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Evaluation of the CooperVision, Inc. Fanfilcon A and Enfilcon A Daily Wear Contact Lenses When Used for Frequent Replacement for up to One (1) Month of Daily Wear

Evaluation of the CooperVision, Inc. Fanfilcon A and Enfilcon A Daily Wear Contact Lenses When Used for Frequent Replacement for up to One (1) Month of Daily Wear

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02555722
Enrollment
92
Registered
2015-09-21
Start date
2015-09-21
Completion date
2016-05-31
Last updated
2019-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

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

DEVICEenfilcon A (control)

silicone hydrogel lens

Sponsors

CooperVision, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Average Wearing Time - Enfilcon A Lens (Control)Baseline, Week 1, Week 2, Month 1, Month 2, Month 3Average 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 3Bulbar 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 3Palpebral 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 3Palpebral 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 3Visual 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 3Visual 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 3Average 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 3Bulbar 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 3Epithelial 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 3Epithelial 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 3Stromal 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 3Stromal 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 3Corneal 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 3Corneal 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 3Corneal 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 3Corneal 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 3Corneal 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 3Corneal 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 3Limbal 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 3Limbal hyperemia is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe

Secondary

MeasureTime frameDescription
Comfort - Enfilcon A Lens (Control)Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months follow-upEnfilcon 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 3Overall 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 3Overall 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 3Ease 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 3Ease 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 3Fanfilcon 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

ArmCount
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
Total90

Withdrawals & dropouts

PeriodReasonFG000FG001
Month 1Lens Discomfort10
Month 2Lost to Follow-up10
Month 2Withdrawal by Subject30
Week 2Adverse Event01
Week 2Withdrawal by Subject10

Baseline characteristics

CharacteristicFanfilcon A (Test)Enfilcon A (Control)Total
Age, Continuous34.72 years
STANDARD_DEVIATION 10.32
33.67 years
STANDARD_DEVIATION 10.162
34.37 years
STANDARD_DEVIATION 10.223
Sex: Female, Male
Female
49 Participants23 Participants72 Participants
Sex: Female, Male
Male
11 Participants7 Participants18 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 600 / 30
other
Total, other adverse events
0 / 600 / 30
serious
Total, serious adverse events
0 / 600 / 30

Outcome results

Primary

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.

ArmMeasureValue (MEAN)Dispersion
BaselineAverage Wearing Time - Enfilcon A Lens (Control)13.81 hoursStandard Deviation 2.95
Week 1Average Wearing Time - Enfilcon A Lens (Control)13.67 hoursStandard Deviation 2.58
Week 2Average Wearing Time - Enfilcon A Lens (Control)13.41 hoursStandard Deviation 2.28
Month 1Average Wearing Time - Enfilcon A Lens (Control)13.52 hoursStandard Deviation 2.11
Month 2Average Wearing Time - Enfilcon A Lens (Control)13.20 hoursStandard Deviation 2.5
Month 3Average Wearing Time - Enfilcon A Lens (Control)13.62 hoursStandard Deviation 2.35
UnscheduledAverage Wearing Time - Enfilcon A Lens (Control)12.67 hoursStandard Deviation 1.16
Primary

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.

ArmMeasureValue (MEAN)Dispersion
BaselineAverage Wearing Time - Fanfilcon A Lens (Test)14.17 hoursStandard Deviation 4.24
Week 1Average Wearing Time - Fanfilcon A Lens (Test)13.25 hoursStandard Deviation 2.56
Week 2Average Wearing Time - Fanfilcon A Lens (Test)13.08 hoursStandard Deviation 2.23
Month 1Average Wearing Time - Fanfilcon A Lens (Test)13.18 hoursStandard Deviation 2.59
Month 2Average Wearing Time - Fanfilcon A Lens (Test)13.21 hoursStandard Deviation 2.41
Month 3Average Wearing Time - Fanfilcon A Lens (Test)13.13 hoursStandard Deviation 2.61
UnscheduledAverage Wearing Time - Fanfilcon A Lens (Test)16.50 hoursStandard Deviation 0.71
Primary

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.

ArmMeasureGroupValue (NUMBER)
BaselineBulbar Hyperemia - Enfilcon A Lens (Control)None65.5 percentage of eyes
BaselineBulbar Hyperemia - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
BaselineBulbar Hyperemia - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
BaselineBulbar Hyperemia - Enfilcon A Lens (Control)Mild0.0 percentage of eyes
BaselineBulbar Hyperemia - Enfilcon A Lens (Control)Trace34.5 percentage of eyes
Week 1Bulbar Hyperemia - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
Week 1Bulbar Hyperemia - Enfilcon A Lens (Control)None61.5 percentage of eyes
Week 1Bulbar Hyperemia - Enfilcon A Lens (Control)Trace38.5 percentage of eyes
Week 1Bulbar Hyperemia - Enfilcon A Lens (Control)Mild0.0 percentage of eyes
Week 1Bulbar Hyperemia - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
Week 2Bulbar Hyperemia - Enfilcon A Lens (Control)Trace27.6 percentage of eyes
Week 2Bulbar Hyperemia - Enfilcon A Lens (Control)None72.4 percentage of eyes
Week 2Bulbar Hyperemia - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
Week 2Bulbar Hyperemia - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
Week 2Bulbar Hyperemia - Enfilcon A Lens (Control)Mild0.0 percentage of eyes
Month 1Bulbar Hyperemia - Enfilcon A Lens (Control)None69.0 percentage of eyes
Month 1Bulbar Hyperemia - Enfilcon A Lens (Control)Trace31.0 percentage of eyes
Month 1Bulbar Hyperemia - Enfilcon A Lens (Control)Mild0.0 percentage of eyes
Month 1Bulbar Hyperemia - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
Month 1Bulbar Hyperemia - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
Month 2Bulbar Hyperemia - Enfilcon A Lens (Control)Trace7.1 percentage of eyes
Month 2Bulbar Hyperemia - Enfilcon A Lens (Control)None92.9 percentage of eyes
Month 2Bulbar Hyperemia - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
Month 2Bulbar Hyperemia - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
Month 2Bulbar Hyperemia - Enfilcon A Lens (Control)Mild0.0 percentage of eyes
Month 3Bulbar Hyperemia - Enfilcon A Lens (Control)None81.0 percentage of eyes
Month 3Bulbar Hyperemia - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
Month 3Bulbar Hyperemia - Enfilcon A Lens (Control)Mild1.7 percentage of eyes
Month 3Bulbar Hyperemia - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
Month 3Bulbar Hyperemia - Enfilcon A Lens (Control)Trace17.2 percentage of eyes
UnscheduledBulbar Hyperemia - Enfilcon A Lens (Control)Mild0.0 percentage of eyes
UnscheduledBulbar Hyperemia - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
UnscheduledBulbar Hyperemia - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
UnscheduledBulbar Hyperemia - Enfilcon A Lens (Control)Trace0.0 percentage of eyes
UnscheduledBulbar Hyperemia - Enfilcon A Lens (Control)None100.0 percentage of eyes
Primary

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.

ArmMeasureGroupValue (NUMBER)
BaselineBulbar Hyperemia - Fanfilcon A Lens (Test)Mild0.0 percentage of eyes
BaselineBulbar Hyperemia - Fanfilcon A Lens (Test)None60.2 percentage of eyes
BaselineBulbar Hyperemia - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
BaselineBulbar Hyperemia - Fanfilcon A Lens (Test)Trace39.8 percentage of eyes
BaselineBulbar Hyperemia - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
Week 1Bulbar Hyperemia - Fanfilcon A Lens (Test)Mild0.9 percentage of eyes
Week 1Bulbar Hyperemia - Fanfilcon A Lens (Test)Trace21.3 percentage of eyes
Week 1Bulbar Hyperemia - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
Week 1Bulbar Hyperemia - Fanfilcon A Lens (Test)None77.8 percentage of eyes
Week 1Bulbar Hyperemia - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
Week 2Bulbar Hyperemia - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
Week 2Bulbar Hyperemia - Fanfilcon A Lens (Test)Trace32.1 percentage of eyes
Week 2Bulbar Hyperemia - Fanfilcon A Lens (Test)None67.0 percentage of eyes
Week 2Bulbar Hyperemia - Fanfilcon A Lens (Test)Mild0.9 percentage of eyes
Week 2Bulbar Hyperemia - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
Month 1Bulbar Hyperemia - Fanfilcon A Lens (Test)Mild0.0 percentage of eyes
Month 1Bulbar Hyperemia - Fanfilcon A Lens (Test)None68.5 percentage of eyes
Month 1Bulbar Hyperemia - Fanfilcon A Lens (Test)Trace31.5 percentage of eyes
Month 1Bulbar Hyperemia - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
Month 1Bulbar Hyperemia - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
Month 2Bulbar Hyperemia - Fanfilcon A Lens (Test)None73.1 percentage of eyes
Month 2Bulbar Hyperemia - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
Month 2Bulbar Hyperemia - Fanfilcon A Lens (Test)Mild0.0 percentage of eyes
Month 2Bulbar Hyperemia - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
Month 2Bulbar Hyperemia - Fanfilcon A Lens (Test)Trace26.9 percentage of eyes
Month 3Bulbar Hyperemia - Fanfilcon A Lens (Test)None69.4 percentage of eyes
Month 3Bulbar Hyperemia - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
Month 3Bulbar Hyperemia - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
Month 3Bulbar Hyperemia - Fanfilcon A Lens (Test)Trace29.6 percentage of eyes
Month 3Bulbar Hyperemia - Fanfilcon A Lens (Test)Mild0.9 percentage of eyes
UnscheduledBulbar Hyperemia - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
UnscheduledBulbar Hyperemia - Fanfilcon A Lens (Test)Trace33.3 percentage of eyes
UnscheduledBulbar Hyperemia - Fanfilcon A Lens (Test)Mild0.0 percentage of eyes
UnscheduledBulbar Hyperemia - Fanfilcon A Lens (Test)None66.7 percentage of eyes
UnscheduledBulbar Hyperemia - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
Primary

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.

