percentage of eyes |
| Week 2 | Epithelial Edema - Enfilcon A Lens (Control) | Trace | 0.0 percentage of eyes |
| Week 2 | Epithelial Edema - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Month 1 | Epithelial Edema - Enfilcon A Lens (Control) | Trace | 0.0 percentage of eyes |
| Month 1 | Epithelial Edema - Enfilcon A Lens (Control) | MIld | 0.0 percentage of eyes |
| Month 1 | Epithelial Edema - Enfilcon A Lens (Control) | None | 100.0 percentage of eyes |
| Month 1 | Epithelial Edema - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Month 1 | Epithelial Edema - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
| Month 2 | Epithelial Edema - Enfilcon A Lens (Control) | Trace | 0.0 percentage of eyes |
| Month 2 | Epithelial Edema - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
| Month 2 | Epithelial Edema - Enfilcon A Lens (Control) | None | 100.0 percentage of eyes |
| Month 2 | Epithelial Edema - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Month 2 | Epithelial Edema - Enfilcon A Lens (Control) | MIld | 0.0 percentage of eyes |
| Month 3 | Epithelial Edema - Enfilcon A Lens (Control) | Trace | 0.0 percentage of eyes |
| Month 3 | Epithelial Edema - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
| Month 3 | Epithelial Edema - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Month 3 | Epithelial Edema - Enfilcon A Lens (Control) | MIld | 0.0 percentage of eyes |
| Month 3 | Epithelial Edema - Enfilcon A Lens (Control) | None | 100.0 percentage of eyes |
| Unscheduled | Epithelial Edema - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Unscheduled | Epithelial Edema - Enfilcon A Lens (Control) | MIld | 0.0 percentage of eyes |
| Unscheduled | Epithelial Edema - Enfilcon A Lens (Control) | None | 100.0 percentage of eyes |
| Unscheduled | Epithelial Edema - Enfilcon A Lens (Control) | Trace | 0.0 percentage of eyes |
| Unscheduled | Epithelial Edema - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
Epithelial Edema - Fanfilcon A Lens (Test)
Epithelial edema is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Population: All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Baseline | Epithelial Edema - Fanfilcon A Lens (Test) | Mild | 0.0 percentage of eyes |
| Baseline | Epithelial Edema - Fanfilcon A Lens (Test) | None | 100.0 percentage of eyes |
| Baseline | Epithelial Edema - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
| Baseline | Epithelial Edema - Fanfilcon A Lens (Test) | Trace | 0.0 percentage of eyes |
| Baseline | Epithelial Edema - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Week 1 | Epithelial Edema - Fanfilcon A Lens (Test) | Mild | 0.0 percentage of eyes |
| Week 1 | Epithelial Edema - Fanfilcon A Lens (Test) | Trace | 0.0 percentage of eyes |
| Week 1 | Epithelial Edema - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Week 1 | Epithelial Edema - Fanfilcon A Lens (Test) | None | 100.0 percentage of eyes |
| Week 1 | Epithelial Edema - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
| Week 2 | Epithelial Edema - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
| Week 2 | Epithelial Edema - Fanfilcon A Lens (Test) | Trace | 0.9 percentage of eyes |
| Week 2 | Epithelial Edema - Fanfilcon A Lens (Test) | None | 99.1 percentage of eyes |
| Week 2 | Epithelial Edema - Fanfilcon A Lens (Test) | Mild | 0.0 percentage of eyes |
| Week 2 | Epithelial Edema - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Month 1 | Epithelial Edema - Fanfilcon A Lens (Test) | Mild | 0.0 percentage of eyes |
| Month 1 | Epithelial Edema - Fanfilcon A Lens (Test) | None | 100.0 percentage of eyes |
| Month 1 | Epithelial Edema - Fanfilcon A Lens (Test) | Trace | 0.0 percentage of eyes |
| Month 1 | Epithelial Edema - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Month 1 | Epithelial Edema - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
| Month 2 | Epithelial Edema - Fanfilcon A Lens (Test) | None | 100.0 percentage of eyes |
| Month 2 | Epithelial Edema - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
| Month 2 | Epithelial Edema - Fanfilcon A Lens (Test) | Mild | 0.0 percentage of eyes |
| Month 2 | Epithelial Edema - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Month 2 | Epithelial Edema - Fanfilcon A Lens (Test) | Trace | 0.0 percentage of eyes |
| Month 3 | Epithelial Edema - Fanfilcon A Lens (Test) | None | 100.0 percentage of eyes |
| Month 3 | Epithelial Edema - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
| Month 3 | Epithelial Edema - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Month 3 | Epithelial Edema - Fanfilcon A Lens (Test) | Trace | 0.0 percentage of eyes |
| Month 3 | Epithelial Edema - Fanfilcon A Lens (Test) | Mild | 0.0 percentage of eyes |
| Unscheduled | Epithelial Edema - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Unscheduled | Epithelial Edema - Fanfilcon A Lens (Test) | Trace | 0.0 percentage of eyes |
| Unscheduled | Epithelial Edema - Fanfilcon A Lens (Test) | Mild | 0.0 percentage of eyes |
| Unscheduled | Epithelial Edema - Fanfilcon A Lens (Test) | None | 100.0 percentage of eyes |
| Unscheduled | Epithelial Edema - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
Limbal Hyperemia - Enfilcon A Lens (Control)
Limbal hyperemia is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Population: All sites, control completed subjects' eyes Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Baseline | Limbal Hyperemia - Enfilcon A Lens (Control) | Mild | 0.0 percentage of eyes |
| Baseline | Limbal Hyperemia - Enfilcon A Lens (Control) | None | 79.3 percentage of eyes |
| Baseline | Limbal Hyperemia - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
| Baseline | Limbal Hyperemia - Enfilcon A Lens (Control) | Trace | 20.7 percentage of eyes |
| Baseline | Limbal Hyperemia - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Week 1 | Limbal Hyperemia - Enfilcon A Lens (Control) | Mild | 0.0 percentage of eyes |
| Week 1 | Limbal Hyperemia - Enfilcon A Lens (Control) | Trace | 19.2 percentage of eyes |
| Week 1 | Limbal Hyperemia - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Week 1 | Limbal Hyperemia - Enfilcon A Lens (Control) | None | 80.8 percentage of eyes |
| Week 1 | Limbal Hyperemia - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
| Week 2 | Limbal Hyperemia - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
| Week 2 | Limbal Hyperemia - Enfilcon A Lens (Control) | Trace | 6.9 percentage of eyes |
| Week 2 | Limbal Hyperemia - Enfilcon A Lens (Control) | None | 93.1 percentage of eyes |
| Week 2 | Limbal Hyperemia - Enfilcon A Lens (Control) | Mild | 0.0 percentage of eyes |
| Week 2 | Limbal Hyperemia - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Month 1 | Limbal Hyperemia - Enfilcon A Lens (Control) | Mild | 0.0 percentage of eyes |
| Month 1 | Limbal Hyperemia - Enfilcon A Lens (Control) | None | 93.1 percentage of eyes |
| Month 1 | Limbal Hyperemia - Enfilcon A Lens (Control) | Trace | 6.9 percentage of eyes |
| Month 1 | Limbal Hyperemia - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Month 1 | Limbal Hyperemia - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
| Month 2 | Limbal Hyperemia - Enfilcon A Lens (Control) | None | 92.9 percentage of eyes |
| Month 2 | Limbal Hyperemia - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
| Month 2 | Limbal Hyperemia - Enfilcon A Lens (Control) | Mild | 0.0 percentage of eyes |
| Month 2 | Limbal Hyperemia - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Month 2 | Limbal Hyperemia - Enfilcon A Lens (Control) | Trace | 7.1 percentage of eyes |
| Month 3 | Limbal Hyperemia - Enfilcon A Lens (Control) | None | 87.9 percentage of eyes |
| Month 3 | Limbal Hyperemia - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
| Month 3 | Limbal Hyperemia - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Month 3 | Limbal Hyperemia - Enfilcon A Lens (Control) | Trace | 10.3 percentage of eyes |
| Month 3 | Limbal Hyperemia - Enfilcon A Lens (Control) | Mild | 1.7 percentage of eyes |
| Unscheduled | Limbal Hyperemia - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Unscheduled | Limbal Hyperemia - Enfilcon A Lens (Control) | Trace | 0.0 percentage of eyes |
| Unscheduled | Limbal Hyperemia - Enfilcon A Lens (Control) | Mild | 0.0 percentage of eyes |
| Unscheduled | Limbal Hyperemia - Enfilcon A Lens (Control) | None | 100.0 percentage of eyes |
| Unscheduled | Limbal Hyperemia - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
Limbal Hyperemia - Fanfilcon A Lens (Test)
Limbal hyperemia is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Population: All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Baseline | Limbal Hyperemia - Fanfilcon A Lens (Test) | Mild | 0.0 percentage of eyes |
| Baseline | Limbal Hyperemia - Fanfilcon A Lens (Test) | None | 80.6 percentage of eyes |
| Baseline | Limbal Hyperemia - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
| Baseline | Limbal Hyperemia - Fanfilcon A Lens (Test) | Trace | 19.4 percentage of eyes |
| Baseline | Limbal Hyperemia - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Week 1 | Limbal Hyperemia - Fanfilcon A Lens (Test) | Mild | 0.0 percentage of eyes |
| Week 1 | Limbal Hyperemia - Fanfilcon A Lens (Test) | Trace | 11.1 percentage of eyes |
| Week 1 | Limbal Hyperemia - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Week 1 | Limbal Hyperemia - Fanfilcon A Lens (Test) | None | 88.9 percentage of eyes |
| Week 1 | Limbal Hyperemia - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
| Week 2 | Limbal Hyperemia - Fanfilcon A Lens (Test) | Severe | 0 percentage of eyes |
| Week 2 | Limbal Hyperemia - Fanfilcon A Lens (Test) | Trace | 23.6 percentage of eyes |
| Week 2 | Limbal Hyperemia - Fanfilcon A Lens (Test) | None | 76.4 percentage of eyes |
| Week 2 | Limbal Hyperemia - Fanfilcon A Lens (Test) | Mild | 0.0 percentage of eyes |
| Week 2 | Limbal Hyperemia - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Month 1 | Limbal Hyperemia - Fanfilcon A Lens (Test) | Mild | 0.0 percentage of eyes |
| Month 1 | Limbal Hyperemia - Fanfilcon A Lens (Test) | None | 80.6 percentage of eyes |
| Month 1 | Limbal Hyperemia - Fanfilcon A Lens (Test) | Trace | 19.4 percentage of eyes |
| Month 1 | Limbal Hyperemia - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Month 1 | Limbal Hyperemia - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
| Month 2 | Limbal Hyperemia - Fanfilcon A Lens (Test) | None | 82.4 percentage of eyes |
| Month 2 | Limbal Hyperemia - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
| Month 2 | Limbal Hyperemia - Fanfilcon A Lens (Test) | Mild | 0.0 percentage of eyes |
| Month 2 | Limbal Hyperemia - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Month 2 | Limbal Hyperemia - Fanfilcon A Lens (Test) | Trace | 17.6 percentage of eyes |