ArmMeasureGroupValue (NUMBER)
BaselineCorneal Infiltrates - Enfilcon A Lens (Control)Absent100.0 percentage of eyes
BaselineCorneal Infiltrates - Enfilcon A Lens (Control)Present0.0 percentage of eyes
Week 1Corneal Infiltrates - Enfilcon A Lens (Control)Absent100.0 percentage of eyes
Week 1Corneal Infiltrates - Enfilcon A Lens (Control)Present0.0 percentage of eyes
Week 2Corneal Infiltrates - Enfilcon A Lens (Control)Absent100.0 percentage of eyes
Week 2Corneal Infiltrates - Enfilcon A Lens (Control)Present0.0 percentage of eyes
Month 1Corneal Infiltrates - Enfilcon A Lens (Control)Absent100.0 percentage of eyes
Month 1Corneal Infiltrates - Enfilcon A Lens (Control)Present0.0 percentage of eyes
Month 2Corneal Infiltrates - Enfilcon A Lens (Control)Absent100.0 percentage of eyes
Month 2Corneal Infiltrates - Enfilcon A Lens (Control)Present0.0 percentage of eyes
Month 3Corneal Infiltrates - Enfilcon A Lens (Control)Absent100.0 percentage of eyes
Month 3Corneal Infiltrates - Enfilcon A Lens (Control)Present0.0 percentage of eyes
UnscheduledCorneal Infiltrates - Enfilcon A Lens (Control)Absent100.0 percentage of eyes
UnscheduledCorneal Infiltrates - Enfilcon A Lens (Control)Present0.0 percentage of eyes
Primary

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.

ArmMeasureGroupValue (NUMBER)
BaselineCorneal Infiltrates - Fanfilcon A Lens (Test)Absent100.0 percentage of eyes
BaselineCorneal Infiltrates - Fanfilcon A Lens (Test)Present0.0 percentage of eyes
Week 1Corneal Infiltrates - Fanfilcon A Lens (Test)Absent100.0 percentage of eyes
Week 1Corneal Infiltrates - Fanfilcon A Lens (Test)Present0.0 percentage of eyes
Week 2Corneal Infiltrates - Fanfilcon A Lens (Test)Absent100.0 percentage of eyes
Week 2Corneal Infiltrates - Fanfilcon A Lens (Test)Present0.0 percentage of eyes
Month 1Corneal Infiltrates - Fanfilcon A Lens (Test)Absent100.0 percentage of eyes
Month 1Corneal Infiltrates - Fanfilcon A Lens (Test)Present0.0 percentage of eyes
Month 2Corneal Infiltrates - Fanfilcon A Lens (Test)Absent100.0 percentage of eyes
Month 2Corneal Infiltrates - Fanfilcon A Lens (Test)Present0.0 percentage of eyes
Month 3Corneal Infiltrates - Fanfilcon A Lens (Test)Absent100.0 percentage of eyes
Month 3Corneal Infiltrates - Fanfilcon A Lens (Test)Present0.0 percentage of eyes
UnscheduledCorneal Infiltrates - Fanfilcon A Lens (Test)Absent100.0 percentage of eyes
UnscheduledCorneal Infiltrates - Fanfilcon A Lens (Test)Present0.0 percentage of eyes
Primary

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.