| Month 3 | Limbal Hyperemia - Fanfilcon A Lens (Test) | None | 75.9 percentage of eyes |
| Month 3 | Limbal Hyperemia - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
| Month 3 | Limbal Hyperemia - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Month 3 | Limbal Hyperemia - Fanfilcon A Lens (Test) | Trace | 23.1 percentage of eyes |
| Month 3 | Limbal Hyperemia - Fanfilcon A Lens (Test) | Mild | 0.9 percentage of eyes |
| Unscheduled | Limbal Hyperemia - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Unscheduled | Limbal Hyperemia - Fanfilcon A Lens (Test) | Trace | 0.0 percentage of eyes |
| Unscheduled | Limbal Hyperemia - Fanfilcon A Lens (Test) | Mild | 0.0 percentage of eyes |
| Unscheduled | Limbal Hyperemia - Fanfilcon A Lens (Test) | None | 100.0 percentage of eyes |
| Unscheduled | Limbal Hyperemia - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
Palpebral Conjunctiva - Enfilcon A Lens (Control)
Palpebral conjunctiva is assessed for enfilcon A lens (control). Grading scale: absent/present
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Population: All sites, control completed subjects' eyes. Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Baseline | Palpebral Conjunctiva - Enfilcon A Lens (Control) | Absent | 55.2 percentage of eyes |
| Baseline | Palpebral Conjunctiva - Enfilcon A Lens (Control) | Present | 44.8 percentage of eyes |
| Week 1 | Palpebral Conjunctiva - Enfilcon A Lens (Control) | Absent | 69.2 percentage of eyes |
| Week 1 | Palpebral Conjunctiva - Enfilcon A Lens (Control) | Present | 30.8 percentage of eyes |
| Week 2 | Palpebral Conjunctiva - Enfilcon A Lens (Control) | Absent | 62.1 percentage of eyes |
| Week 2 | Palpebral Conjunctiva - Enfilcon A Lens (Control) | Present | 37.9 percentage of eyes |
| Month 1 | Palpebral Conjunctiva - Enfilcon A Lens (Control) | Absent | 58.6 percentage of eyes |
| Month 1 | Palpebral Conjunctiva - Enfilcon A Lens (Control) | Present | 41.4 percentage of eyes |
| Month 2 | Palpebral Conjunctiva - Enfilcon A Lens (Control) | Absent | 67.9 percentage of eyes |
| Month 2 | Palpebral Conjunctiva - Enfilcon A Lens (Control) | Present | 32.1 percentage of eyes |
| Month 3 | Palpebral Conjunctiva - Enfilcon A Lens (Control) | Absent | 67.2 percentage of eyes |
| Month 3 | Palpebral Conjunctiva - Enfilcon A Lens (Control) | Present | 32.8 percentage of eyes |
| Unscheduled | Palpebral Conjunctiva - Enfilcon A Lens (Control) | Absent | 66.7 percentage of eyes |
| Unscheduled | Palpebral Conjunctiva - Enfilcon A Lens (Control) | Present | 33.3 percentage of eyes |
Palpebral Conjunctiva - Fanfilcon A Lens (Test)
Palpebral conjunctiva is assessed for fanfilcon A lens (test). Grading scale: Absent/present
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Population: All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Baseline | Palpebral Conjunctiva - Fanfilcon A Lens (Test) | Absent | 69.4 percentage of eyes |
| Baseline | Palpebral Conjunctiva - Fanfilcon A Lens (Test) | Present | 30.6 percentage of eyes |
| Week 1 | Palpebral Conjunctiva - Fanfilcon A Lens (Test) | Absent | 64.8 percentage of eyes |
| Week 1 | Palpebral Conjunctiva - Fanfilcon A Lens (Test) | Present | 35.2 percentage of eyes |
| Week 2 | Palpebral Conjunctiva - Fanfilcon A Lens (Test) | Absent | 63.2 percentage of eyes |
| Week 2 | Palpebral Conjunctiva - Fanfilcon A Lens (Test) | Present | 36.8 percentage of eyes |
| Month 1 | Palpebral Conjunctiva - Fanfilcon A Lens (Test) | Absent | 67.6 percentage of eyes |
| Month 1 | Palpebral Conjunctiva - Fanfilcon A Lens (Test) | Present | 32.4 percentage of eyes |
| Month 2 | Palpebral Conjunctiva - Fanfilcon A Lens (Test) | Absent | 60.2 percentage of eyes |
| Month 2 | Palpebral Conjunctiva - Fanfilcon A Lens (Test) | Present | 39.8 percentage of eyes |
| Month 3 | Palpebral Conjunctiva - Fanfilcon A Lens (Test) | Absent | 58.3 percentage of eyes |
| Month 3 | Palpebral Conjunctiva - Fanfilcon A Lens (Test) | Present | 41.7 percentage of eyes |
| Unscheduled | Palpebral Conjunctiva - Fanfilcon A Lens (Test) | Absent | 50.0 percentage of eyes |
| Unscheduled | Palpebral Conjunctiva - Fanfilcon A Lens (Test) | Present | 50.0 percentage of eyes |
Stromal Edema - Enfilcon A Lens (Control)
Stromal edema is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Population: All sites, control completed subjects' eyes Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Baseline | Stromal Edema - Enfilcon A Lens (Control) | Mild | 0.0 percentage of eyes |
| Baseline | Stromal Edema - Enfilcon A Lens (Control) | None | 100.0 percentage of eyes |
| Baseline | Stromal Edema - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
| Baseline | Stromal Edema - Enfilcon A Lens (Control) | Trace | 0.0 percentage of eyes |
| Baseline | Stromal Edema - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Week 1 | Stromal Edema - Enfilcon A Lens (Control) | Mild | 0.0 percentage of eyes |
| Week 1 | Stromal Edema - Enfilcon A Lens (Control) | Trace | 0.0 percentage of eyes |
| Week 1 | Stromal Edema - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Week 1 | Stromal Edema - Enfilcon A Lens (Control) | None | 100.0 percentage of eyes |
| Week 1 | Stromal Edema - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
| Week 2 | Stromal Edema - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
| Week 2 | Stromal Edema - Enfilcon A Lens (Control) | Trace | 0.0 percentage of eyes |
| Week 2 | Stromal Edema - Enfilcon A Lens (Control) | None | 100.0 percentage of eyes |
| Week 2 | Stromal Edema - Enfilcon A Lens (Control) | Mild | 0.0 percentage of eyes |
| Week 2 | Stromal Edema - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Month 1 | Stromal Edema - Enfilcon A Lens (Control) | Mild | 0.0 percentage of eyes |
| Month 1 | Stromal Edema - Enfilcon A Lens (Control) | None | 100.0 percentage of eyes |
| Month 1 | Stromal Edema - Enfilcon A Lens (Control) | Trace | 0.0 percentage of eyes |
| Month 1 | Stromal Edema - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Month 1 | Stromal Edema - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
| Month 2 | Stromal Edema - Enfilcon A Lens (Control) | None | 100.0 percentage of eyes |
| Month 2 | Stromal Edema - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
| Month 2 | Stromal Edema - Enfilcon A Lens (Control) | Mild | 0.0 percentage of eyes |
| Month 2 | Stromal Edema - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Month 2 | Stromal Edema - Enfilcon A Lens (Control) | Trace | 0.0 percentage of eyes |
| Month 3 | Stromal Edema - Enfilcon A Lens (Control) | None | 100.0 percentage of eyes |
| Month 3 | Stromal Edema - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
| Month 3 | Stromal Edema - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Month 3 | Stromal Edema - Enfilcon A Lens (Control) | Trace | 0.0 percentage of eyes |
| Month 3 | Stromal Edema - Enfilcon A Lens (Control) | Mild | 0.0 percentage of eyes |
| Unscheduled | Stromal Edema - Enfilcon A Lens (Control) | Moderate | 0.0 percentage of eyes |
| Unscheduled | Stromal Edema - Enfilcon A Lens (Control) | Trace | 0.0 percentage of eyes |
| Unscheduled | Stromal Edema - Enfilcon A Lens (Control) | Mild | 0.0 percentage of eyes |
| Unscheduled | Stromal Edema - Enfilcon A Lens (Control) | None | 100.0 percentage of eyes |
| Unscheduled | Stromal Edema - Enfilcon A Lens (Control) | Severe | 0.0 percentage of eyes |
Stromal Edema - Fanfilcon A Lens (Test)
Stromal edema is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Population: All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected during at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Baseline | Stromal Edema - Fanfilcon A Lens (Test) | Mild | 0.0 percentage of eyes |
| Baseline | Stromal Edema - Fanfilcon A Lens (Test) | None | 100.0 percentage of eyes |
| Baseline | Stromal Edema - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
| Baseline | Stromal Edema - Fanfilcon A Lens (Test) | Trace | 0.0 percentage of eyes |
| Baseline | Stromal Edema - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Week 1 | Stromal Edema - Fanfilcon A Lens (Test) | Mild | 0.0 percentage of eyes |
| Week 1 | Stromal Edema - Fanfilcon A Lens (Test) | Trace | 0.0 percentage of eyes |
| Week 1 | Stromal Edema - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Week 1 | Stromal Edema - Fanfilcon A Lens (Test) | None | 100.0 percentage of eyes |
| Week 1 | Stromal Edema - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
| Week 2 | Stromal Edema - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
| Week 2 | Stromal Edema - Fanfilcon A Lens (Test) | Trace | 0.9 percentage of eyes |
| Week 2 | Stromal Edema - Fanfilcon A Lens (Test) | None | 99.1 percentage of eyes |
| Week 2 | Stromal Edema - Fanfilcon A Lens (Test) | Mild | 0.0 percentage of eyes |
| Week 2 | Stromal Edema - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Month 1 | Stromal Edema - Fanfilcon A Lens (Test) | Mild | 0.0 percentage of eyes |
| Month 1 | Stromal Edema - Fanfilcon A Lens (Test) | None | 100.0 percentage of eyes |
| Month 1 | Stromal Edema - Fanfilcon A Lens (Test) | Trace | 0.0 percentage of eyes |
| Month 1 | Stromal Edema - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Month 1 | Stromal Edema - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
| Month 2 | Stromal Edema - Fanfilcon A Lens (Test) | None | 100.0 percentage of eyes |
| Month 2 | Stromal Edema - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
| Month 2 | Stromal Edema - Fanfilcon A Lens (Test) | Mild | 0.0 percentage of eyes |
| Month 2 | Stromal Edema - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Month 2 | Stromal Edema - Fanfilcon A Lens (Test) | Trace | 0.0 percentage of eyes |
| Month 3 | Stromal Edema - Fanfilcon A Lens (Test) | None | 100.0 percentage of eyes |
| Month 3 | Stromal Edema - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
| Month 3 | Stromal Edema - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Month 3 | Stromal Edema - Fanfilcon A Lens (Test) | Trace | 0.0 percentage of eyes |
| Month 3 | Stromal Edema - Fanfilcon A Lens (Test) | Mild | 0.0 percentage of eyes |
| Unscheduled | Stromal Edema - Fanfilcon A Lens (Test) | Moderate | 0.0 percentage of eyes |
| Unscheduled | Stromal Edema - Fanfilcon A Lens (Test) | Trace | 0.0 percentage of eyes |
| Unscheduled | Stromal Edema - Fanfilcon A Lens (Test) | Mild | 0.0 percentage of eyes |
| Unscheduled | Stromal Edema - Fanfilcon A Lens (Test) | None | 100.0 percentage of eyes |
| Unscheduled | Stromal Edema - Fanfilcon A Lens (Test) | Severe | 0.0 percentage of eyes |
Visual Acuity - Enfilcon A Lens (Control)
Visual acuity is assessed for enfilcon A lens (control) using Snellen chart.