ArmMeasureGroupValue (NUMBER)
BaselineCorneal Staining - Enfilcon A Lens (Control)Temporal - Moderate0.0 percentage of eyes
BaselineCorneal Staining - Enfilcon A Lens (Control)Inferior - Mild0.0 percentage of eyes
BaselineCorneal Staining - Enfilcon A Lens (Control)Inferior - Trace48.3 percentage of eyes
BaselineCorneal Staining - Enfilcon A Lens (Control)Superior - Severe0.0 percentage of eyes
BaselineCorneal Staining - Enfilcon A Lens (Control)Superior - Moderate0.0 percentage of eyes
BaselineCorneal Staining - Enfilcon A Lens (Control)Central - Mild0.0 percentage of eyes
BaselineCorneal Staining - Enfilcon A Lens (Control)Superior - None75.9 percentage of eyes
BaselineCorneal Staining - Enfilcon A Lens (Control)Nasal - Mild0.0 percentage of eyes
BaselineCorneal Staining - Enfilcon A Lens (Control)Nasal - Trace37.9 percentage of eyes
BaselineCorneal Staining - Enfilcon A Lens (Control)Inferior - None51.7 percentage of eyes
BaselineCorneal Staining - Enfilcon A Lens (Control)Temporal - None65.5 percentage of eyes
BaselineCorneal Staining - Enfilcon A Lens (Control)Central - None62.1 percentage of eyes
BaselineCorneal Staining - Enfilcon A Lens (Control)Temporal - Severe0.0 percentage of eyes
BaselineCorneal Staining - Enfilcon A Lens (Control)Inferior - Superior0.0 percentage of eyes
BaselineCorneal Staining - Enfilcon A Lens (Control)Inferior - Moderate0.0 percentage of eyes
BaselineCorneal Staining - Enfilcon A Lens (Control)Central - Severe0.0 percentage of eyes
BaselineCorneal Staining - Enfilcon A Lens (Control)Nasal - Severe0.0 percentage of eyes
BaselineCorneal Staining - Enfilcon A Lens (Control)Temporal - Trace34.5 percentage of eyes
BaselineCorneal Staining - Enfilcon A Lens (Control)Central - Trace37.9 percentage of eyes
BaselineCorneal Staining - Enfilcon A Lens (Control)Central - Moderate0.0 percentage of eyes
BaselineCorneal Staining - Enfilcon A Lens (Control)Superior - Trace24.1 percentage of eyes
BaselineCorneal Staining - Enfilcon A Lens (Control)Superior - Mild0.0 percentage of eyes
BaselineCorneal Staining - Enfilcon A Lens (Control)Nasal - None62.1 percentage of eyes
BaselineCorneal Staining - Enfilcon A Lens (Control)Nasal - Moderate0.0 percentage of eyes
BaselineCorneal Staining - Enfilcon A Lens (Control)Temporal - Mild0.0 percentage of eyes
Week 1Corneal Staining - Enfilcon A Lens (Control)Temporal - Trace15.4 percentage of eyes
Week 1Corneal Staining - Enfilcon A Lens (Control)Superior - Mild0.0 percentage of eyes
Week 1Corneal Staining - Enfilcon A Lens (Control)Superior - Trace15.4 percentage of eyes
Week 1Corneal Staining - Enfilcon A Lens (Control)Central - Severe0.0 percentage of eyes
Week 1Corneal Staining - Enfilcon A Lens (Control)Nasal - Mild3.8 percentage of eyes
Week 1Corneal Staining - Enfilcon A Lens (Control)Temporal - Moderate0.0 percentage of eyes
Week 1Corneal Staining - Enfilcon A Lens (Control)Superior - None84.6 percentage of eyes
Week 1Corneal Staining - Enfilcon A Lens (Control)Inferior - Moderate0.0 percentage of eyes
Week 1Corneal Staining - Enfilcon A Lens (Control)Inferior - Mild7.7 percentage of eyes
Week 1Corneal Staining - Enfilcon A Lens (Control)Nasal - Trace26.9 percentage of eyes
Week 1Corneal Staining - Enfilcon A Lens (Control)Temporal - Severe0.0 percentage of eyes
Week 1Corneal Staining - Enfilcon A Lens (Control)Superior - Moderate0.0 percentage of eyes
Week 1Corneal Staining - Enfilcon A Lens (Control)Nasal - None73.0 percentage of eyes
Week 1Corneal Staining - Enfilcon A Lens (Control)Central - None73.1 percentage of eyes
Week 1Corneal Staining - Enfilcon A Lens (Control)Central - Moderate0.0 percentage of eyes
Week 1Corneal Staining - Enfilcon A Lens (Control)Inferior - Trace42.3 percentage of eyes
Week 1Corneal Staining - Enfilcon A Lens (Control)Superior - Severe0.0 percentage of eyes
Week 1Corneal Staining - Enfilcon A Lens (Control)Inferior - Superior0.0 percentage of eyes
Week 1Corneal Staining - Enfilcon A Lens (Control)Central - Mild0.0 percentage of eyes
Week 1Corneal Staining - Enfilcon A Lens (Control)Inferior - None57.6 percentage of eyes
Week 1Corneal Staining - Enfilcon A Lens (Control)Temporal - None84.6 percentage of eyes
Week 1Corneal Staining - Enfilcon A Lens (Control)Central - Trace26.9 percentage of eyes
Week 1Corneal Staining - Enfilcon A Lens (Control)Nasal - Severe0.0 percentage of eyes
Week 1Corneal Staining - Enfilcon A Lens (Control)Temporal - Mild0.0 percentage of eyes
Week 1Corneal Staining - Enfilcon A Lens (Control)Nasal - Moderate0.0 percentage of eyes
Week 2Corneal Staining - Enfilcon A Lens (Control)Nasal - Moderate0.0 percentage of eyes
Week 2Corneal Staining - Enfilcon A Lens (Control)Central - Trace20.7 percentage of eyes
Week 2Corneal Staining - Enfilcon A Lens (Control)Central - Moderate0.0 percentage of eyes
Week 2Corneal Staining - Enfilcon A Lens (Control)Central - Mild0.0 percentage of eyes
Week 2Corneal Staining - Enfilcon A Lens (Control)Superior - Mild0.0 percentage of eyes
Week 2Corneal Staining - Enfilcon A Lens (Control)Inferior - Mild3.4 percentage of eyes
Week 2Corneal Staining - Enfilcon A Lens (Control)Superior - Moderate0.0 percentage of eyes
Week 2Corneal Staining - Enfilcon A Lens (Control)Inferior - Superior0.0 percentage of eyes
Week 2Corneal Staining - Enfilcon A Lens (Control)Inferior - Trace72.4 percentage of eyes
Week 2Corneal Staining - Enfilcon A Lens (Control)Superior - Severe0.0 percentage of eyes
Week 2Corneal Staining - Enfilcon A Lens (Control)Inferior - None27.6 percentage of eyes
Week 2Corneal Staining - Enfilcon A Lens (Control)Temporal - None75.9 percentage of eyes
Week 2Corneal Staining - Enfilcon A Lens (Control)Nasal - Severe0.0 percentage of eyes
Week 2Corneal Staining - Enfilcon A Lens (Control)Temporal - Trace24.1 percentage of eyes
Week 2Corneal Staining - Enfilcon A Lens (Control)Central - Severe0.0 percentage of eyes
Week 2Corneal Staining - Enfilcon A Lens (Control)Temporal - Mild0.0 percentage of eyes
Week 2Corneal Staining - Enfilcon A Lens (Control)Nasal - Mild0.0 percentage of eyes
Week 2Corneal Staining - Enfilcon A Lens (Control)Temporal - Moderate0.0 percentage of eyes
Week 2Corneal Staining - Enfilcon A Lens (Control)Superior - Trace3.4 percentage of eyes
Week 2Corneal Staining - Enfilcon A Lens (Control)Nasal - Trace34.5 percentage of eyes
Week 2Corneal Staining - Enfilcon A Lens (Control)Temporal - Severe0.0 percentage of eyes
Week 2Corneal Staining - Enfilcon A Lens (Control)Superior - None96.6 percentage of eyes
Week 2Corneal Staining - Enfilcon A Lens (Control)Nasal - None65.5 percentage of eyes
Week 2Corneal Staining - Enfilcon A Lens (Control)Central - None79.3 percentage of eyes
Week 2Corneal Staining - Enfilcon A Lens (Control)Inferior - Moderate0.0 percentage of eyes
Month 1Corneal Staining - Enfilcon A Lens (Control)Nasal - None79.3 percentage of eyes
Month 1Corneal Staining - Enfilcon A Lens (Control)Superior - None93.1 percentage of eyes
Month 1Corneal Staining - Enfilcon A Lens (Control)Superior - Trace6.9 percentage of eyes
Month 1Corneal Staining - Enfilcon A Lens (Control)Superior - Mild0.0 percentage of eyes
Month 1Corneal Staining - Enfilcon A Lens (Control)Superior - Moderate0.0 percentage of eyes
Month 1Corneal Staining - Enfilcon A Lens (Control)Superior - Severe0.0 percentage of eyes
Month 1Corneal Staining - Enfilcon A Lens (Control)Temporal - None89.7 percentage of eyes
Month 1Corneal Staining - Enfilcon A Lens (Control)Temporal - Trace10.3 percentage of eyes
Month 1Corneal Staining - Enfilcon A Lens (Control)Temporal - Mild0.0 percentage of eyes
Month 1Corneal Staining - Enfilcon A Lens (Control)Temporal - Moderate0.0 percentage of eyes
Month 1Corneal Staining - Enfilcon A Lens (Control)Temporal - Severe0.0 percentage of eyes
Month 1Corneal Staining - Enfilcon A Lens (Control)Central - None75.8 percentage of eyes
Month 1Corneal Staining - Enfilcon A Lens (Control)Central - Trace24.1 percentage of eyes
Month 1Corneal Staining - Enfilcon A Lens (Control)Central - Mild3.4 percentage of eyes
Month 1Corneal Staining - Enfilcon A Lens (Control)Central - Moderate0.0 percentage of eyes
Month 1Corneal Staining - Enfilcon A Lens (Control)Central - Severe0.0 percentage of eyes
Month 1Corneal Staining - Enfilcon A Lens (Control)Nasal - Trace20.7 percentage of eyes
Month 1Corneal Staining - Enfilcon A Lens (Control)Nasal - Mild0.0 percentage of eyes
Month 1Corneal Staining - Enfilcon A Lens (Control)Nasal - Moderate0.0 percentage of eyes
Month 1Corneal Staining - Enfilcon A Lens (Control)Nasal - Severe0.0 percentage of eyes
Month 1Corneal Staining - Enfilcon A Lens (Control)Inferior - None62.0 percentage of eyes
Month 1Corneal Staining - Enfilcon A Lens (Control)Inferior - Trace37.9 percentage of eyes
Month 1Corneal Staining - Enfilcon A Lens (Control)Inferior - Mild10.3 percentage of eyes
Month 1Corneal Staining - Enfilcon A Lens (Control)Inferior - Moderate0.0 percentage of eyes
Month 1Corneal Staining - Enfilcon A Lens (Control)Inferior - Superior0.0 percentage of eyes
Month 2Corneal Staining - Enfilcon A Lens (Control)Inferior - Trace46.4 percentage of eyes
Month 2Corneal Staining - Enfilcon A Lens (Control)Superior - Moderate0.0 percentage of eyes
Month 2Corneal Staining - Enfilcon A Lens (Control)Nasal - None78.6 percentage of eyes
Month 2Corneal Staining - Enfilcon A Lens (Control)Temporal - Trace25.0 percentage of eyes
Month 2Corneal Staining - Enfilcon A Lens (Control)Inferior - None53.5 percentage of eyes
Month 2Corneal Staining - Enfilcon A Lens (Control)Nasal - Moderate0.0 percentage of eyes
Month 2Corneal Staining - Enfilcon A Lens (Control)Inferior - Moderate0.0 percentage of eyes
Month 2Corneal Staining - Enfilcon A Lens (Control)Superior - None78.6 percentage of eyes
Month 2Corneal Staining - Enfilcon A Lens (Control)Superior - Severe0.0 percentage of eyes
Month 2Corneal Staining - Enfilcon A Lens (Control)Central - Mild0.0 percentage of eyes
Month 2Corneal Staining - Enfilcon A Lens (Control)Temporal - None75.0 percentage of eyes
Month 2Corneal Staining - Enfilcon A Lens (Control)Superior - Trace21.4 percentage of eyes
Month 2Corneal Staining - Enfilcon A Lens (Control)Nasal - Severe0.0 percentage of eyes
Month 2Corneal Staining - Enfilcon A Lens (Control)Central - Trace14.3 percentage of eyes
Month 2Corneal Staining - Enfilcon A Lens (Control)Temporal - Moderate0.0 percentage of eyes
Month 2Corneal Staining - Enfilcon A Lens (Control)Central - None85.7 percentage of eyes
Month 2Corneal Staining - Enfilcon A Lens (Control)Nasal - Trace21.4 percentage of eyes
Month 2Corneal Staining - Enfilcon A Lens (Control)Central - Moderate0.0 percentage of eyes
Month 2Corneal Staining - Enfilcon A Lens (Control)Inferior - Mild3.6 percentage of eyes
Month 2Corneal Staining - Enfilcon A Lens (Control)Inferior - Superior0.0 percentage of eyes
Month 2Corneal Staining - Enfilcon A Lens (Control)Central - Severe0.0 percentage of eyes
Month 2Corneal Staining - Enfilcon A Lens (Control)Temporal - Mild0.0 percentage of eyes
Month 2Corneal Staining - Enfilcon A Lens (Control)Superior - Mild0.0 percentage of eyes
Month 2Corneal Staining - Enfilcon A Lens (Control)Nasal - Mild0.0 percentage of eyes
Month 2Corneal Staining - Enfilcon A Lens (Control)Temporal - Severe0.0 percentage of eyes
Month 3Corneal Staining - Enfilcon A Lens (Control)Central - None82.8 percentage of eyes
Month 3Corneal Staining - Enfilcon A Lens (Control)Central - Severe0.0 percentage of eyes
Month 3Corneal Staining - Enfilcon A Lens (Control)Temporal - Severe0.0 percentage of eyes
Month 3Corneal Staining - Enfilcon A Lens (Control)Nasal - None75.9 percentage of eyes
Month 3Corneal Staining - Enfilcon A Lens (Control)Temporal - Moderate0.0 percentage of eyes
Month 3Corneal Staining - Enfilcon A Lens (Control)Inferior - Moderate0.0 percentage of eyes
Month 3Corneal Staining - Enfilcon A Lens (Control)Nasal - Trace24.1 percentage of eyes
Month 3Corneal Staining - Enfilcon A Lens (Control)Temporal - Mild6.9 percentage of eyes
Month 3Corneal Staining - Enfilcon A Lens (Control)Nasal - Mild1.8 percentage of eyes
Month 3Corneal Staining - Enfilcon A Lens (Control)Temporal - Trace10.3 percentage of eyes
Month 3Corneal Staining - Enfilcon A Lens (Control)Nasal - Moderate0.0 percentage of eyes
Month 3Corneal Staining - Enfilcon A Lens (Control)Temporal - None89.6 percentage of eyes
Month 3Corneal Staining - Enfilcon A Lens (Control)Superior - None93.1 percentage of eyes
Month 3Corneal Staining - Enfilcon A Lens (Control)Nasal - Severe0.0 percentage of eyes
Month 3Corneal Staining - Enfilcon A Lens (Control)Superior - Severe0.0 percentage of eyes
Month 3Corneal Staining - Enfilcon A Lens (Control)Inferior - None44.8 percentage of eyes
Month 3Corneal Staining - Enfilcon A Lens (Control)Superior - Moderate0.0 percentage of eyes
Month 3Corneal Staining - Enfilcon A Lens (Control)Inferior - Trace55.2 percentage of eyes
Month 3Corneal Staining - Enfilcon A Lens (Control)Superior - Mild0.0 percentage of eyes
Month 3Corneal Staining - Enfilcon A Lens (Control)Inferior - Mild3.4 percentage of eyes
Month 3Corneal Staining - Enfilcon A Lens (Control)Superior - Trace6.9 percentage of eyes
Month 3Corneal Staining - Enfilcon A Lens (Control)Central - Mild0.0 percentage of eyes
Month 3Corneal Staining - Enfilcon A Lens (Control)Central - Trace17.2 percentage of eyes
Month 3Corneal Staining - Enfilcon A Lens (Control)Inferior - Superior0.0 percentage of eyes
Month 3Corneal Staining - Enfilcon A Lens (Control)Central - Moderate0.0 percentage of eyes
UnscheduledCorneal Staining - Enfilcon A Lens (Control)Inferior - Superior0.0 percentage of eyes
UnscheduledCorneal Staining - Enfilcon A Lens (Control)Nasal - Mild0.0 percentage of eyes
UnscheduledCorneal Staining - Enfilcon A Lens (Control)Central - Trace8.3 percentage of eyes
UnscheduledCorneal Staining - Enfilcon A Lens (Control)Inferior - Trace33.3 percentage of eyes
UnscheduledCorneal Staining - Enfilcon A Lens (Control)Superior - Mild0.0 percentage of eyes
UnscheduledCorneal Staining - Enfilcon A Lens (Control)Central - Moderate0.0 percentage of eyes
UnscheduledCorneal Staining - Enfilcon A Lens (Control)Inferior - Moderate0.0 percentage of eyes
UnscheduledCorneal Staining - Enfilcon A Lens (Control)Temporal - Mild0.0 percentage of eyes
UnscheduledCorneal Staining - Enfilcon A Lens (Control)Nasal - Trace0.0 percentage of eyes
UnscheduledCorneal Staining - Enfilcon A Lens (Control)Central - Severe0.0 percentage of eyes
UnscheduledCorneal Staining - Enfilcon A Lens (Control)Inferior - Mild0.0 percentage of eyes
UnscheduledCorneal Staining - Enfilcon A Lens (Control)Superior - Trace0.0 percentage of eyes
UnscheduledCorneal Staining - Enfilcon A Lens (Control)Temporal - Severe0.0 percentage of eyes
UnscheduledCorneal Staining - Enfilcon A Lens (Control)Temporal - Moderate0.0 percentage of eyes
UnscheduledCorneal Staining - Enfilcon A Lens (Control)Nasal - Severe0.0 percentage of eyes
UnscheduledCorneal Staining - Enfilcon A Lens (Control)Superior - Severe0.0 percentage of eyes
UnscheduledCorneal Staining - Enfilcon A Lens (Control)Central - None83.4 percentage of eyes
UnscheduledCorneal Staining - Enfilcon A Lens (Control)Temporal - None100.0 percentage of eyes
UnscheduledCorneal Staining - Enfilcon A Lens (Control)Nasal - Moderate0.0 percentage of eyes
UnscheduledCorneal Staining - Enfilcon A Lens (Control)Superior - None100.0 percentage of eyes
UnscheduledCorneal Staining - Enfilcon A Lens (Control)Central - Mild8.3 percentage of eyes
UnscheduledCorneal Staining - Enfilcon A Lens (Control)Inferior - None66.7 percentage of eyes
UnscheduledCorneal Staining - Enfilcon A Lens (Control)Superior - Moderate0.0 percentage of eyes
UnscheduledCorneal Staining - Enfilcon A Lens (Control)Nasal - None100.0 percentage of eyes
UnscheduledCorneal Staining - Enfilcon A Lens (Control)Temporal - Trace0.0 percentage of eyes
Primary

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

ArmMeasureGroupValue (NUMBER)
BaselineCorneal Staining - Fanfilcon A Lens (Test)Temporal - Moderate0.0 percentage of eyes
BaselineCorneal Staining - Fanfilcon A Lens (Test)Inferior - Mild0.0 percentage of eyes
BaselineCorneal Staining - Fanfilcon A Lens (Test)Inferior - Trace29.6 percentage of eyes
BaselineCorneal Staining - Fanfilcon A Lens (Test)Superior - Severe0.0 percentage of eyes
BaselineCorneal Staining - Fanfilcon A Lens (Test)Superior - Moderate0.0 percentage of eyes
BaselineCorneal Staining - Fanfilcon A Lens (Test)Central - Mild0.0 percentage of eyes
BaselineCorneal Staining - Fanfilcon A Lens (Test)Superior - None96.3 percentage of eyes
BaselineCorneal Staining - Fanfilcon A Lens (Test)Nasal - Mild0.0 percentage of eyes
BaselineCorneal Staining - Fanfilcon A Lens (Test)Nasal - Trace9.3 percentage of eyes
BaselineCorneal Staining - Fanfilcon A Lens (Test)Inferior - None70.4 percentage of eyes
BaselineCorneal Staining - Fanfilcon A Lens (Test)Temporal - None93.5 percentage of eyes
BaselineCorneal Staining - Fanfilcon A Lens (Test)Central - None94.4 percentage of eyes
BaselineCorneal Staining - Fanfilcon A Lens (Test)Temporal - Severe0.0 percentage of eyes
BaselineCorneal Staining - Fanfilcon A Lens (Test)Inferior - Severe0.0 percentage of eyes
BaselineCorneal Staining - Fanfilcon A Lens (Test)Inferior - Moderate0.0 percentage of eyes
BaselineCorneal Staining - Fanfilcon A Lens (Test)Central - Severe0.0 percentage of eyes
BaselineCorneal Staining - Fanfilcon A Lens (Test)Nasal - Severe0.0 percentage of eyes
BaselineCorneal Staining - Fanfilcon A Lens (Test)Temporal - Trace6.5 percentage of eyes
BaselineCorneal Staining - Fanfilcon A Lens (Test)Central - Trace5.6 percentage of eyes
BaselineCorneal Staining - Fanfilcon A Lens (Test)Central - Moderate0.0 percentage of eyes
BaselineCorneal Staining - Fanfilcon A Lens (Test)Superior - Trace3.7 percentage of eyes
BaselineCorneal Staining - Fanfilcon A Lens (Test)Superior - Mild0.0 percentage of eyes
BaselineCorneal Staining - Fanfilcon A Lens (Test)Nasal - None90.7 percentage of eyes
BaselineCorneal Staining - Fanfilcon A Lens (Test)Nasal - Moderate0.0 percentage of eyes
BaselineCorneal Staining - Fanfilcon A Lens (Test)Temporal - Mild0.0 percentage of eyes
Week 1Corneal Staining - Fanfilcon A Lens (Test)Temporal - Trace2.8 percentage of eyes
Week 1Corneal Staining - Fanfilcon A Lens (Test)Superior - Mild0.0 percentage of eyes
Week 1Corneal Staining - Fanfilcon A Lens (Test)Superior - Trace7.4 percentage of eyes
Week 1Corneal Staining - Fanfilcon A Lens (Test)Central - Severe0.0 percentage of eyes
Week 1Corneal Staining - Fanfilcon A Lens (Test)Nasal - Mild1.9 percentage of eyes
Week 1Corneal Staining - Fanfilcon A Lens (Test)Temporal - Moderate0.0 percentage of eyes
Week 1Corneal Staining - Fanfilcon A Lens (Test)Superior - None92.6 percentage of eyes
Week 1Corneal Staining - Fanfilcon A Lens (Test)Inferior - Moderate0.0 percentage of eyes
Week 1Corneal Staining - Fanfilcon A Lens (Test)Inferior - Mild0.9 percentage of eyes
Week 1Corneal Staining - Fanfilcon A Lens (Test)Nasal - Trace7.4 percentage of eyes
Week 1Corneal Staining - Fanfilcon A Lens (Test)Temporal - Severe0.0 percentage of eyes
Week 1Corneal Staining - Fanfilcon A Lens (Test)Superior - Moderate0.0 percentage of eyes
Week 1Corneal Staining - Fanfilcon A Lens (Test)Nasal - None90.7 percentage of eyes
Week 1Corneal Staining - Fanfilcon A Lens (Test)Central - None88.9 percentage of eyes
Week 1Corneal Staining - Fanfilcon A Lens (Test)Central - Moderate0.0 percentage of eyes
Week 1Corneal Staining - Fanfilcon A Lens (Test)Inferior - Trace28.7 percentage of eyes
Week 1Corneal Staining - Fanfilcon A Lens (Test)Superior - Severe0.0 percentage of eyes
Week 1Corneal Staining - Fanfilcon A Lens (Test)Inferior - Severe0.0 percentage of eyes
Week 1Corneal Staining - Fanfilcon A Lens (Test)Central - Mild0.0 percentage of eyes
Week 1Corneal Staining - Fanfilcon A Lens (Test)Inferior - None70.4 percentage of eyes
Week 1Corneal Staining - Fanfilcon A Lens (Test)Temporal - None97.2 percentage of eyes
Week 1Corneal Staining - Fanfilcon A Lens (Test)Central - Trace11.1 percentage of eyes
Week 1Corneal Staining - Fanfilcon A Lens (Test)Nasal - Severe0.0 percentage of eyes
Week 1Corneal Staining - Fanfilcon A Lens (Test)Temporal - Mild0.0 percentage of eyes
Week 1Corneal Staining - Fanfilcon A Lens (Test)Nasal - Moderate0.0 percentage of eyes
Week 2Corneal Staining - Fanfilcon A Lens (Test)Nasal - Moderate0.0 percentage of eyes
Week 2Corneal Staining - Fanfilcon A Lens (Test)Central - Trace10.4 percentage of eyes
Week 2Corneal Staining - Fanfilcon A Lens (Test)Central - Moderate0.0 percentage of eyes
Week 2Corneal Staining - Fanfilcon A Lens (Test)Central - Mild0.9 percentage of eyes
Week 2Corneal Staining - Fanfilcon A Lens (Test)Superior - Mild3.8 percentage of eyes
Week 2Corneal Staining - Fanfilcon A Lens (Test)Inferior - Mild6.6 percentage of eyes
Week 2Corneal Staining - Fanfilcon A Lens (Test)Superior - Moderate0.0 percentage of eyes
Week 2Corneal Staining - Fanfilcon A Lens (Test)Inferior - Severe0.0 percentage of eyes
Week 2Corneal Staining - Fanfilcon A Lens (Test)Inferior - Trace21.7 percentage of eyes
Week 2Corneal Staining - Fanfilcon A Lens (Test)Superior - Severe0.0 percentage of eyes
Week 2Corneal Staining - Fanfilcon A Lens (Test)Inferior - None71.7 percentage of eyes
Week 2Corneal Staining - Fanfilcon A Lens (Test)Temporal - None95.3 percentage of eyes
Week 2Corneal Staining - Fanfilcon A Lens (Test)Nasal - Severe0.0 percentage of eyes
Week 2Corneal Staining - Fanfilcon A Lens (Test)Temporal - Trace3.8 percentage of eyes
Week 2Corneal Staining - Fanfilcon A Lens (Test)Central - Severe0.0 percentage of eyes
Week 2Corneal Staining - Fanfilcon A Lens (Test)Temporal - Mild0.9 percentage of eyes
Week 2Corneal Staining - Fanfilcon A Lens (Test)Nasal - Mild0.0 percentage of eyes
Week 2Corneal Staining - Fanfilcon A Lens (Test)Temporal - Moderate0.0 percentage of eyes
Week 2Corneal Staining - Fanfilcon A Lens (Test)Superior - Trace2.8 percentage of eyes
Week 2Corneal Staining - Fanfilcon A Lens (Test)Nasal - Trace3.8 percentage of eyes
Week 2Corneal Staining - Fanfilcon A Lens (Test)Temporal - Severe0.0 percentage of eyes
Week 2Corneal Staining - Fanfilcon A Lens (Test)Superior - None93.4 percentage of eyes
Week 2Corneal Staining - Fanfilcon A Lens (Test)Nasal - None96.2 percentage of eyes
Week 2Corneal Staining - Fanfilcon A Lens (Test)Central - None88.7 percentage of eyes
Week 2Corneal Staining - Fanfilcon A Lens (Test)Inferior - Moderate0.0 percentage of eyes
Month 1Corneal Staining - Fanfilcon A Lens (Test)Nasal - None92.6 percentage of eyes
Month 1Corneal Staining - Fanfilcon A Lens (Test)Superior - None93.5 percentage of eyes
Month 1Corneal Staining - Fanfilcon A Lens (Test)Superior - Trace6.5 percentage of eyes
Month 1Corneal Staining - Fanfilcon A Lens (Test)Superior - Mild0 percentage of eyes
Month 1Corneal Staining - Fanfilcon A Lens (Test)Superior - Moderate0.0 percentage of eyes
Month 1Corneal Staining - Fanfilcon A Lens (Test)Superior - Severe0.0 percentage of eyes
Month 1Corneal Staining - Fanfilcon A Lens (Test)Temporal - None96.3 percentage of eyes
Month 1Corneal Staining - Fanfilcon A Lens (Test)Temporal - Trace2.8 percentage of eyes
Month 1Corneal Staining - Fanfilcon A Lens (Test)Temporal - Mild0.9 percentage of eyes
Month 1Corneal Staining - Fanfilcon A Lens (Test)Temporal - Moderate0.0 percentage of eyes
Month 1Corneal Staining - Fanfilcon A Lens (Test)Temporal - Severe0.0 percentage of eyes
Month 1Corneal Staining - Fanfilcon A Lens (Test)Central - None88.0 percentage of eyes
Month 1Corneal Staining - Fanfilcon A Lens (Test)Central - Trace11.1 percentage of eyes