Time frame: Week 1, Week 2, Month 1, Month 2, Month 3
Population: All sites, control completed subjects' eyes. Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Baseline | Visual Acuity - Enfilcon A Lens (Control) | 20/15 | 14 eyes |
| Baseline | Visual Acuity - Enfilcon A Lens (Control) | 20/60 | 0 eyes |
| Baseline | Visual Acuity - Enfilcon A Lens (Control) | 20/50 | 0 eyes |
| Baseline | Visual Acuity - Enfilcon A Lens (Control) | 20/25 | 2 eyes |
| Baseline | Visual Acuity - Enfilcon A Lens (Control) | 20/20 | 36 eyes |
| Baseline | Visual Acuity - Enfilcon A Lens (Control) | 20/30 | 0 eyes |
| Baseline | Visual Acuity - Enfilcon A Lens (Control) | 20/40 | 0 eyes |
| Week 1 | Visual Acuity - Enfilcon A Lens (Control) | 20/40 | 0 eyes |
| Week 1 | Visual Acuity - Enfilcon A Lens (Control) | 20/30 | 0 eyes |
| Week 1 | Visual Acuity - Enfilcon A Lens (Control) | 20/20 | 42 eyes |
| Week 1 | Visual Acuity - Enfilcon A Lens (Control) | 20/15 | 14 eyes |
| Week 1 | Visual Acuity - Enfilcon A Lens (Control) | 20/50 | 0 eyes |
| Week 1 | Visual Acuity - Enfilcon A Lens (Control) | 20/25 | 2 eyes |
| Week 1 | Visual Acuity - Enfilcon A Lens (Control) | 20/60 | 0 eyes |
| Week 2 | Visual Acuity - Enfilcon A Lens (Control) | 20/30 | 0 eyes |
| Week 2 | Visual Acuity - Enfilcon A Lens (Control) | 20/15 | 14 eyes |
| Week 2 | Visual Acuity - Enfilcon A Lens (Control) | 20/20 | 42 eyes |
| Week 2 | Visual Acuity - Enfilcon A Lens (Control) | 20/25 | 2 eyes |
| Week 2 | Visual Acuity - Enfilcon A Lens (Control) | 20/40 | 0 eyes |
| Week 2 | Visual Acuity - Enfilcon A Lens (Control) | 20/50 | 0 eyes |
| Week 2 | Visual Acuity - Enfilcon A Lens (Control) | 20/60 | 0 eyes |
| Month 1 | Visual Acuity - Enfilcon A Lens (Control) | 20/25 | 2 eyes |
| Month 1 | Visual Acuity - Enfilcon A Lens (Control) | 20/40 | 0 eyes |
| Month 1 | Visual Acuity - Enfilcon A Lens (Control) | 20/20 | 40 eyes |
| Month 1 | Visual Acuity - Enfilcon A Lens (Control) | 20/60 | 0 eyes |
| Month 1 | Visual Acuity - Enfilcon A Lens (Control) | 20/50 | 0 eyes |
| Month 1 | Visual Acuity - Enfilcon A Lens (Control) | 20/15 | 14 eyes |
| Month 1 | Visual Acuity - Enfilcon A Lens (Control) | 20/30 | 0 eyes |
| Month 2 | Visual Acuity - Enfilcon A Lens (Control) | 20/25 | 2 eyes |
| Month 2 | Visual Acuity - Enfilcon A Lens (Control) | 20/60 | 0 eyes |
| Month 2 | Visual Acuity - Enfilcon A Lens (Control) | 20/50 | 0 eyes |
| Month 2 | Visual Acuity - Enfilcon A Lens (Control) | 20/40 | 0 eyes |
| Month 2 | Visual Acuity - Enfilcon A Lens (Control) | 20/20 | 42 eyes |
| Month 2 | Visual Acuity - Enfilcon A Lens (Control) | 20/15 | 14 eyes |
| Month 2 | Visual Acuity - Enfilcon A Lens (Control) | 20/30 | 0 eyes |
Visual Acuity - Fanfilcon A Lens (Test)
Visual acuity is assessed for fanfilcon A lens (test) using Snellen chart.
Time frame: Week 1, Week 2, Month 1, Month 2, Month 3
Population: All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected at 2 week visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Baseline | Visual Acuity - Fanfilcon A Lens (Test) | 20/15 | 27 eyes |
| Baseline | Visual Acuity - Fanfilcon A Lens (Test) | 20/60 | 0 eyes |
| Baseline | Visual Acuity - Fanfilcon A Lens (Test) | 20/50 | 0 eyes |
| Baseline | Visual Acuity - Fanfilcon A Lens (Test) | 20/25 | 3 eyes |
| Baseline | Visual Acuity - Fanfilcon A Lens (Test) | 20/20 | 78 eyes |
| Baseline | Visual Acuity - Fanfilcon A Lens (Test) | 20/30 | 0 eyes |
| Baseline | Visual Acuity - Fanfilcon A Lens (Test) | 20/40 | 0 eyes |
| Week 1 | Visual Acuity - Fanfilcon A Lens (Test) | 20/40 | 0 eyes |
| Week 1 | Visual Acuity - Fanfilcon A Lens (Test) | 20/30 | 0 eyes |
| Week 1 | Visual Acuity - Fanfilcon A Lens (Test) | 20/20 | 77 eyes |
| Week 1 | Visual Acuity - Fanfilcon A Lens (Test) | 20/15 | 26 eyes |
| Week 1 | Visual Acuity - Fanfilcon A Lens (Test) | 20/50 | 0 eyes |
| Week 1 | Visual Acuity - Fanfilcon A Lens (Test) | 20/25 | 3 eyes |
| Week 1 | Visual Acuity - Fanfilcon A Lens (Test) | 20/60 | 0 eyes |
| Week 2 | Visual Acuity - Fanfilcon A Lens (Test) | 20/30 | 0 eyes |
| Week 2 | Visual Acuity - Fanfilcon A Lens (Test) | 20/15 | 27 eyes |
| Week 2 | Visual Acuity - Fanfilcon A Lens (Test) | 20/20 | 78 eyes |
| Week 2 | Visual Acuity - Fanfilcon A Lens (Test) | 20/25 | 3 eyes |
| Week 2 | Visual Acuity - Fanfilcon A Lens (Test) | 20/40 | 0 eyes |
| Week 2 | Visual Acuity - Fanfilcon A Lens (Test) | 20/50 | 0 eyes |
| Week 2 | Visual Acuity - Fanfilcon A Lens (Test) | 20/60 | 0 eyes |
| Month 1 | Visual Acuity - Fanfilcon A Lens (Test) | 20/25 | 3 eyes |
| Month 1 | Visual Acuity - Fanfilcon A Lens (Test) | 20/40 | 0 eyes |
| Month 1 | Visual Acuity - Fanfilcon A Lens (Test) | 20/20 | 78 eyes |
| Month 1 | Visual Acuity - Fanfilcon A Lens (Test) | 20/60 | 0 eyes |
| Month 1 | Visual Acuity - Fanfilcon A Lens (Test) | 20/50 | 0 eyes |
| Month 1 | Visual Acuity - Fanfilcon A Lens (Test) | 20/15 | 27 eyes |
| Month 1 | Visual Acuity - Fanfilcon A Lens (Test) | 20/30 | 0 eyes |
| Month 2 | Visual Acuity - Fanfilcon A Lens (Test) | 20/25 | 3 eyes |
| Month 2 | Visual Acuity - Fanfilcon A Lens (Test) | 20/60 | 0 eyes |
| Month 2 | Visual Acuity - Fanfilcon A Lens (Test) | 20/50 | 0 eyes |
| Month 2 | Visual Acuity - Fanfilcon A Lens (Test) | 20/40 | 0 eyes |
| Month 2 | Visual Acuity - Fanfilcon A Lens (Test) | 20/20 | 78 eyes |
| Month 2 | Visual Acuity - Fanfilcon A Lens (Test) | 20/15 | 27 eyes |
| Month 2 | Visual Acuity - Fanfilcon A Lens (Test) | 20/30 | 0 eyes |
Comfort - Enfilcon A Lens (Control)
Enfilcon A lens (control) are assessed regarding comfort for the following: comfort upon insertion (CUI), comfort during the day (CDD), end of the day comfort (EDC), overall comfort (OC), and comfort at visit (CV). Subjects were asked to rate comfort from 0-5 (0=excellent, 1=very comfortable, 2=comfortable, 3=slightly uncomfortable, 4=very uncomfortable, or 5=causes pain).
Time frame: Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months follow-up
Population: All sites, control completed subjects. Three subjects data was not collected during Week 1 visit. One subject data was not collected during Month 2 visit.~Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Baseline | Comfort - Enfilcon A Lens (Control) | OC - very uncomfortable | 0 eyes |
| Baseline | Comfort - Enfilcon A Lens (Control) | CUI - comfortable | 6 eyes |
| Baseline | Comfort - Enfilcon A Lens (Control) | CDD - comfortable | 12 eyes |
| Baseline | Comfort - Enfilcon A Lens (Control) | EDC - very uncomfortable | 6 eyes |
| Baseline | Comfort - Enfilcon A Lens (Control) | CV - very comfortable | 16 eyes |
| Baseline | Comfort - Enfilcon A Lens (Control) | CUI - causes pain | 0 eyes |
| Baseline | Comfort - Enfilcon A Lens (Control) | OC - very comfortable | 24 eyes |
| Baseline | Comfort - Enfilcon A Lens (Control) | CUI - excellent | 20 eyes |
| Baseline | Comfort - Enfilcon A Lens (Control) | CV - causes pain | 0 eyes |
| Baseline | Comfort - Enfilcon A Lens (Control) | CDD - very comfortable | 18 eyes |
| Baseline | Comfort - Enfilcon A Lens (Control) | EDC - causes pain | 0 eyes |
| Baseline | Comfort - Enfilcon A Lens (Control) | CV - excellent | 22 eyes |
| Baseline | Comfort - Enfilcon A Lens (Control) | CDD - excellent | 26 eyes |
| Baseline | Comfort - Enfilcon A Lens (Control) | EDC - slightly uncomfortable | 10 eyes |
| Baseline | Comfort - Enfilcon A Lens (Control) | OC - causes pain | 0 eyes |
| Baseline | Comfort - Enfilcon A Lens (Control) | CUI - very comfortable | 26 eyes |
| Baseline | Comfort - Enfilcon A Lens (Control) | CDD - causes pain | 0 eyes |
| Baseline | Comfort - Enfilcon A Lens (Control) | CV - very uncomfortable | 0 eyes |
| Baseline | Comfort - Enfilcon A Lens (Control) | OC- comfortable | 10 eyes |
| Baseline | Comfort - Enfilcon A Lens (Control) | EDC - very comfortable | 12 eyes |
| Baseline | Comfort - Enfilcon A Lens (Control) | CV - slightly uncomfortable | 8 eyes |
| Baseline | Comfort - Enfilcon A Lens (Control) | CUI- slightly uncomfortable | 6 eyes |
| Baseline | Comfort - Enfilcon A Lens (Control) | EDC - comfortable | 14 eyes |
| Baseline | Comfort - Enfilcon A Lens (Control) | CDD-very uncomfortable | 0 eyes |
| Baseline | Comfort - Enfilcon A Lens (Control) | OC - slightly uncomfortable | 4 eyes |
| Baseline | Comfort - Enfilcon A Lens (Control) | CDD - slightly uncomfortable | 2 eyes |
| Baseline | Comfort - Enfilcon A Lens (Control) | OC - excellent | 20 eyes |
| Baseline | Comfort - Enfilcon A Lens (Control) | CV - comfortable | 12 eyes |
| Baseline | Comfort - Enfilcon A Lens (Control) | CUI - very uncomfortable | 0 eyes |
| Baseline | Comfort - Enfilcon A Lens (Control) | EDC - excellent | 16 eyes |
| Week 1 | Comfort - Enfilcon A Lens (Control) | CDD - causes pain | 0 eyes |
| Week 1 | Comfort - Enfilcon A Lens (Control) | EDC - very comfortable | 14 eyes |
| Week 1 | Comfort - Enfilcon A Lens (Control) | EDC - very uncomfortable | 2 eyes |
| Week 1 | Comfort - Enfilcon A Lens (Control) | EDC - comfortable | 10 eyes |
| Week 1 | Comfort - Enfilcon A Lens (Control) | CUI - comfortable | 6 eyes |
| Week 1 | Comfort - Enfilcon A Lens (Control) | EDC - slightly uncomfortable | 14 eyes |
| Week 1 | Comfort - Enfilcon A Lens (Control) | CUI - excellent | 16 eyes |
| Week 1 | Comfort - Enfilcon A Lens (Control) | CV - slightly uncomfortable | 2 eyes |
| Week 1 | Comfort - Enfilcon A Lens (Control) | CUI- slightly uncomfortable | 7 eyes |
| Week 1 | Comfort - Enfilcon A Lens (Control) | CV - comfortable | 8 eyes |
| Week 1 | Comfort - Enfilcon A Lens (Control) | CUI - very uncomfortable | 0 eyes |
| Week 1 | Comfort - Enfilcon A Lens (Control) | CV - causes pain | 0 eyes |
| Week 1 | Comfort - Enfilcon A Lens (Control) | CV - very comfortable | 14 eyes |
| Week 1 | Comfort - Enfilcon A Lens (Control) | CUI - causes pain | 0 eyes |
| Week 1 | Comfort - Enfilcon A Lens (Control) | CV - excellent | 28 eyes |
| Week 1 | Comfort - Enfilcon A Lens (Control) | CDD - excellent | 22 eyes |
| Week 1 | Comfort - Enfilcon A Lens (Control) | OC - causes pain | 0 eyes |
| Week 1 | Comfort - Enfilcon A Lens (Control) | CDD - very comfortable | 15 eyes |
| Week 1 | Comfort - Enfilcon A Lens (Control) | CUI - very comfortable | 23 eyes |
| Week 1 | Comfort - Enfilcon A Lens (Control) | OC - very uncomfortable | 0 eyes |
| Week 1 | Comfort - Enfilcon A Lens (Control) | CDD - comfortable | 12 eyes |
| Week 1 | Comfort - Enfilcon A Lens (Control) | OC - slightly uncomfortable | 10 eyes |
| Week 1 | Comfort - Enfilcon A Lens (Control) | CDD - slightly uncomfortable | 3 eyes |
| Week 1 | Comfort - Enfilcon A Lens (Control) | OC- comfortable | 10 eyes |
| Week 1 | Comfort - Enfilcon A Lens (Control) | CDD-very uncomfortable | 0 eyes |
| Week 1 | Comfort - Enfilcon A Lens (Control) | OC - very comfortable | 16 eyes |
| Week 1 | Comfort - Enfilcon A Lens (Control) | EDC - causes pain | 0 eyes |
| Week 1 | Comfort - Enfilcon A Lens (Control) | CV - very uncomfortable | 0 eyes |
| Week 1 | Comfort - Enfilcon A Lens (Control) | OC - excellent | 16 eyes |
| Week 1 | Comfort - Enfilcon A Lens (Control) | EDC - excellent | 12 eyes |
| Week 2 | Comfort - Enfilcon A Lens (Control) | CUI - very uncomfortable | 0 eyes |
| Week 2 | Comfort - Enfilcon A Lens (Control) | OC - slightly uncomfortable | 3 eyes |
| Week 2 | Comfort - Enfilcon A Lens (Control) | EDC - slightly uncomfortable | 7 eyes |
| Week 2 | Comfort - Enfilcon A Lens (Control) | CV - comfortable | 16 eyes |
| Week 2 | Comfort - Enfilcon A Lens (Control) | OC - excellent | 20 eyes |
| Week 2 | Comfort - Enfilcon A Lens (Control) | CDD - slightly uncomfortable | 2 eyes |
| Week 2 | Comfort - Enfilcon A Lens (Control) | CUI - excellent | 30 eyes |
| Week 2 | Comfort - Enfilcon A Lens (Control) | CV - causes pain | 0 eyes |
| Week 2 | Comfort - Enfilcon A Lens (Control) | OC- comfortable | 16 eyes |
| Week 2 | Comfort - Enfilcon A Lens (Control) | EDC - very comfortable | 5 eyes |
| Week 2 | Comfort - Enfilcon A Lens (Control) | CUI- slightly uncomfortable | 0 eyes |
| Week 2 | Comfort - Enfilcon A Lens (Control) | EDC - comfortable | 24 eyes |
| Week 2 | Comfort - Enfilcon A Lens (Control) | CDD-very uncomfortable | 0 eyes |
| Week 2 | Comfort - Enfilcon A Lens (Control) | CV - very uncomfortable | 0 eyes |
| Week 2 | Comfort - Enfilcon A Lens (Control) | CV - slightly uncomfortable | 2 eyes |
| Week 2 | Comfort - Enfilcon A Lens (Control) | OC - very comfortable | 19 eyes |
| Week 2 | Comfort - Enfilcon A Lens (Control) | OC - causes pain | 0 eyes |
| Week 2 | Comfort - Enfilcon A Lens (Control) | EDC - causes pain | 0 eyes |
| Week 2 | Comfort - Enfilcon A Lens (Control) | CDD - excellent | 24 eyes |
| Week 2 | Comfort - Enfilcon A Lens (Control) | CV - excellent | 32 eyes |
| Week 2 | Comfort - Enfilcon A Lens (Control) | CUI - comfortable | 12 eyes |
| Week 2 | Comfort - Enfilcon A Lens (Control) | CDD - very comfortable | 13 eyes |
| Week 2 | Comfort - Enfilcon A Lens (Control) | EDC - excellent | 22 eyes |
| Week 2 | Comfort - Enfilcon A Lens (Control) | CUI - causes pain | 0 eyes |
| Week 2 | Comfort - Enfilcon A Lens (Control) | OC - very uncomfortable | 0 eyes |
| Week 2 | Comfort - Enfilcon A Lens (Control) | CDD - causes pain | 0 eyes |
| Week 2 | Comfort - Enfilcon A Lens (Control) | CV - very comfortable | 8 eyes |
| Week 2 | Comfort - Enfilcon A Lens (Control) | EDC - very uncomfortable | 0 eyes |
| Week 2 | Comfort - Enfilcon A Lens (Control) | CDD - comfortable | 19 eyes |
| Week 2 | Comfort - Enfilcon A Lens (Control) | CUI - very comfortable | 16 eyes |
| Month 1 | Comfort - Enfilcon A Lens (Control) | OC - very uncomfortable | 0 eyes |
| Month 1 | Comfort - Enfilcon A Lens (Control) | CUI - excellent | 20 eyes |
| Month 1 | Comfort - Enfilcon A Lens (Control) | CUI - very comfortable | 24 eyes |
| Month 1 | Comfort - Enfilcon A Lens (Control) | CUI - comfortable | 11 eyes |
| Month 1 | Comfort - Enfilcon A Lens (Control) | CUI- slightly uncomfortable | 3 eyes |
| Month 1 | Comfort - Enfilcon A Lens (Control) | CUI - very uncomfortable | 0 eyes |
| Month 1 | Comfort - Enfilcon A Lens (Control) | CUI - causes pain | 0 eyes |
| Month 1 | Comfort - Enfilcon A Lens (Control) | CDD - excellent | 18 eyes |
| Month 1 | Comfort - Enfilcon A Lens (Control) | CDD - very comfortable | 10 eyes |
| Month 1 | Comfort - Enfilcon A Lens (Control) | CDD - comfortable | 20 eyes |
| Month 1 | Comfort - Enfilcon A Lens (Control) | CDD - slightly uncomfortable | 10 eyes |
| Month 1 | Comfort - Enfilcon A Lens (Control) | CDD-very uncomfortable | 0 eyes |
| Month 1 | Comfort - Enfilcon A Lens (Control) | CDD - causes pain | 0 eyes |
| Month 1 | Comfort - Enfilcon A Lens (Control) | EDC - excellent | 14 eyes |
| Month 1 | Comfort - Enfilcon A Lens (Control) | EDC - very comfortable | 8 eyes |
| Month 1 | Comfort - Enfilcon A Lens (Control) | EDC - comfortable | 20 eyes |
| Month 1 | Comfort - Enfilcon A Lens (Control) | EDC - slightly uncomfortable | 12 eyes |
| Month 1 | Comfort - Enfilcon A Lens (Control) | EDC - very uncomfortable | 4 eyes |
| Month 1 | Comfort - Enfilcon A Lens (Control) | EDC - causes pain | 0 eyes |
| Month 1 | Comfort - Enfilcon A Lens (Control) | OC - excellent | 18 eyes |
| Month 1 | Comfort - Enfilcon A Lens (Control) | OC - very comfortable | 12 eyes |
| Month 1 | Comfort - Enfilcon A Lens (Control) | OC- comfortable | 22 eyes |
| Month 1 | Comfort - Enfilcon A Lens (Control) | OC - slightly uncomfortable | 6 eyes |
| Month 1 | Comfort - Enfilcon A Lens (Control) | OC - causes pain | 0 eyes |
| Month 1 | Comfort - Enfilcon A Lens (Control) | CV - excellent | 26 eyes |
| Month 1 | Comfort - Enfilcon A Lens (Control) | CV - very comfortable | 16 eyes |
| Month 1 | Comfort - Enfilcon A Lens (Control) | CV - comfortable | 14 eyes |
| Month 1 | Comfort - Enfilcon A Lens (Control) | CV - slightly uncomfortable | 2 eyes |
| Month 1 | Comfort - Enfilcon A Lens (Control) | CV - very uncomfortable | 0 eyes |
| Month 1 | Comfort - Enfilcon A Lens (Control) | CV - causes pain | 0 eyes |
| Month 2 | Comfort - Enfilcon A Lens (Control) | CUI- slightly uncomfortable | 4 eyes |
| Month 2 | Comfort - Enfilcon A Lens (Control) | OC - slightly uncomfortable | 6 eyes |
| Month 2 | Comfort - Enfilcon A Lens (Control) | EDC - comfortable | 15 eyes |
| Month 2 | Comfort - Enfilcon A Lens (Control) | CV - very comfortable | 8 eyes |
| Month 2 | Comfort - Enfilcon A Lens (Control) | CDD - comfortable | 13 eyes |
| Month 2 | Comfort - Enfilcon A Lens (Control) | CUI - excellent | 28 eyes |
| Month 2 | Comfort - Enfilcon A Lens (Control) | CDD - causes pain | 0 eyes |
| Month 2 | Comfort - Enfilcon A Lens (Control) | CDD - very comfortable | 17 eyes |
| Month 2 | Comfort - Enfilcon A Lens (Control) | OC - very uncomfortable | 0 eyes |
| Month 2 | Comfort - Enfilcon A Lens (Control) | EDC - slightly uncomfortable | 8 eyes |
| Month 2 | Comfort - Enfilcon A Lens (Control) | CUI - very uncomfortable | 0 eyes |
| Month 2 | Comfort - Enfilcon A Lens (Control) | CV - excellent | 32 eyes |
| Month 2 | Comfort - Enfilcon A Lens (Control) | EDC - excellent | 16 eyes |
| Month 2 | Comfort - Enfilcon A Lens (Control) | CDD - excellent | 22 eyes |
| Month 2 | Comfort - Enfilcon A Lens (Control) | CUI - causes pain | 0 eyes |
| Month 2 | Comfort - Enfilcon A Lens (Control) | OC - causes pain | 0 eyes |
| Month 2 | Comfort - Enfilcon A Lens (Control) | CV - very uncomfortable | 0 eyes |
| Month 2 | Comfort - Enfilcon A Lens (Control) | OC - very comfortable | 12 eyes |
| Month 2 | Comfort - Enfilcon A Lens (Control) | EDC - very uncomfortable | 2 eyes |
| Month 2 | Comfort - Enfilcon A Lens (Control) | CV - slightly uncomfortable | 4 eyes |
| Month 2 | Comfort - Enfilcon A Lens (Control) | CDD-very uncomfortable | 0 eyes |
| Month 2 | Comfort - Enfilcon A Lens (Control) | CV - causes pain | 0 eyes |
| Month 2 | Comfort - Enfilcon A Lens (Control) | EDC - causes pain | 0 eyes |
| Month 2 | Comfort - Enfilcon A Lens (Control) | CUI - very comfortable | 12 eyes |
| Month 2 | Comfort - Enfilcon A Lens (Control) | OC- comfortable | 14 eyes |
| Month 2 | Comfort - Enfilcon A Lens (Control) | OC - excellent | 24 eyes |
| Month 2 | Comfort - Enfilcon A Lens (Control) | CUI - comfortable | 12 eyes |
| Month 2 | Comfort - Enfilcon A Lens (Control) | CDD - slightly uncomfortable | 4 eyes |
| Month 2 | Comfort - Enfilcon A Lens (Control) | CV - comfortable | 12 eyes |
| Month 2 | Comfort - Enfilcon A Lens (Control) | EDC - very comfortable | 15 eyes |
| Month 3 | Comfort - Enfilcon A Lens (Control) | CV - comfortable | 11 eyes |
| Month 3 | Comfort - Enfilcon A Lens (Control) | EDC - excellent | 14 eyes |
| Month 3 | Comfort - Enfilcon A Lens (Control) | EDC - causes pain | 0 eyes |
| Month 3 | Comfort - Enfilcon A Lens (Control) | CDD - causes pain | 0 eyes |
| Month 3 | Comfort - Enfilcon A Lens (Control) | CV - causes pain | 0 eyes |
| Month 3 | Comfort - Enfilcon A Lens (Control) | OC - excellent | 18 eyes |
| Month 3 | Comfort - Enfilcon A Lens (Control) | CDD-very uncomfortable | 2 eyes |
| Month 3 | Comfort - Enfilcon A Lens (Control) | OC - very comfortable | 16 eyes |
| Month 3 | Comfort - Enfilcon A Lens (Control) | CDD - slightly uncomfortable | 9 eyes |
| Month 3 | Comfort - Enfilcon A Lens (Control) | CV - very uncomfortable | 0 eyes |
| Month 3 | Comfort - Enfilcon A Lens (Control) | OC- comfortable | 16 eyes |
| Month 3 | Comfort - Enfilcon A Lens (Control) | CDD - comfortable | 10 eyes |
| Month 3 | Comfort - Enfilcon A Lens (Control) | OC - slightly uncomfortable | 6 eyes |
| Month 3 | Comfort - Enfilcon A Lens (Control) | CDD - very comfortable | 18 eyes |