Month 1Corneal Staining - Fanfilcon A Lens (Test)Central - Mild0.9 percentage of eyes
Month 1Corneal Staining - Fanfilcon A Lens (Test)Central - Moderate0.0 percentage of eyes
Month 1Corneal Staining - Fanfilcon A Lens (Test)Central - Severe0.0 percentage of eyes
Month 1Corneal Staining - Fanfilcon A Lens (Test)Nasal - Trace5.6 percentage of eyes
Month 1Corneal Staining - Fanfilcon A Lens (Test)Nasal - Mild1.9 percentage of eyes
Month 1Corneal Staining - Fanfilcon A Lens (Test)Nasal - Moderate0.0 percentage of eyes
Month 1Corneal Staining - Fanfilcon A Lens (Test)Nasal - Severe0.0 percentage of eyes
Month 1Corneal Staining - Fanfilcon A Lens (Test)Inferior - None74.1 percentage of eyes
Month 1Corneal Staining - Fanfilcon A Lens (Test)Inferior - Trace17.6 percentage of eyes
Month 1Corneal Staining - Fanfilcon A Lens (Test)Inferior - Mild8.3 percentage of eyes
Month 1Corneal Staining - Fanfilcon A Lens (Test)Inferior - Moderate0.0 percentage of eyes
Month 1Corneal Staining - Fanfilcon A Lens (Test)Inferior - Severe0.0 percentage of eyes
Month 2Corneal Staining - Fanfilcon A Lens (Test)Inferior - Trace23.1 percentage of eyes
Month 2Corneal Staining - Fanfilcon A Lens (Test)Superior - Moderate0.0 percentage of eyes
Month 2Corneal Staining - Fanfilcon A Lens (Test)Nasal - None95.4 percentage of eyes
Month 2Corneal Staining - Fanfilcon A Lens (Test)Temporal - Trace5.6 percentage of eyes
Month 2Corneal Staining - Fanfilcon A Lens (Test)Inferior - None67.6 percentage of eyes
Month 2Corneal Staining - Fanfilcon A Lens (Test)Nasal - Moderate0.0 percentage of eyes
Month 2Corneal Staining - Fanfilcon A Lens (Test)Inferior - Moderate0.0 percentage of eyes
Month 2Corneal Staining - Fanfilcon A Lens (Test)Superior - None97.2 percentage of eyes
Month 2Corneal Staining - Fanfilcon A Lens (Test)Superior - Severe0.0 percentage of eyes
Month 2Corneal Staining - Fanfilcon A Lens (Test)Central - Mild1.9 percentage of eyes
Month 2Corneal Staining - Fanfilcon A Lens (Test)Temporal - None92.6 percentage of eyes
Month 2Corneal Staining - Fanfilcon A Lens (Test)Superior - Trace2.8 percentage of eyes
Month 2Corneal Staining - Fanfilcon A Lens (Test)Nasal - Severe0.0 percentage of eyes
Month 2Corneal Staining - Fanfilcon A Lens (Test)Central - Trace2.8 percentage of eyes
Month 2Corneal Staining - Fanfilcon A Lens (Test)Temporal - Moderate0.0 percentage of eyes
Month 2Corneal Staining - Fanfilcon A Lens (Test)Central - None95.4 percentage of eyes
Month 2Corneal Staining - Fanfilcon A Lens (Test)Nasal - Trace3.7 percentage of eyes
Month 2Corneal Staining - Fanfilcon A Lens (Test)Central - Moderate0.0 percentage of eyes
Month 2Corneal Staining - Fanfilcon A Lens (Test)Inferior - Mild9.3 percentage of eyes
Month 2Corneal Staining - Fanfilcon A Lens (Test)Inferior - Severe0.0 percentage of eyes
Month 2Corneal Staining - Fanfilcon A Lens (Test)Central - Severe0.0 percentage of eyes
Month 2Corneal Staining - Fanfilcon A Lens (Test)Temporal - Mild1.9 percentage of eyes
Month 2Corneal Staining - Fanfilcon A Lens (Test)Superior - Mild0 percentage of eyes
Month 2Corneal Staining - Fanfilcon A Lens (Test)Nasal - Mild0.9 percentage of eyes
Month 2Corneal Staining - Fanfilcon A Lens (Test)Temporal - Severe0.0 percentage of eyes
Month 3Corneal Staining - Fanfilcon A Lens (Test)Central - None88.9 percentage of eyes
Month 3Corneal Staining - Fanfilcon A Lens (Test)Central - Severe0.0 percentage of eyes
Month 3Corneal Staining - Fanfilcon A Lens (Test)Temporal - Severe0.0 percentage of eyes
Month 3Corneal Staining - Fanfilcon A Lens (Test)Nasal - None96.3 percentage of eyes
Month 3Corneal Staining - Fanfilcon A Lens (Test)Temporal - Moderate0.0 percentage of eyes
Month 3Corneal Staining - Fanfilcon A Lens (Test)Inferior - Moderate0.0 percentage of eyes
Month 3Corneal Staining - Fanfilcon A Lens (Test)Nasal - Trace3.7 percentage of eyes
Month 3Corneal Staining - Fanfilcon A Lens (Test)Temporal - Mild0.9 percentage of eyes
Month 3Corneal Staining - Fanfilcon A Lens (Test)Nasal - Mild0.0 percentage of eyes
Month 3Corneal Staining - Fanfilcon A Lens (Test)Temporal - Trace8.3 percentage of eyes
Month 3Corneal Staining - Fanfilcon A Lens (Test)Nasal - Moderate0.0 percentage of eyes
Month 3Corneal Staining - Fanfilcon A Lens (Test)Temporal - None90.7 percentage of eyes
Month 3Corneal Staining - Fanfilcon A Lens (Test)Superior - None96.3 percentage of eyes
Month 3Corneal Staining - Fanfilcon A Lens (Test)Nasal - Severe0.0 percentage of eyes
Month 3Corneal Staining - Fanfilcon A Lens (Test)Superior - Severe0.0 percentage of eyes
Month 3Corneal Staining - Fanfilcon A Lens (Test)Inferior - None70.4 percentage of eyes
Month 3Corneal Staining - Fanfilcon A Lens (Test)Superior - Moderate0.0 percentage of eyes
Month 3Corneal Staining - Fanfilcon A Lens (Test)Inferior - Trace23.1 percentage of eyes
Month 3Corneal Staining - Fanfilcon A Lens (Test)Superior - Mild0.9 percentage of eyes
Month 3Corneal Staining - Fanfilcon A Lens (Test)Inferior - Mild6.5 percentage of eyes
Month 3Corneal Staining - Fanfilcon A Lens (Test)Superior - Trace2.8 percentage of eyes
Month 3Corneal Staining - Fanfilcon A Lens (Test)Central - Mild0.0 percentage of eyes
Month 3Corneal Staining - Fanfilcon A Lens (Test)Central - Trace11.1 percentage of eyes
Month 3Corneal Staining - Fanfilcon A Lens (Test)Inferior - Severe0.0 percentage of eyes
Month 3Corneal Staining - Fanfilcon A Lens (Test)Central - Moderate0.0 percentage of eyes
UnscheduledCorneal Staining - Fanfilcon A Lens (Test)Inferior - Severe0.0 percentage of eyes
UnscheduledCorneal Staining - Fanfilcon A Lens (Test)Nasal - Mild0.0 percentage of eyes
UnscheduledCorneal Staining - Fanfilcon A Lens (Test)Central - Trace0.0 percentage of eyes
UnscheduledCorneal Staining - Fanfilcon A Lens (Test)Inferior - Trace0.0 percentage of eyes
UnscheduledCorneal Staining - Fanfilcon A Lens (Test)Superior - Mild0.0 percentage of eyes
UnscheduledCorneal Staining - Fanfilcon A Lens (Test)Central - Moderate0.0 percentage of eyes
UnscheduledCorneal Staining - Fanfilcon A Lens (Test)Inferior - Moderate0.0 percentage of eyes
UnscheduledCorneal Staining - Fanfilcon A Lens (Test)Temporal - Mild0.0 percentage of eyes
UnscheduledCorneal Staining - Fanfilcon A Lens (Test)Nasal - Trace0.0 percentage of eyes
UnscheduledCorneal Staining - Fanfilcon A Lens (Test)Central - Severe0.0 percentage of eyes
UnscheduledCorneal Staining - Fanfilcon A Lens (Test)Inferior - Mild0.0 percentage of eyes
UnscheduledCorneal Staining - Fanfilcon A Lens (Test)Superior - Trace0.0 percentage of eyes
UnscheduledCorneal Staining - Fanfilcon A Lens (Test)Temporal - Severe0.0 percentage of eyes
UnscheduledCorneal Staining - Fanfilcon A Lens (Test)Temporal - Moderate0.0 percentage of eyes
UnscheduledCorneal Staining - Fanfilcon A Lens (Test)Nasal - Severe0.0 percentage of eyes
UnscheduledCorneal Staining - Fanfilcon A Lens (Test)Superior - Severe0.0 percentage of eyes
UnscheduledCorneal Staining - Fanfilcon A Lens (Test)Central - None100.0 percentage of eyes
UnscheduledCorneal Staining - Fanfilcon A Lens (Test)Temporal - None100.0 percentage of eyes
UnscheduledCorneal Staining - Fanfilcon A Lens (Test)Nasal - Moderate0.0 percentage of eyes
UnscheduledCorneal Staining - Fanfilcon A Lens (Test)Superior - None100.0 percentage of eyes
UnscheduledCorneal Staining - Fanfilcon A Lens (Test)Central - Mild0.0 percentage of eyes
UnscheduledCorneal Staining - Fanfilcon A Lens (Test)Inferior - None100.0 percentage of eyes
UnscheduledCorneal Staining - Fanfilcon A Lens (Test)Superior - Moderate0.0 percentage of eyes
UnscheduledCorneal Staining - Fanfilcon A Lens (Test)Nasal - None100.0 percentage of eyes
UnscheduledCorneal Staining - Fanfilcon A Lens (Test)Temporal - Trace0.0 percentage of eyes
Primary