| Month 3 | Comfort - Enfilcon A Lens (Control) | OC - very uncomfortable | 2 eyes |
| Month 3 | Comfort - Enfilcon A Lens (Control) | CDD - excellent | 19 eyes |
| Month 3 | Comfort - Enfilcon A Lens (Control) | OC - causes pain | 0 eyes |
| Month 3 | Comfort - Enfilcon A Lens (Control) | CUI - causes pain | 0 eyes |
| Month 3 | Comfort - Enfilcon A Lens (Control) | CUI - excellent | 26 eyes |
| Month 3 | Comfort - Enfilcon A Lens (Control) | CV - excellent | 22 eyes |
| Month 3 | Comfort - Enfilcon A Lens (Control) | CUI - very uncomfortable | 0 eyes |
| Month 3 | Comfort - Enfilcon A Lens (Control) | CV - very comfortable | 22 eyes |
| Month 3 | Comfort - Enfilcon A Lens (Control) | CUI- slightly uncomfortable | 2 eyes |
| Month 3 | Comfort - Enfilcon A Lens (Control) | CUI - comfortable | 12 eyes |
| Month 3 | Comfort - Enfilcon A Lens (Control) | CV - slightly uncomfortable | 3 eyes |
| Month 3 | Comfort - Enfilcon A Lens (Control) | EDC - comfortable | 10 eyes |
| Month 3 | Comfort - Enfilcon A Lens (Control) | EDC - slightly uncomfortable | 19 eyes |
| Month 3 | Comfort - Enfilcon A Lens (Control) | EDC - very comfortable | 12 eyes |
| Month 3 | Comfort - Enfilcon A Lens (Control) | CUI - very comfortable | 18 eyes |
| Month 3 | Comfort - Enfilcon A Lens (Control) | EDC - very uncomfortable | 3 eyes |
| Unscheduled | Comfort - Enfilcon A Lens (Control) | EDC - slightly uncomfortable | 0 eyes |
| Unscheduled | Comfort - Enfilcon A Lens (Control) | CV - very comfortable | 0 eyes |
| Unscheduled | Comfort - Enfilcon A Lens (Control) | CUI- slightly uncomfortable | 0 eyes |
| Unscheduled | Comfort - Enfilcon A Lens (Control) | OC - excellent | 4 eyes |
| Unscheduled | Comfort - Enfilcon A Lens (Control) | CV - very uncomfortable | 0 eyes |
| Unscheduled | Comfort - Enfilcon A Lens (Control) | CV - causes pain | 0 eyes |
| Unscheduled | Comfort - Enfilcon A Lens (Control) | CDD - comfortable | 0 eyes |
| Unscheduled | Comfort - Enfilcon A Lens (Control) | EDC - excellent | 6 eyes |
| Unscheduled | Comfort - Enfilcon A Lens (Control) | CV - comfortable | 2 eyes |
| Unscheduled | Comfort - Enfilcon A Lens (Control) | CUI - comfortable | 0 eyes |
| Unscheduled | Comfort - Enfilcon A Lens (Control) | EDC - very comfortable | 0 eyes |
| Unscheduled | Comfort - Enfilcon A Lens (Control) | OC- comfortable | 0 eyes |
| Unscheduled | Comfort - Enfilcon A Lens (Control) | CDD - slightly uncomfortable | 0 eyes |
| Unscheduled | Comfort - Enfilcon A Lens (Control) | OC - very comfortable | 2 eyes |
| Unscheduled | Comfort - Enfilcon A Lens (Control) | EDC - causes pain | 0 eyes |
| Unscheduled | Comfort - Enfilcon A Lens (Control) | CV - slightly uncomfortable | 0 eyes |
| Unscheduled | Comfort - Enfilcon A Lens (Control) | EDC - comfortable | 0 eyes |
| Unscheduled | Comfort - Enfilcon A Lens (Control) | OC - causes pain | 0 eyes |
| Unscheduled | Comfort - Enfilcon A Lens (Control) | CUI - causes pain | 0 eyes |
| Unscheduled | Comfort - Enfilcon A Lens (Control) | EDC - very uncomfortable | 0 eyes |
| Unscheduled | Comfort - Enfilcon A Lens (Control) | CUI - excellent | 6 eyes |
| Unscheduled | Comfort - Enfilcon A Lens (Control) | CUI - very comfortable | 0 eyes |
| Unscheduled | Comfort - Enfilcon A Lens (Control) | CDD - excellent | 6 eyes |
| Unscheduled | Comfort - Enfilcon A Lens (Control) | CDD-very uncomfortable | 0 eyes |
| Unscheduled | Comfort - Enfilcon A Lens (Control) | CV - excellent | 4 eyes |
| Unscheduled | Comfort - Enfilcon A Lens (Control) | CUI - very uncomfortable | 0 eyes |
| Unscheduled | Comfort - Enfilcon A Lens (Control) | CDD - causes pain | 0 eyes |
| Unscheduled | Comfort - Enfilcon A Lens (Control) | OC - very uncomfortable | 0 eyes |
| Unscheduled | Comfort - Enfilcon A Lens (Control) | CDD - very comfortable | 0 eyes |
| Unscheduled | Comfort - Enfilcon A Lens (Control) | OC - slightly uncomfortable | 0 eyes |
Comfort - Fanfilcon A Lens (Test)
Fanfilcon A lens (test) are assessed regarding comfort for the following: comfort upon insertion (CUI), comfort during the day (CDD), end of the day comfort (EDC), overall comfort (OC), and comfort at visit (CV). Subjects were asked to rate comfort from 0-5 (0=excellent, 1=very comfortable, 2=comfortable, 3=slightly uncomfortable, 4=very uncomfortable, or 5=causes pain).
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Population: All sites, test subjects' completed eyes. One subject data was not collected at 2 week visit.~Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Baseline | Comfort - Fanfilcon A Lens (Test) | OC - very uncomfortable | 0 Eyes |
| Baseline | Comfort - Fanfilcon A Lens (Test) | CUI - comfortable | 15 Eyes |
| Baseline | Comfort - Fanfilcon A Lens (Test) | CDD - comfortable | 19 Eyes |
| Baseline | Comfort - Fanfilcon A Lens (Test) | EDC - very uncomfortable | 2 Eyes |
| Baseline | Comfort - Fanfilcon A Lens (Test) | CV - very comfortable | 22 Eyes |
| Baseline | Comfort - Fanfilcon A Lens (Test) | CUI - causes pain | 0 Eyes |
| Baseline | Comfort - Fanfilcon A Lens (Test) | OC - very comfortable | 47 Eyes |
| Baseline | Comfort - Fanfilcon A Lens (Test) | CUI - excellent | 50 Eyes |
| Baseline | Comfort - Fanfilcon A Lens (Test) | CV - causes pain | 0 Eyes |
| Baseline | Comfort - Fanfilcon A Lens (Test) | CDD - very comfortable | 38 Eyes |
| Baseline | Comfort - Fanfilcon A Lens (Test) | EDC - causes pain | 0 Eyes |
| Baseline | Comfort - Fanfilcon A Lens (Test) | CV - excellent | 60 Eyes |
| Baseline | Comfort - Fanfilcon A Lens (Test) | CDD - excellent | 45 Eyes |
| Baseline | Comfort - Fanfilcon A Lens (Test) | EDC - slightly uncomfortable | 19 Eyes |
| Baseline | Comfort - Fanfilcon A Lens (Test) | OC - causes pain | 0 Eyes |
| Baseline | Comfort - Fanfilcon A Lens (Test) | CUI - very comfortable | 40 Eyes |
| Baseline | Comfort - Fanfilcon A Lens (Test) | CDD - causes pain | 0 Eyes |
| Baseline | Comfort - Fanfilcon A Lens (Test) | CV - very uncomfortable | 2 Eyes |
| Baseline | Comfort - Fanfilcon A Lens (Test) | OC - comfortable | 20 Eyes |
| Baseline | Comfort - Fanfilcon A Lens (Test) | EDC - very comfortable | 46 Eyes |
| Baseline | Comfort - Fanfilcon A Lens (Test) | CV - slightly uncomfortable | 7 Eyes |
| Baseline | Comfort - Fanfilcon A Lens (Test) | CUI- slightly uncomfortable | 3 Eyes |
| Baseline | Comfort - Fanfilcon A Lens (Test) | EDC - comfortable | 27 Eyes |
| Baseline | Comfort - Fanfilcon A Lens (Test) | CDD-very uncomfortable | 0 Eyes |
| Baseline | Comfort - Fanfilcon A Lens (Test) | OC - slightly uncomfortable | 4 Eyes |
| Baseline | Comfort - Fanfilcon A Lens (Test) | CDD - slightly uncomfortable | 6 Eyes |
| Baseline | Comfort - Fanfilcon A Lens (Test) | OC - excellent | 37 Eyes |
| Baseline | Comfort - Fanfilcon A Lens (Test) | CV - comfortable | 17 Eyes |
| Baseline | Comfort - Fanfilcon A Lens (Test) | CUI - very uncomfortable | 0 Eyes |
| Baseline | Comfort - Fanfilcon A Lens (Test) | EDC - excellent | 14 Eyes |
| Week 1 | Comfort - Fanfilcon A Lens (Test) | CDD - causes pain | 0 Eyes |
| Week 1 | Comfort - Fanfilcon A Lens (Test) | EDC - very comfortable | 34 Eyes |
| Week 1 | Comfort - Fanfilcon A Lens (Test) | EDC - very uncomfortable | 2 Eyes |
| Week 1 | Comfort - Fanfilcon A Lens (Test) | EDC - comfortable | 32 Eyes |
| Week 1 | Comfort - Fanfilcon A Lens (Test) | CUI - comfortable | 6 Eyes |
| Week 1 | Comfort - Fanfilcon A Lens (Test) | EDC - slightly uncomfortable | 8 Eyes |
| Week 1 | Comfort - Fanfilcon A Lens (Test) | CUI - excellent | 50 Eyes |
| Week 1 | Comfort - Fanfilcon A Lens (Test) | CV - slightly uncomfortable | 0 Eyes |
| Week 1 | Comfort - Fanfilcon A Lens (Test) | CUI- slightly uncomfortable | 2 Eyes |
| Week 1 | Comfort - Fanfilcon A Lens (Test) | CV - comfortable | 12 Eyes |
| Week 1 | Comfort - Fanfilcon A Lens (Test) | CUI - very uncomfortable | 0 Eyes |
| Week 1 | Comfort - Fanfilcon A Lens (Test) | CV - causes pain | 0 Eyes |
| Week 1 | Comfort - Fanfilcon A Lens (Test) | CV - very comfortable | 36 Eyes |
| Week 1 | Comfort - Fanfilcon A Lens (Test) | CUI - causes pain | 0 Eyes |
| Week 1 | Comfort - Fanfilcon A Lens (Test) | CV - excellent | 60 Eyes |
| Week 1 | Comfort - Fanfilcon A Lens (Test) | CDD - excellent | 45 Eyes |
| Week 1 | Comfort - Fanfilcon A Lens (Test) | OC - causes pain | 0 Eyes |
| Week 1 | Comfort - Fanfilcon A Lens (Test) | CDD - very comfortable | 50 Eyes |
| Week 1 | Comfort - Fanfilcon A Lens (Test) | CUI - very comfortable | 50 Eyes |
| Week 1 | Comfort - Fanfilcon A Lens (Test) | OC - very uncomfortable | 0 Eyes |
| Week 1 | Comfort - Fanfilcon A Lens (Test) | CDD - comfortable | 13 Eyes |
| Week 1 | Comfort - Fanfilcon A Lens (Test) | OC - slightly uncomfortable | 2 Eyes |
| Week 1 | Comfort - Fanfilcon A Lens (Test) | CDD - slightly uncomfortable | 0 Eyes |
| Week 1 | Comfort - Fanfilcon A Lens (Test) | OC - comfortable | 8 Eyes |
| Week 1 | Comfort - Fanfilcon A Lens (Test) | CDD-very uncomfortable | 0 Eyes |
| Week 1 | Comfort - Fanfilcon A Lens (Test) | OC - very comfortable | 58 Eyes |
| Week 1 | Comfort - Fanfilcon A Lens (Test) | EDC - causes pain | 0 Eyes |
| Week 1 | Comfort - Fanfilcon A Lens (Test) | CV - very uncomfortable | 0 Eyes |
| Week 1 | Comfort - Fanfilcon A Lens (Test) | OC - excellent | 40 Eyes |
| Week 1 | Comfort - Fanfilcon A Lens (Test) | EDC - excellent | 32 Eyes |
| Week 2 | Comfort - Fanfilcon A Lens (Test) | CUI - very uncomfortable | 0 Eyes |
| Week 2 | Comfort - Fanfilcon A Lens (Test) | OC - slightly uncomfortable | 0 Eyes |
| Week 2 | Comfort - Fanfilcon A Lens (Test) | EDC - slightly uncomfortable | 2 Eyes |
| Week 2 | Comfort - Fanfilcon A Lens (Test) | CV - comfortable | 11 Eyes |
| Week 2 | Comfort - Fanfilcon A Lens (Test) | OC - excellent | 40 Eyes |
| Week 2 | Comfort - Fanfilcon A Lens (Test) | CDD - slightly uncomfortable | 0 Eyes |