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.

ArmMeasureGroupValue (NUMBER)
BaselineCorneal Vascularization - Enfilcon A Lens (Control)Mild0.0 percentage of eyes
BaselineCorneal Vascularization - Enfilcon A Lens (Control)None86.2 percentage of eyes
BaselineCorneal Vascularization - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
BaselineCorneal Vascularization - Enfilcon A Lens (Control)Trace13.8 percentage of eyes
BaselineCorneal Vascularization - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
Week 1Corneal Vascularization - Enfilcon A Lens (Control)Mild0.0 percentage of eyes
Week 1Corneal Vascularization - Enfilcon A Lens (Control)Trace7.7 percentage of eyes
Week 1Corneal Vascularization - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
Week 1Corneal Vascularization - Enfilcon A Lens (Control)None92.3 percentage of eyes
Week 1Corneal Vascularization - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
Week 2Corneal Vascularization - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
Week 2Corneal Vascularization - Enfilcon A Lens (Control)Trace6.9 percentage of eyes
Week 2Corneal Vascularization - Enfilcon A Lens (Control)None93.1 percentage of eyes
Week 2Corneal Vascularization - Enfilcon A Lens (Control)Mild0.0 percentage of eyes
Week 2Corneal Vascularization - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
Month 1Corneal Vascularization - Enfilcon A Lens (Control)Mild0.0 percentage of eyes
Month 1Corneal Vascularization - Enfilcon A Lens (Control)None93.1 percentage of eyes
Month 1Corneal Vascularization - Enfilcon A Lens (Control)Trace6.9 percentage of eyes
Month 1Corneal Vascularization - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
Month 1Corneal Vascularization - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
Month 2Corneal Vascularization - Enfilcon A Lens (Control)None96.4 percentage of eyes
Month 2Corneal Vascularization - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
Month 2Corneal Vascularization - Enfilcon A Lens (Control)Mild0.0 percentage of eyes
Month 2Corneal Vascularization - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
Month 2Corneal Vascularization - Enfilcon A Lens (Control)Trace3.6 percentage of eyes
Month 3Corneal Vascularization - Enfilcon A Lens (Control)None96.6 percentage of eyes
Month 3Corneal Vascularization - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
Month 3Corneal Vascularization - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
Month 3Corneal Vascularization - Enfilcon A Lens (Control)Trace3.4 percentage of eyes
Month 3Corneal Vascularization - Enfilcon A Lens (Control)Mild0.0 percentage of eyes
UnscheduledCorneal Vascularization - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
UnscheduledCorneal Vascularization - Enfilcon A Lens (Control)Trace0.0 percentage of eyes
UnscheduledCorneal Vascularization - Enfilcon A Lens (Control)Mild0.0 percentage of eyes
UnscheduledCorneal Vascularization - Enfilcon A Lens (Control)None100.0 percentage of eyes
UnscheduledCorneal Vascularization - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
Primary

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.

ArmMeasureGroupValue (NUMBER)
BaselineCorneal Vascularization - Fanfilcon A Lens (Test)Mild0.0 percentage of eyes
BaselineCorneal Vascularization - Fanfilcon A Lens (Test)None90.7 percentage of eyes
BaselineCorneal Vascularization - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
BaselineCorneal Vascularization - Fanfilcon A Lens (Test)Trace9.3 percentage of eyes
BaselineCorneal Vascularization - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
Week 1Corneal Vascularization - Fanfilcon A Lens (Test)Mild0.0 percentage of eyes
Week 1Corneal Vascularization - Fanfilcon A Lens (Test)Trace7.4 percentage of eyes
Week 1Corneal Vascularization - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
Week 1Corneal Vascularization - Fanfilcon A Lens (Test)None92.6 percentage of eyes
Week 1Corneal Vascularization - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
Week 2Corneal Vascularization - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
Week 2Corneal Vascularization - Fanfilcon A Lens (Test)Trace7.5 percentage of eyes
Week 2Corneal Vascularization - Fanfilcon A Lens (Test)None92.5 percentage of eyes
Week 2Corneal Vascularization - Fanfilcon A Lens (Test)Mild0.0 percentage of eyes
Week 2Corneal Vascularization - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
Month 1Corneal Vascularization - Fanfilcon A Lens (Test)Mild0.0 percentage of eyes
Month 1Corneal Vascularization - Fanfilcon A Lens (Test)None92.6 percentage of eyes
Month 1Corneal Vascularization - Fanfilcon A Lens (Test)Trace7.4 percentage of eyes
Month 1Corneal Vascularization - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
Month 1Corneal Vascularization - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
Month 2Corneal Vascularization - Fanfilcon A Lens (Test)None94.4 percentage of eyes
Month 2Corneal Vascularization - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
Month 2Corneal Vascularization - Fanfilcon A Lens (Test)Mild0.0 percentage of eyes
Month 2Corneal Vascularization - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
Month 2Corneal Vascularization - Fanfilcon A Lens (Test)Trace5.6 percentage of eyes
Month 3Corneal Vascularization - Fanfilcon A Lens (Test)None91.7 percentage of eyes
Month 3Corneal Vascularization - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
Month 3Corneal Vascularization - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
Month 3Corneal Vascularization - Fanfilcon A Lens (Test)Trace8.3 percentage of eyes
Month 3Corneal Vascularization - Fanfilcon A Lens (Test)Mild0.0 percentage of eyes
UnscheduledCorneal Vascularization - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
UnscheduledCorneal Vascularization - Fanfilcon A Lens (Test)Trace0.0 percentage of eyes
UnscheduledCorneal Vascularization - Fanfilcon A Lens (Test)Mild0.0 percentage of eyes
UnscheduledCorneal Vascularization - Fanfilcon A Lens (Test)None100.0 percentage of eyes
UnscheduledCorneal Vascularization - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
Primary

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.

ArmMeasureGroupValue (NUMBER)
BaselineEpithelial Edema - Enfilcon A Lens (Control)None100.0 percentage of eyes
BaselineEpithelial Edema - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
BaselineEpithelial Edema - Enfilcon A Lens (Control)Trace0.0 percentage of eyes
BaselineEpithelial Edema - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
BaselineEpithelial Edema - Enfilcon A Lens (Control)MIld0.0 percentage of eyes
Week 1Epithelial Edema - Enfilcon A Lens (Control)None100.0 percentage of eyes
Week 1Epithelial Edema - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
Week 1Epithelial Edema - Enfilcon A Lens (Control)MIld0.0 percentage of eyes
Week 1Epithelial Edema - Enfilcon A Lens (Control)Trace0.0 percentage of eyes
Week 1Epithelial Edema - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
Week 2Epithelial Edema - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
Week 2Epithelial Edema - Enfilcon A Lens (Control)MIld0.0 percentage of eyes
Week 2Epithelial Edema - Enfilcon A Lens (Control)None100.0 percentage of eyes
Week 2Epithelial Edema - Enfilcon A Lens (Control)Trace0.0 percentage of eyes
Week 2Epithelial Edema - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
Month 1Epithelial Edema - Enfilcon A Lens (Control)Trace0.0 percentage of eyes
Month 1Epithelial Edema - Enfilcon A Lens (Control)MIld0.0 percentage of eyes
Month 1Epithelial Edema - Enfilcon A Lens (Control)None100.0 percentage of eyes
Month 1Epithelial Edema - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
Month 1Epithelial Edema - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
Month 2Epithelial Edema - Enfilcon A Lens (Control)Trace0.0 percentage of eyes
Month 2Epithelial Edema - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
Month 2Epithelial Edema - Enfilcon A Lens (Control)None100.0 percentage of eyes
Month 2Epithelial Edema - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
Month 2Epithelial Edema - Enfilcon A Lens (Control)MIld0.0 percentage of eyes
Month 3Epithelial Edema - Enfilcon A Lens (Control)Trace0.0 percentage of eyes
Month 3Epithelial Edema - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
Month 3Epithelial Edema - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
Month 3Epithelial Edema - Enfilcon A Lens (Control)MIld0.0 percentage of eyes
Month 3Epithelial Edema - Enfilcon A Lens (Control)None100.0 percentage of eyes
UnscheduledEpithelial Edema - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
UnscheduledEpithelial Edema - Enfilcon A Lens (Control)MIld0.0 percentage of eyes
UnscheduledEpithelial Edema - Enfilcon A Lens (Control)None100.0 percentage of eyes
UnscheduledEpithelial Edema - Enfilcon A Lens (Control)Trace0.0 percentage of eyes
UnscheduledEpithelial Edema - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
Primary

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.

ArmMeasureGroupValue (NUMBER)
BaselineEpithelial Edema - Fanfilcon A Lens (Test)Mild0.0 percentage of eyes
BaselineEpithelial Edema - Fanfilcon A Lens (Test)None100.0 percentage of eyes
BaselineEpithelial Edema - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
BaselineEpithelial Edema - Fanfilcon A Lens (Test)Trace0.0 percentage of eyes
BaselineEpithelial Edema - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
Week 1Epithelial Edema - Fanfilcon A Lens (Test)Mild0.0 percentage of eyes
Week 1Epithelial Edema - Fanfilcon A Lens (Test)Trace0.0 percentage of eyes
Week 1Epithelial Edema - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
Week 1Epithelial Edema - Fanfilcon A Lens (Test)None100.0 percentage of eyes
Week 1Epithelial Edema - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
Week 2Epithelial Edema - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
Week 2Epithelial Edema - Fanfilcon A Lens (Test)Trace0.9 percentage of eyes
Week 2Epithelial Edema - Fanfilcon A Lens (Test)None99.1 percentage of eyes
Week 2Epithelial Edema - Fanfilcon A Lens (Test)Mild0.0 percentage of eyes
Week 2Epithelial Edema - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
Month 1Epithelial Edema - Fanfilcon A Lens (Test)Mild0.0 percentage of eyes
Month 1Epithelial Edema - Fanfilcon A Lens (Test)None100.0 percentage of eyes
Month 1Epithelial Edema - Fanfilcon A Lens (Test)Trace0.0 percentage of eyes
Month 1Epithelial Edema - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
Month 1Epithelial Edema - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
Month 2Epithelial Edema - Fanfilcon A Lens (Test)None100.0 percentage of eyes
Month 2Epithelial Edema - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
Month 2Epithelial Edema - Fanfilcon A Lens (Test)Mild0.0 percentage of eyes
Month 2Epithelial Edema - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
Month 2Epithelial Edema - Fanfilcon A Lens (Test)Trace0.0 percentage of eyes
Month 3Epithelial Edema - Fanfilcon A Lens (Test)None100.0 percentage of eyes
Month 3Epithelial Edema - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
Month 3Epithelial Edema - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
Month 3Epithelial Edema - Fanfilcon A Lens (Test)Trace0.0 percentage of eyes
Month 3Epithelial Edema - Fanfilcon A Lens (Test)Mild0.0 percentage of eyes
UnscheduledEpithelial Edema - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
UnscheduledEpithelial Edema - Fanfilcon A Lens (Test)Trace0.0 percentage of eyes
UnscheduledEpithelial Edema - Fanfilcon A Lens (Test)Mild0.0 percentage of eyes
UnscheduledEpithelial Edema - Fanfilcon A Lens (Test)None100.0 percentage of eyes
UnscheduledEpithelial Edema - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
Primary

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.

ArmMeasureGroupValue (NUMBER)
BaselineLimbal Hyperemia - Enfilcon A Lens (Control)Mild0.0 percentage of eyes
BaselineLimbal Hyperemia - Enfilcon A Lens (Control)None79.3 percentage of eyes
BaselineLimbal Hyperemia - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
BaselineLimbal Hyperemia - Enfilcon A Lens (Control)Trace20.7 percentage of eyes
BaselineLimbal Hyperemia - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
Week 1Limbal Hyperemia - Enfilcon A Lens (Control)Mild0.0 percentage of eyes
Week 1Limbal Hyperemia - Enfilcon A Lens (Control)Trace19.2 percentage of eyes
Week 1Limbal Hyperemia - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
Week 1Limbal Hyperemia - Enfilcon A Lens (Control)None80.8 percentage of eyes
Week 1Limbal Hyperemia - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
Week 2Limbal Hyperemia - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
Week 2Limbal Hyperemia - Enfilcon A Lens (Control)Trace6.9 percentage of eyes
Week 2Limbal Hyperemia - Enfilcon A Lens (Control)None93.1 percentage of eyes
Week 2Limbal Hyperemia - Enfilcon A Lens (Control)Mild0.0 percentage of eyes
Week 2Limbal Hyperemia - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
Month 1Limbal Hyperemia - Enfilcon A Lens (Control)Mild0.0 percentage of eyes
Month 1Limbal Hyperemia - Enfilcon A Lens (Control)None93.1 percentage of eyes
Month 1Limbal Hyperemia - Enfilcon A Lens (Control)Trace6.9 percentage of eyes
Month 1Limbal Hyperemia - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
Month 1Limbal Hyperemia - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
Month 2Limbal Hyperemia - Enfilcon A Lens (Control)None92.9 percentage of eyes
Month 2Limbal Hyperemia - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
Month 2Limbal Hyperemia - Enfilcon A Lens (Control)Mild0.0 percentage of eyes
Month 2Limbal Hyperemia - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
Month 2Limbal Hyperemia - Enfilcon A Lens (Control)Trace7.1 percentage of eyes
Month 3Limbal Hyperemia - Enfilcon A Lens (Control)None87.9 percentage of eyes
Month 3Limbal Hyperemia - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
Month 3Limbal Hyperemia - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
Month 3Limbal Hyperemia - Enfilcon A Lens (Control)Trace10.3 percentage of eyes
Month 3Limbal Hyperemia - Enfilcon A Lens (Control)Mild1.7 percentage of eyes
UnscheduledLimbal Hyperemia - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
UnscheduledLimbal Hyperemia - Enfilcon A Lens (Control)Trace0.0 percentage of eyes
UnscheduledLimbal Hyperemia - Enfilcon A Lens (Control)Mild0.0 percentage of eyes
UnscheduledLimbal Hyperemia - Enfilcon A Lens (Control)None100.0 percentage of eyes
UnscheduledLimbal Hyperemia - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
Primary

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.

ArmMeasureGroupValue (NUMBER)
BaselineLimbal Hyperemia - Fanfilcon A Lens (Test)Mild0.0 percentage of eyes
BaselineLimbal Hyperemia - Fanfilcon A Lens (Test)None80.6 percentage of eyes
BaselineLimbal Hyperemia - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
BaselineLimbal Hyperemia - Fanfilcon A Lens (Test)Trace19.4 percentage of eyes
BaselineLimbal Hyperemia - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
Week 1Limbal Hyperemia - Fanfilcon A Lens (Test)Mild0.0 percentage of eyes
Week 1Limbal Hyperemia - Fanfilcon A Lens (Test)Trace11.1 percentage of eyes
Week 1Limbal Hyperemia - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
Week 1Limbal Hyperemia - Fanfilcon A Lens (Test)None88.9 percentage of eyes
Week 1Limbal Hyperemia - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
Week 2Limbal Hyperemia - Fanfilcon A Lens (Test)Severe0 percentage of eyes
Week 2Limbal Hyperemia - Fanfilcon A Lens (Test)Trace23.6 percentage of eyes
Week 2Limbal Hyperemia - Fanfilcon A Lens (Test)None76.4 percentage of eyes
Week 2Limbal Hyperemia - Fanfilcon A Lens (Test)Mild0.0 percentage of eyes
Week 2Limbal Hyperemia - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
Month 1Limbal Hyperemia - Fanfilcon A Lens (Test)Mild0.0 percentage of eyes
Month 1Limbal Hyperemia - Fanfilcon A Lens (Test)None80.6 percentage of eyes
Month 1Limbal Hyperemia - Fanfilcon A Lens (Test)Trace19.4 percentage of eyes
Month 1Limbal Hyperemia - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
Month 1Limbal Hyperemia - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
Month 2Limbal Hyperemia - Fanfilcon A Lens (Test)None82.4 percentage of eyes
Month 2Limbal Hyperemia - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
Month 2Limbal Hyperemia - Fanfilcon A Lens (Test)Mild0.0 percentage of eyes
Month 2Limbal Hyperemia - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
Month 2Limbal Hyperemia - Fanfilcon A Lens (Test)Trace17.6 percentage of eyes
Month 3Limbal Hyperemia - Fanfilcon A Lens (Test)None75.9 percentage of eyes
Month 3Limbal Hyperemia - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
Month 3Limbal Hyperemia - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
Month 3Limbal Hyperemia - Fanfilcon A Lens (Test)Trace23.1 percentage of eyes
Month 3Limbal Hyperemia - Fanfilcon A Lens (Test)Mild0.9 percentage of eyes
UnscheduledLimbal Hyperemia - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
UnscheduledLimbal Hyperemia - Fanfilcon A Lens (Test)Trace0.0 percentage of eyes
UnscheduledLimbal Hyperemia - Fanfilcon A Lens (Test)Mild0.0 percentage of eyes
UnscheduledLimbal Hyperemia - Fanfilcon A Lens (Test)None100.0 percentage of eyes
UnscheduledLimbal Hyperemia - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
Primary

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.