| Week 2 | Comfort - Fanfilcon A Lens (Test) | CUI - excellent | 67 Eyes |
| Week 2 | Comfort - Fanfilcon A Lens (Test) | CV - causes pain | 0 Eyes |
| Week 2 | Comfort - Fanfilcon A Lens (Test) | OC - comfortable | 10 Eyes |
| Week 2 | Comfort - Fanfilcon A Lens (Test) | EDC - very comfortable | 43 Eyes |
| Week 2 | Comfort - Fanfilcon A Lens (Test) | CUI- slightly uncomfortable | 4 Eyes |
| Week 2 | Comfort - Fanfilcon A Lens (Test) | EDC - comfortable | 30 Eyes |
| Week 2 | Comfort - Fanfilcon A Lens (Test) | CDD-very uncomfortable | 2 Eyes |
| Week 2 | Comfort - Fanfilcon A Lens (Test) | CV - very uncomfortable | 2 Eyes |
| Week 2 | Comfort - Fanfilcon A Lens (Test) | CV - slightly uncomfortable | 0 Eyes |
| Week 2 | Comfort - Fanfilcon A Lens (Test) | OC - very comfortable | 54 Eyes |
| Week 2 | Comfort - Fanfilcon A Lens (Test) | OC - causes pain | 0 Eyes |
| Week 2 | Comfort - Fanfilcon A Lens (Test) | EDC - causes pain | 0 Eyes |
| Week 2 | Comfort - Fanfilcon A Lens (Test) | CDD - excellent | 48 Eyes |
| Week 2 | Comfort - Fanfilcon A Lens (Test) | CV - excellent | 63 Eyes |
| Week 2 | Comfort - Fanfilcon A Lens (Test) | CUI - comfortable | 6 Eyes |
| Week 2 | Comfort - Fanfilcon A Lens (Test) | CDD - very comfortable | 47 Eyes |
| Week 2 | Comfort - Fanfilcon A Lens (Test) | EDC - excellent | 31 Eyes |
| Week 2 | Comfort - Fanfilcon A Lens (Test) | CUI - causes pain | 0 Eyes |
| Week 2 | Comfort - Fanfilcon A Lens (Test) | OC - very uncomfortable | 2 Eyes |
| Week 2 | Comfort - Fanfilcon A Lens (Test) | CDD - causes pain | 0 Eyes |
| Week 2 | Comfort - Fanfilcon A Lens (Test) | CV - very comfortable | 30 Eyes |
| Week 2 | Comfort - Fanfilcon A Lens (Test) | EDC - very uncomfortable | 0 Eyes |
| Week 2 | Comfort - Fanfilcon A Lens (Test) | CDD - comfortable | 9 Eyes |
| Week 2 | Comfort - Fanfilcon A Lens (Test) | CUI - very comfortable | 29 Eyes |
| Month 1 | Comfort - Fanfilcon A Lens (Test) | OC - very uncomfortable | 0 Eyes |
| Month 1 | Comfort - Fanfilcon A Lens (Test) | CUI - excellent | 61 Eyes |
| Month 1 | Comfort - Fanfilcon A Lens (Test) | CUI - very comfortable | 36 Eyes |
| Month 1 | Comfort - Fanfilcon A Lens (Test) | CUI - comfortable | 10 Eyes |
| Month 1 | Comfort - Fanfilcon A Lens (Test) | CUI- slightly uncomfortable | 1 Eyes |
| Month 1 | Comfort - Fanfilcon A Lens (Test) | CUI - very uncomfortable | 0 Eyes |
| Month 1 | Comfort - Fanfilcon A Lens (Test) | CUI - causes pain | 0 Eyes |
| Month 1 | Comfort - Fanfilcon A Lens (Test) | CDD - excellent | 50 Eyes |
| Month 1 | Comfort - Fanfilcon A Lens (Test) | CDD - very comfortable | 40 Eyes |
| Month 1 | Comfort - Fanfilcon A Lens (Test) | CDD - comfortable | 9 Eyes |
| Month 1 | Comfort - Fanfilcon A Lens (Test) | CDD - slightly uncomfortable | 9 Eyes |
| Month 1 | Comfort - Fanfilcon A Lens (Test) | CDD-very uncomfortable | 0 Eyes |
| Month 1 | Comfort - Fanfilcon A Lens (Test) | CDD - causes pain | 0 Eyes |
| Month 1 | Comfort - Fanfilcon A Lens (Test) | EDC - excellent | 30 Eyes |
| Month 1 | Comfort - Fanfilcon A Lens (Test) | EDC - very comfortable | 38 Eyes |
| Month 1 | Comfort - Fanfilcon A Lens (Test) | EDC - comfortable | 22 Eyes |
| Month 1 | Comfort - Fanfilcon A Lens (Test) | EDC - slightly uncomfortable | 16 Eyes |
| Month 1 | Comfort - Fanfilcon A Lens (Test) | EDC - very uncomfortable | 2 Eyes |
| Month 1 | Comfort - Fanfilcon A Lens (Test) | EDC - causes pain | 0 Eyes |
| Month 1 | Comfort - Fanfilcon A Lens (Test) | OC - excellent | 43 Eyes |
| Month 1 | Comfort - Fanfilcon A Lens (Test) | OC - very comfortable | 44 Eyes |
| Month 1 | Comfort - Fanfilcon A Lens (Test) | OC - comfortable | 14 Eyes |
| Month 1 | Comfort - Fanfilcon A Lens (Test) | OC - slightly uncomfortable | 7 Eyes |
| Month 1 | Comfort - Fanfilcon A Lens (Test) | OC - causes pain | 0 Eyes |
| Month 1 | Comfort - Fanfilcon A Lens (Test) | CV - excellent | 56 Eyes |
| Month 1 | Comfort - Fanfilcon A Lens (Test) | CV - very comfortable | 38 Eyes |
| Month 1 | Comfort - Fanfilcon A Lens (Test) | CV - comfortable | 6 Eyes |
| Month 1 | Comfort - Fanfilcon A Lens (Test) | CV - slightly uncomfortable | 6 Eyes |
| Month 1 | Comfort - Fanfilcon A Lens (Test) | CV - very uncomfortable | 2 Eyes |
| Month 1 | Comfort - Fanfilcon A Lens (Test) | CV - causes pain | 0 Eyes |
| Month 2 | Comfort - Fanfilcon A Lens (Test) | CUI- slightly uncomfortable | 2 Eyes |
| Month 2 | Comfort - Fanfilcon A Lens (Test) | OC - slightly uncomfortable | 6 Eyes |
| Month 2 | Comfort - Fanfilcon A Lens (Test) | EDC - comfortable | 25 Eyes |
| Month 2 | Comfort - Fanfilcon A Lens (Test) | CV - very comfortable | 36 Eyes |
| Month 2 | Comfort - Fanfilcon A Lens (Test) | CDD - comfortable | 8 Eyes |
| Month 2 | Comfort - Fanfilcon A Lens (Test) | CUI - excellent | 60 Eyes |
| Month 2 | Comfort - Fanfilcon A Lens (Test) | CDD - causes pain | 0 Eyes |
| Month 2 | Comfort - Fanfilcon A Lens (Test) | CDD - very comfortable | 48 Eyes |
| Month 2 | Comfort - Fanfilcon A Lens (Test) | OC - very uncomfortable | 0 Eyes |
| Month 2 | Comfort - Fanfilcon A Lens (Test) | EDC - slightly uncomfortable | 11 Eyes |
| Month 2 | Comfort - Fanfilcon A Lens (Test) | CUI - very uncomfortable | 0 Eyes |
| Month 2 | Comfort - Fanfilcon A Lens (Test) | CV - excellent | 56 Eyes |
| Month 2 | Comfort - Fanfilcon A Lens (Test) | EDC - excellent | 36 Eyes |
| Month 2 | Comfort - Fanfilcon A Lens (Test) | CDD - excellent | 48 Eyes |
| Month 2 | Comfort - Fanfilcon A Lens (Test) | CUI - causes pain | 0 Eyes |
| Month 2 | Comfort - Fanfilcon A Lens (Test) | OC - causes pain | 0 Eyes |
| Month 2 | Comfort - Fanfilcon A Lens (Test) | CV - very uncomfortable | 0 Eyes |
| Month 2 | Comfort - Fanfilcon A Lens (Test) | OC - very comfortable | 42 Eyes |
| Month 2 | Comfort - Fanfilcon A Lens (Test) | EDC - very uncomfortable | 4 Eyes |
| Month 2 | Comfort - Fanfilcon A Lens (Test) | CV - slightly uncomfortable | 4 Eyes |
| Month 2 | Comfort - Fanfilcon A Lens (Test) | CDD-very uncomfortable | 0 Eyes |
| Month 2 | Comfort - Fanfilcon A Lens (Test) | CV - causes pain | 0 Eyes |
| Month 2 | Comfort - Fanfilcon A Lens (Test) | EDC - causes pain | 0 Eyes |
| Month 2 | Comfort - Fanfilcon A Lens (Test) | CUI - very comfortable | 40 Eyes |
| Month 2 | Comfort - Fanfilcon A Lens (Test) | OC - comfortable | 14 Eyes |
| Month 2 | Comfort - Fanfilcon A Lens (Test) | OC - excellent | 46 Eyes |
| Month 2 | Comfort - Fanfilcon A Lens (Test) | CUI - comfortable | 6 Eyes |
| Month 2 | Comfort - Fanfilcon A Lens (Test) | CDD - slightly uncomfortable | 4 Eyes |
| Month 2 | Comfort - Fanfilcon A Lens (Test) | CV - comfortable | 12 Eyes |
| Month 2 | Comfort - Fanfilcon A Lens (Test) | EDC - very comfortable | 32 Eyes |
| Month 3 | Comfort - Fanfilcon A Lens (Test) | CV - comfortable | 8 Eyes |
| Month 3 | Comfort - Fanfilcon A Lens (Test) | EDC - excellent | 30 Eyes |
| Month 3 | Comfort - Fanfilcon A Lens (Test) | EDC - causes pain | 0 Eyes |
| Month 3 | Comfort - Fanfilcon A Lens (Test) | CDD - causes pain | 0 Eyes |
| Month 3 | Comfort - Fanfilcon A Lens (Test) | CV - causes pain | 0 Eyes |
| Month 3 | Comfort - Fanfilcon A Lens (Test) | OC - excellent | 46 Eyes |
| Month 3 | Comfort - Fanfilcon A Lens (Test) | CDD-very uncomfortable | 0 Eyes |
| Month 3 | Comfort - Fanfilcon A Lens (Test) | OC - very comfortable | 48 Eyes |
| Month 3 | Comfort - Fanfilcon A Lens (Test) | CDD - slightly uncomfortable | 4 Eyes |
| Month 3 | Comfort - Fanfilcon A Lens (Test) | CV - very uncomfortable | 0 Eyes |
| Month 3 | Comfort - Fanfilcon A Lens (Test) | OC - comfortable | 8 Eyes |
| Month 3 | Comfort - Fanfilcon A Lens (Test) | CDD - comfortable | 6 Eyes |
| Month 3 | Comfort - Fanfilcon A Lens (Test) | OC - slightly uncomfortable | 6 Eyes |
| Month 3 | Comfort - Fanfilcon A Lens (Test) | CDD - very comfortable | 50 Eyes |
| Month 3 | Comfort - Fanfilcon A Lens (Test) | OC - very uncomfortable | 0 Eyes |
| Month 3 | Comfort - Fanfilcon A Lens (Test) | CDD - excellent | 48 Eyes |
| Month 3 | Comfort - Fanfilcon A Lens (Test) | OC - causes pain | 0 Eyes |
| Month 3 | Comfort - Fanfilcon A Lens (Test) | CUI - causes pain | 0 Eyes |
| Month 3 | Comfort - Fanfilcon A Lens (Test) | CUI - excellent | 64 Eyes |
| Month 3 | Comfort - Fanfilcon A Lens (Test) | CV - excellent | 62 Eyes |
| Month 3 | Comfort - Fanfilcon A Lens (Test) | CUI - very uncomfortable | 0 Eyes |
| Month 3 | Comfort - Fanfilcon A Lens (Test) | CV - very comfortable | 34 Eyes |
| Month 3 | Comfort - Fanfilcon A Lens (Test) | CUI- slightly uncomfortable | 2 Eyes |
| Month 3 | Comfort - Fanfilcon A Lens (Test) | CUI - comfortable | 2 Eyes |
| Month 3 | Comfort - Fanfilcon A Lens (Test) | CV - slightly uncomfortable | 4 Eyes |
| Month 3 | Comfort - Fanfilcon A Lens (Test) | EDC - comfortable | 24 Eyes |
| Month 3 | Comfort - Fanfilcon A Lens (Test) | EDC - slightly uncomfortable | 8 Eyes |
| Month 3 | Comfort - Fanfilcon A Lens (Test) | EDC - very comfortable | 44 Eyes |
| Month 3 | Comfort - Fanfilcon A Lens (Test) | CUI - very comfortable | 40 Eyes |
| Month 3 | Comfort - Fanfilcon A Lens (Test) | EDC - very uncomfortable | 2 Eyes |
| Unscheduled | Comfort - Fanfilcon A Lens (Test) | EDC - slightly uncomfortable | 0 Eyes |
| Unscheduled | Comfort - Fanfilcon A Lens (Test) | CV - very comfortable | 2 Eyes |
| Unscheduled | Comfort - Fanfilcon A Lens (Test) | CUI- slightly uncomfortable | 0 Eyes |
| Unscheduled | Comfort - Fanfilcon A Lens (Test) | OC - excellent | 2 Eyes |
| Unscheduled | Comfort - Fanfilcon A Lens (Test) | CV - very uncomfortable | 0 Eyes |
| Unscheduled | Comfort - Fanfilcon A Lens (Test) | CV - causes pain | 0 Eyes |
| Unscheduled | Comfort - Fanfilcon A Lens (Test) | CDD - comfortable | 0 Eyes |
| Unscheduled | Comfort - Fanfilcon A Lens (Test) | EDC - excellent | 2 Eyes |
| Unscheduled | Comfort - Fanfilcon A Lens (Test) | CV - comfortable | 0 Eyes |
| Unscheduled | Comfort - Fanfilcon A Lens (Test) | CUI - comfortable | 0 Eyes |
| Unscheduled | Comfort - Fanfilcon A Lens (Test) | EDC - very comfortable | 2 Eyes |
| Unscheduled | Comfort - Fanfilcon A Lens (Test) | OC - comfortable | 0 Eyes |
| Unscheduled | Comfort - Fanfilcon A Lens (Test) | CDD - slightly uncomfortable | 0 Eyes |
| Unscheduled | Comfort - Fanfilcon A Lens (Test) | OC - very comfortable | 2 Eyes |
| Unscheduled | Comfort - Fanfilcon A Lens (Test) | EDC - causes pain | 0 Eyes |
| Unscheduled | Comfort - Fanfilcon A Lens (Test) | CV - slightly uncomfortable | 0 Eyes |
| Unscheduled | Comfort - Fanfilcon A Lens (Test) | EDC - comfortable | 0 Eyes |
| Unscheduled | Comfort - Fanfilcon A Lens (Test) | OC - causes pain | 0 Eyes |
| Unscheduled | Comfort - Fanfilcon A Lens (Test) | CUI - causes pain | 0 Eyes |
| Unscheduled | Comfort - Fanfilcon A Lens (Test) | EDC - very uncomfortable | 0 Eyes |
| Unscheduled | Comfort - Fanfilcon A Lens (Test) | CUI - excellent | 4 Eyes |
| Unscheduled | Comfort - Fanfilcon A Lens (Test) | CUI - very comfortable | 0 Eyes |
| Unscheduled | Comfort - Fanfilcon A Lens (Test) | CDD - excellent | 2 Eyes |
| Unscheduled | Comfort - Fanfilcon A Lens (Test) | CDD-very uncomfortable | 0 Eyes |
| Unscheduled | Comfort - Fanfilcon A Lens (Test) | CV - excellent | 2 Eyes |
| Unscheduled | Comfort - Fanfilcon A Lens (Test) | CUI - very uncomfortable | 0 Eyes |
| Unscheduled | Comfort - Fanfilcon A Lens (Test) | CDD - causes pain | 0 Eyes |
| Unscheduled | Comfort - Fanfilcon A Lens (Test) | OC - very uncomfortable | 0 Eyes |
| Unscheduled | Comfort - Fanfilcon A Lens (Test) | CDD - very comfortable | 2 Eyes |
| Unscheduled | Comfort - Fanfilcon A Lens (Test) | OC - slightly uncomfortable | 0 Eyes |
Ease of Insertion and Removal - Enfilcon A Lens (Control)
Ease of Insertion (EOI) and removal (EOR) was assessed. Subjects were asked to rate ease of insertion and removal on scale 0-5 (0=excellent, 1=very good, 2=good, 3=poor, 4=very poor, or 5=unmanageable.
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Population: All sites, control completed subjects' eyes. Three subjects data was not collected during Week 1 visit. One subject data was not collected during Month 2 visit.~Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Baseline | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - very good | 12 Eyes |
| Baseline | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - unmanageable | 0 Eyes |
| Baseline | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - good | 6 Eyes |
| Baseline | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - good | 10 Eyes |
| Baseline | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - very good | 12 Eyes |
| Baseline | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - unmanageable | 0 Eyes |
| Baseline | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - excellent | 40 Eyes |
| Baseline | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - excellent | 34 Eyes |
| Baseline | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - poor | 0 Eyes |
| Baseline | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - very poor | 0 Eyes |
| Baseline | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - poor | 2 Eyes |
| Baseline | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - very poor | 0 Eyes |
| Week 1 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - poor | 2 Eyes |
| Week 1 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - unmanageable | 0 Eyes |
| Week 1 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - unmanageable | 1 Eyes |
| Week 1 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - very poor | 0 Eyes |
| Week 1 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - very good | 14 Eyes |
| Week 1 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - very good | 12 Eyes |
| Week 1 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - excellent | 31 Eyes |
| Week 1 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - excellent | 36 Eyes |
| Week 1 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - good | 5 Eyes |
| Week 1 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - very poor | 0 Eyes |
| Week 1 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - poor | 1 Eyes |
| Week 1 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - good | 2 Eyes |
| Week 2 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - good | 5 Eyes |
| Week 2 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - poor | 1 Eyes |
| Week 2 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - very good | 12 Eyes |
| Week 2 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - good | 10 Eyes |
| Week 2 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - excellent | 36 Eyes |
| Week 2 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - unmanageable | 0 Eyes |
| Week 2 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - poor | 0 Eyes |
| Week 2 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - very poor | 0 Eyes |
| Week 2 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - unmanageable | 0 Eyes |
| Week 2 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - excellent | 40 Eyes |
| Week 2 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - very good | 12 Eyes |
| Week 2 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - very poor | 0 Eyes |
| Month 1 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - good | 8 Eyes |
| Month 1 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - very poor | 0 Eyes |
| Month 1 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - unmanageable | 0 Eyes |
| Month 1 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - very good | 16 Eyes |
| Month 1 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - good | 10 Eyes |
| Month 1 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - very good | 16 Eyes |
| Month 1 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - unmanageable | 0 Eyes |
| Month 1 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - poor | 0 Eyes |
| Month 1 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - very poor | 0 Eyes |
| Month 1 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - excellent | 34 Eyes |
| Month 1 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - poor | 2 Eyes |
| Month 1 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - excellent | 30 Eyes |
| Month 2 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - unmanageable | 0 Eyes |
| Month 2 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - unmanageable | 0 Eyes |
| Month 2 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - good | 6 Eyes |
| Month 2 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - very poor | 0 Eyes |
| Month 2 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - excellent | 36 Eyes |
| Month 2 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - poor | 4 Eyes |
| Month 2 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - very good | 10 Eyes |
| Month 2 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - good | 4 Eyes |
| Month 2 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - very good | 16 Eyes |
| Month 2 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - poor | 0 Eyes |
| Month 2 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - very poor | 0 Eyes |
| Month 2 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - excellent | 36 Eyes |
| Month 3 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - unmanageable | 0 Eyes |
| Month 3 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - excellent | 30 Eyes |
| Month 3 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - very good | 17 Eyes |
| Month 3 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - good | 7 Eyes |
| Month 3 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - poor | 4 Eyes |
| Month 3 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - very poor | 0 Eyes |
| Month 3 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - unmanageable | 0 Eyes |
| Month 3 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - excellent | 34 Eyes |
| Month 3 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - very good | 14 Eyes |
| Month 3 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - good | 10 Eyes |
| Month 3 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - poor | 0 Eyes |
| Month 3 | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - very poor | 0 Eyes |
| Unscheduled | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - good | 0 Eyes |
| Unscheduled | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - very good | 0 Eyes |
| Unscheduled | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - excellent | 6 Eyes |
| Unscheduled | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - unmanageable | 0 Eyes |
| Unscheduled | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - unmanageable | 0 Eyes |
| Unscheduled | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - very poor | 0 Eyes |
| Unscheduled | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - very poor | 0 Eyes |
| Unscheduled | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - poor | 0 Eyes |
| Unscheduled | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - good | 0 Eyes |
| Unscheduled | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - very good | 0 Eyes |
| Unscheduled | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOI - excellent | 6 Eyes |
| Unscheduled | Ease of Insertion and Removal - Enfilcon A Lens (Control) | EOR - poor | 0 Eyes |
Ease of Insertion and Removal - Fanfilcon A Lens (Test)
Ease of Insertion (EOI) and removal (EOR) was assessed. Subjects were asked to rate ease of insertion and removal on scale 0-5 (0=excellent, 1=very good, 2=good, 3=poor, 4=very poor, or 5=unmanageable.
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Population: All sites, test subjects' completed eyes. One subject data was not collected at 2 week visit.~Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Baseline | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - unmanageable | 0 eyes |
| Baseline | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - unmanageable | 0 eyes |
| Baseline | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - very good | 28 eyes |
| Baseline | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - excellent | 72 eyes |
| Baseline | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - very good | 26 eyes |
| Baseline | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - excellent | 78 eyes |
| Baseline | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - good | 4 eyes |
| Baseline | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - very poor | 0 eyes |
| Baseline | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - poor | 0 eyes |
| Baseline | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - poor | 0 eyes |
| Baseline | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - very poor | 0 eyes |
| Baseline | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - good | 8 eyes |
| Week 1 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - excellent | 70 eyes |
| Week 1 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - unmanageable | 0 eyes |
| Week 1 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - good | 4 eyes |
| Week 1 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - poor | 4 eyes |
| Week 1 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - unmanageable | 0 eyes |
| Week 1 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - excellent | 62 eyes |
| Week 1 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - good | 11 eyes |
| Week 1 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - very good | 31 eyes |
| Week 1 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - very good | 34 eyes |
| Week 1 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - poor | 0 eyes |
| Week 1 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - very poor | 0 eyes |
| Week 1 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - very poor | 0 eyes |
| Week 2 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - unmanageable | 0 eyes |
| Week 2 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - very poor | 2 eyes |
| Week 2 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - good | 2 eyes |
| Week 2 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - poor | 2 eyes |
| Week 2 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - poor | 0 eyes |
| Week 2 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - very poor | 2 eyes |
| Week 2 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - unmanageable | 0 eyes |
| Week 2 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - very good | 33 eyes |
| Week 2 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - good | 12 eyes |
| Week 2 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - excellent | 57 eyes |
| Week 2 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - very good | 30 eyes |
| Week 2 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - excellent | 72 eyes |
| Month 1 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - very poor | 0 eyes |
| Month 1 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - excellent | 73 eyes |
| Month 1 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - very good | 30 eyes |
| Month 1 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - good | 2 eyes |
| Month 1 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - poor | 3 eyes |
| Month 1 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - very poor | 0 eyes |
| Month 1 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - unmanageable | 0 eyes |
| Month 1 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - excellent | 48 eyes |
| Month 1 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - very good | 43 eyes |
| Month 1 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - good | 15 eyes |
| Month 1 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - poor | 2 eyes |
| Month 1 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - unmanageable | 0 eyes |
| Month 2 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - good | 18 eyes |
| Month 2 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - excellent | 68 eyes |
| Month 2 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - good | 6 eyes |
| Month 2 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - poor | 0 eyes |
| Month 2 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - poor | 2 eyes |
| Month 2 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - very good | 30 eyes |
| Month 2 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - excellent | 58 eyes |
| Month 2 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - very poor | 0 eyes |
| Month 2 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - very poor | 0 eyes |
| Month 2 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - very good | 34 eyes |
| Month 2 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - unmanageable | 0 eyes |
| Month 2 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - unmanageable | 0 eyes |
| Month 3 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - excellent | 56 eyes |
| Month 3 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - very poor | 0 eyes |
| Month 3 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - very good | 30 eyes |
| Month 3 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - poor | 0 eyes |
| Month 3 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - good | 22 eyes |
| Month 3 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - good | 4 eyes |
| Month 3 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - unmanageable | 0 eyes |
| Month 3 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - poor | 0 eyes |
| Month 3 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - very good | 32 eyes |
| Month 3 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - very poor | 0 eyes |
| Month 3 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - excellent | 72 eyes |
| Month 3 | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - unmanageable | 0 eyes |
| Unscheduled | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - excellent | 2 eyes |
| Unscheduled | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - poor | 0 eyes |
| Unscheduled | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - very good | 2 eyes |
| Unscheduled | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - unmanageable | 0 eyes |
| Unscheduled | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - very poor | 0 eyes |
| Unscheduled | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - excellent | 2 eyes |
| Unscheduled | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - very poor | 0 eyes |
| Unscheduled | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - good | 0 eyes |
| Unscheduled | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - unmanageable | 0 eyes |
| Unscheduled | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - poor | 0 eyes |
| Unscheduled | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOR - good | 0 eyes |
| Unscheduled | Ease of Insertion and Removal - Fanfilcon A Lens (Test) | EOI - very good | 2 eyes |
Overall Vision Quality - Enfilcon A Lens (Control)
Overall vision quality (OVQ) and vision at night (VAN) is assessed at the specific time points. Subjects were asked to rate vision from 0-5, (0=excellent, 1=very good, 2=good, 3=poor, 4=very poor, 5= unacceptable).
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Population: All sites, control completed subjects. Three subjects data was not collected during Week 1 visit. One subject data was not collected during Month 2 visit.~Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Baseline | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - unacceptable | 0 eyes |
| Baseline | Overall Vision Quality - Enfilcon A Lens (Control) | VAN- unacceptable | 0 eyes |
| Baseline | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - very good | 26 eyes |
| Baseline | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - excellent | 13 eyes |
| Baseline | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - very good | 24 eyes |
| Baseline | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - excellent | 23 eyes |
| Baseline | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - good | 11 eyes |
| Baseline | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - very poor | 0 eyes |
| Baseline | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - poor | 0 eyes |
| Baseline | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - poor | 0 eyes |
| Baseline | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - very poor | 0 eyes |
| Baseline | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - good | 19 eyes |
| Week 1 | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - excellent | 28 eyes |
| Week 1 | Overall Vision Quality - Enfilcon A Lens (Control) | VAN- unacceptable | 0 eyes |
| Week 1 | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - good | 12 eyes |
| Week 1 | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - poor | 2 eyes |
| Week 1 | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - unacceptable | 0 eyes |
| Week 1 | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - excellent | 26 eyes |
| Week 1 | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - good | 12 eyes |
| Week 1 | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - very good | 12 eyes |
| Week 1 | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - very good | 10 eyes |
| Week 1 | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - poor | 2 eyes |
| Week 1 | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - very poor | 0 eyes |
| Week 1 | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - very poor | 0 eyes |
| Week 2 | Overall Vision Quality - Enfilcon A Lens (Control) | VAN- unacceptable | 0 eyes |
| Week 2 | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - very poor | 0 eyes |
| Week 2 | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - good | 12 eyes |
| Week 2 | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - poor | 1 eyes |
| Week 2 | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - poor | 1 eyes |
| Week 2 | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - very poor | 0 eyes |
| Week 2 | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - unacceptable | 0 eyes |
| Week 2 | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - very good | 15 eyes |
| Week 2 | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - good | 14 eyes |
| Week 2 | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - excellent | 28 eyes |
| Week 2 | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - very good | 17 eyes |
| Week 2 | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - excellent | 28 eyes |
| Month 1 | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - very poor | 0 eyes |
| Month 1 | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - excellent | 22 eyes |
| Month 1 | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - very good | 20 eyes |
| Month 1 | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - good | 14 eyes |
| Month 1 | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - poor | 2 eyes |
| Month 1 | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - very poor | 0 eyes |
| Month 1 | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - unacceptable | 0 eyes |
| Month 1 | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - excellent | 22 eyes |
| Month 1 | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - very good | 18 eyes |
| Month 1 | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - good | 14 eyes |
| Month 1 | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - poor | 4 eyes |
| Month 1 | Overall Vision Quality - Enfilcon A Lens (Control) | VAN- unacceptable | 0 eyes |
| Month 2 | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - good | 11 eyes |
| Month 2 | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - excellent | 30 eyes |
| Month 2 | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - good | 9 eyes |
| Month 2 | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - poor | 0 eyes |
| Month 2 | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - poor | 2 eyes |
| Month 2 | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - very good | 21 eyes |
| Month 2 | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - excellent | 20 eyes |
| Month 2 | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - very poor | 2 eyes |
| Month 2 | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - very poor | 2 eyes |
| Month 2 | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - very good | 15 eyes |
| Month 2 | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - unacceptable | 0 eyes |
| Month 2 | Overall Vision Quality - Enfilcon A Lens (Control) | VAN- unacceptable | 0 eyes |
| Month 3 | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - excellent | 20 eyes |
| Month 3 | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - very poor | 1 eyes |
| Month 3 | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - very good | 16 eyes |
| Month 3 | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - poor | 4 eyes |
| Month 3 | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - good | 18 eyes |
| Month 3 | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - good | 12 eyes |
| Month 3 | Overall Vision Quality - Enfilcon A Lens (Control) | VAN- unacceptable | 0 eyes |
| Month 3 | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - poor | 4 eyes |
| Month 3 | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - very good | 16 eyes |
| Month 3 | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - very poor | 0 eyes |
| Month 3 | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - excellent | 25 eyes |
| Month 3 | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - unacceptable | 0 eyes |
| Unscheduled | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - excellent | 4 eyes |
| Unscheduled | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - poor | 0 eyes |
| Unscheduled | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - very good | 2 eyes |
| Unscheduled | Overall Vision Quality - Enfilcon A Lens (Control) | VAN- unacceptable | 0 eyes |
| Unscheduled | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - very poor | 0 eyes |
| Unscheduled | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - excellent | 4 eyes |
| Unscheduled | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - very poor | 0 eyes |
| Unscheduled | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - good | 2 eyes |
| Unscheduled | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - unacceptable | 0 eyes |
| Unscheduled | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - poor | 0 eyes |
| Unscheduled | Overall Vision Quality - Enfilcon A Lens (Control) | VAN - good | 0 eyes |
| Unscheduled | Overall Vision Quality - Enfilcon A Lens (Control) | OVC - very good | 0 eyes |
Overall Vision Quality - Fanfilcon A Lens (Test)
Overall vision quality (OVQ) and vision at night (VAN) is assessed at the specific time points. Subjects were asked to rate vision from 0-5, (0=excellent, 1=very good, 2=good, 3=poor, 4=very poor, 5= unacceptable).
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Population: All sites, test subjects' completed. One subject data was not collected at 2 week visit.~Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Baseline | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - unacceptable | 0 eyes |
| Baseline | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - unacceptable | 2 eyes |
| Baseline | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - very good | 33 eyes |
| Baseline | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - excellent | 41 eyes |
| Baseline | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - very good | 41 eyes |
| Baseline | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - excellent | 53 eyes |
| Baseline | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - good | 8 eyes |
| Baseline | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - very poor | 0 eyes |
| Baseline | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - poor | 6 eyes |
| Baseline | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - poor | 4 eyes |
| Baseline | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - very poor | 0 eyes |
| Baseline | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - good | 28 eyes |
| Week 1 | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - excellent | 70 eyes |
| Week 1 | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - unacceptable | 0 eyes |
| Week 1 | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - good | 8 eyes |
| Week 1 | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - poor | 0 eyes |
| Week 1 | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - unacceptable | 0 eyes |
| Week 1 | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - excellent | 60 eyes |
| Week 1 | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - good | 14 eyes |
| Week 1 | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - very good | 34 eyes |
| Week 1 | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - very good | 30 eyes |
| Week 1 | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - poor | 0 eyes |
| Week 1 | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - very poor | 0 eyes |
| Week 1 | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - very poor | 0 eyes |
| Week 2 | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - unacceptable | 0 eyes |
| Week 2 | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - very poor | 2 eyes |
| Week 2 | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - good | 9 eyes |
| Week 2 | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - poor | 2 eyes |
| Week 2 | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - poor | 0 eyes |
| Week 2 | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - very poor | 0 eyes |
| Week 2 | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - unacceptable | 0 eyes |
| Week 2 | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - very good | 32 eyes |
| Week 2 | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - good | 14 eyes |
| Week 2 | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - excellent | 58 eyes |
| Week 2 | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - very good | 27 eyes |
| Week 2 | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - excellent | 68 eyes |
| Month 1 | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - very poor | 0 eyes |
| Month 1 | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - excellent | 64 eyes |
| Month 1 | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - very good | 28 eyes |
| Month 1 | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - good | 16 eyes |
| Month 1 | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - poor | 0 eyes |
| Month 1 | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - very poor | 0 eyes |
| Month 1 | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - unacceptable | 0 eyes |
| Month 1 | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - excellent | 50 eyes |
| Month 1 | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - very good | 32 eyes |
| Month 1 | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - good | 26 eyes |
| Month 1 | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - poor | 0 eyes |
| Month 1 | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - unacceptable | 0 eyes |
| Month 2 | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - good | 22 eyes |
| Month 2 | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - excellent | 64 eyes |
| Month 2 | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - good | 11 eyes |
| Month 2 | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - poor | 2 eyes |
| Month 2 | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - poor | 0 eyes |
| Month 2 | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - very good | 34 eyes |
| Month 2 | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - excellent | 52 eyes |
| Month 2 | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - very poor | 0 eyes |
| Month 2 | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - very poor | 0 eyes |
| Month 2 | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - very good | 30 eyes |
| Month 2 | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - unacceptable | 1 eyes |
| Month 2 | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - unacceptable | 0 eyes |
| Month 3 | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - excellent | 60 eyes |
| Month 3 | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - very poor | 0 eyes |
| Month 3 | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - very good | 32 eyes |
| Month 3 | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - poor | 2 eyes |
| Month 3 | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - good | 12 eyes |
| Month 3 | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - good | 4 eyes |
| Month 3 | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - unacceptable | 0 eyes |
| Month 3 | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - poor | 4 eyes |
| Month 3 | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - very good | 32 eyes |
| Month 3 | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - very poor | 0 eyes |
| Month 3 | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - excellent | 70 eyes |
| Month 3 | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - unacceptable | 0 eyes |
| Unscheduled | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - excellent | 4 eyes |
| Unscheduled | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - poor | 0 eyes |
| Unscheduled | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - very good | 0 eyes |
| Unscheduled | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - unacceptable | 0 eyes |
| Unscheduled | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - very poor | 0 eyes |
| Unscheduled | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - excellent | 4 eyes |
| Unscheduled | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - very poor | 0 eyes |
| Unscheduled | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - good | 0 eyes |
| Unscheduled | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - unacceptable | 0 eyes |
| Unscheduled | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - poor | 0 eyes |
| Unscheduled | Overall Vision Quality - Fanfilcon A Lens (Test) | VAN - good | 0 eyes |
| Unscheduled | Overall Vision Quality - Fanfilcon A Lens (Test) | OVC - very good | 0 eyes |