ArmMeasureGroupValue (NUMBER)
BaselinePalpebral Conjunctiva - Enfilcon A Lens (Control)Absent55.2 percentage of eyes
BaselinePalpebral Conjunctiva - Enfilcon A Lens (Control)Present44.8 percentage of eyes
Week 1Palpebral Conjunctiva - Enfilcon A Lens (Control)Absent69.2 percentage of eyes
Week 1Palpebral Conjunctiva - Enfilcon A Lens (Control)Present30.8 percentage of eyes
Week 2Palpebral Conjunctiva - Enfilcon A Lens (Control)Absent62.1 percentage of eyes
Week 2Palpebral Conjunctiva - Enfilcon A Lens (Control)Present37.9 percentage of eyes
Month 1Palpebral Conjunctiva - Enfilcon A Lens (Control)Absent58.6 percentage of eyes
Month 1Palpebral Conjunctiva - Enfilcon A Lens (Control)Present41.4 percentage of eyes
Month 2Palpebral Conjunctiva - Enfilcon A Lens (Control)Absent67.9 percentage of eyes
Month 2Palpebral Conjunctiva - Enfilcon A Lens (Control)Present32.1 percentage of eyes
Month 3Palpebral Conjunctiva - Enfilcon A Lens (Control)Absent67.2 percentage of eyes
Month 3Palpebral Conjunctiva - Enfilcon A Lens (Control)Present32.8 percentage of eyes
UnscheduledPalpebral Conjunctiva - Enfilcon A Lens (Control)Absent66.7 percentage of eyes
UnscheduledPalpebral Conjunctiva - Enfilcon A Lens (Control)Present33.3 percentage of eyes
Primary

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.

ArmMeasureGroupValue (NUMBER)
BaselinePalpebral Conjunctiva - Fanfilcon A Lens (Test)Absent69.4 percentage of eyes
BaselinePalpebral Conjunctiva - Fanfilcon A Lens (Test)Present30.6 percentage of eyes
Week 1Palpebral Conjunctiva - Fanfilcon A Lens (Test)Absent64.8 percentage of eyes
Week 1Palpebral Conjunctiva - Fanfilcon A Lens (Test)Present35.2 percentage of eyes
Week 2Palpebral Conjunctiva - Fanfilcon A Lens (Test)Absent63.2 percentage of eyes
Week 2Palpebral Conjunctiva - Fanfilcon A Lens (Test)Present36.8 percentage of eyes
Month 1Palpebral Conjunctiva - Fanfilcon A Lens (Test)Absent67.6 percentage of eyes
Month 1Palpebral Conjunctiva - Fanfilcon A Lens (Test)Present32.4 percentage of eyes
Month 2Palpebral Conjunctiva - Fanfilcon A Lens (Test)Absent60.2 percentage of eyes
Month 2Palpebral Conjunctiva - Fanfilcon A Lens (Test)Present39.8 percentage of eyes
Month 3Palpebral Conjunctiva - Fanfilcon A Lens (Test)Absent58.3 percentage of eyes
Month 3Palpebral Conjunctiva - Fanfilcon A Lens (Test)Present41.7 percentage of eyes
UnscheduledPalpebral Conjunctiva - Fanfilcon A Lens (Test)Absent50.0 percentage of eyes
UnscheduledPalpebral Conjunctiva - Fanfilcon A Lens (Test)Present50.0 percentage of eyes
Primary

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.

ArmMeasureGroupValue (NUMBER)
BaselineStromal Edema - Enfilcon A Lens (Control)Mild0.0 percentage of eyes
BaselineStromal Edema - Enfilcon A Lens (Control)None100.0 percentage of eyes
BaselineStromal Edema - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
BaselineStromal Edema - Enfilcon A Lens (Control)Trace0.0 percentage of eyes
BaselineStromal Edema - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
Week 1Stromal Edema - Enfilcon A Lens (Control)Mild0.0 percentage of eyes
Week 1Stromal Edema - Enfilcon A Lens (Control)Trace0.0 percentage of eyes
Week 1Stromal Edema - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
Week 1Stromal Edema - Enfilcon A Lens (Control)None100.0 percentage of eyes
Week 1Stromal Edema - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
Week 2Stromal Edema - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
Week 2Stromal Edema - Enfilcon A Lens (Control)Trace0.0 percentage of eyes
Week 2Stromal Edema - Enfilcon A Lens (Control)None100.0 percentage of eyes
Week 2Stromal Edema - Enfilcon A Lens (Control)Mild0.0 percentage of eyes
Week 2Stromal Edema - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
Month 1Stromal Edema - Enfilcon A Lens (Control)Mild0.0 percentage of eyes
Month 1Stromal Edema - Enfilcon A Lens (Control)None100.0 percentage of eyes
Month 1Stromal Edema - Enfilcon A Lens (Control)Trace0.0 percentage of eyes
Month 1Stromal Edema - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
Month 1Stromal Edema - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
Month 2Stromal Edema - Enfilcon A Lens (Control)None100.0 percentage of eyes
Month 2Stromal Edema - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
Month 2Stromal Edema - Enfilcon A Lens (Control)Mild0.0 percentage of eyes
Month 2Stromal Edema - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
Month 2Stromal Edema - Enfilcon A Lens (Control)Trace0.0 percentage of eyes
Month 3Stromal Edema - Enfilcon A Lens (Control)None100.0 percentage of eyes
Month 3Stromal Edema - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
Month 3Stromal Edema - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
Month 3Stromal Edema - Enfilcon A Lens (Control)Trace0.0 percentage of eyes
Month 3Stromal Edema - Enfilcon A Lens (Control)Mild0.0 percentage of eyes
UnscheduledStromal Edema - Enfilcon A Lens (Control)Moderate0.0 percentage of eyes
UnscheduledStromal Edema - Enfilcon A Lens (Control)Trace0.0 percentage of eyes
UnscheduledStromal Edema - Enfilcon A Lens (Control)Mild0.0 percentage of eyes
UnscheduledStromal Edema - Enfilcon A Lens (Control)None100.0 percentage of eyes
UnscheduledStromal Edema - Enfilcon A Lens (Control)Severe0.0 percentage of eyes
Primary

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.

ArmMeasureGroupValue (NUMBER)
BaselineStromal Edema - Fanfilcon A Lens (Test)Mild0.0 percentage of eyes
BaselineStromal Edema - Fanfilcon A Lens (Test)None100.0 percentage of eyes
BaselineStromal Edema - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
BaselineStromal Edema - Fanfilcon A Lens (Test)Trace0.0 percentage of eyes
BaselineStromal Edema - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
Week 1Stromal Edema - Fanfilcon A Lens (Test)Mild0.0 percentage of eyes
Week 1Stromal Edema - Fanfilcon A Lens (Test)Trace0.0 percentage of eyes
Week 1Stromal Edema - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
Week 1Stromal Edema - Fanfilcon A Lens (Test)None100.0 percentage of eyes
Week 1Stromal Edema - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
Week 2Stromal Edema - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
Week 2Stromal Edema - Fanfilcon A Lens (Test)Trace0.9 percentage of eyes
Week 2Stromal Edema - Fanfilcon A Lens (Test)None99.1 percentage of eyes
Week 2Stromal Edema - Fanfilcon A Lens (Test)Mild0.0 percentage of eyes
Week 2Stromal Edema - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
Month 1Stromal Edema - Fanfilcon A Lens (Test)Mild0.0 percentage of eyes
Month 1Stromal Edema - Fanfilcon A Lens (Test)None100.0 percentage of eyes
Month 1Stromal Edema - Fanfilcon A Lens (Test)Trace0.0 percentage of eyes
Month 1Stromal Edema - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
Month 1Stromal Edema - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
Month 2Stromal Edema - Fanfilcon A Lens (Test)None100.0 percentage of eyes
Month 2Stromal Edema - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
Month 2Stromal Edema - Fanfilcon A Lens (Test)Mild0.0 percentage of eyes
Month 2Stromal Edema - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
Month 2Stromal Edema - Fanfilcon A Lens (Test)Trace0.0 percentage of eyes
Month 3Stromal Edema - Fanfilcon A Lens (Test)None100.0 percentage of eyes
Month 3Stromal Edema - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
Month 3Stromal Edema - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
Month 3Stromal Edema - Fanfilcon A Lens (Test)Trace0.0 percentage of eyes
Month 3Stromal Edema - Fanfilcon A Lens (Test)Mild0.0 percentage of eyes
UnscheduledStromal Edema - Fanfilcon A Lens (Test)Moderate0.0 percentage of eyes
UnscheduledStromal Edema - Fanfilcon A Lens (Test)Trace0.0 percentage of eyes
UnscheduledStromal Edema - Fanfilcon A Lens (Test)Mild0.0 percentage of eyes
UnscheduledStromal Edema - Fanfilcon A Lens (Test)None100.0 percentage of eyes
UnscheduledStromal Edema - Fanfilcon A Lens (Test)Severe0.0 percentage of eyes
Primary

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.

ArmMeasureGroupValue (NUMBER)
BaselineVisual Acuity - Enfilcon A Lens (Control)20/1514 eyes
BaselineVisual Acuity - Enfilcon A Lens (Control)20/600 eyes
BaselineVisual Acuity - Enfilcon A Lens (Control)20/500 eyes
BaselineVisual Acuity - Enfilcon A Lens (Control)20/252 eyes
BaselineVisual Acuity - Enfilcon A Lens (Control)20/2036 eyes
BaselineVisual Acuity - Enfilcon A Lens (Control)20/300 eyes
BaselineVisual Acuity - Enfilcon A Lens (Control)20/400 eyes
Week 1Visual Acuity - Enfilcon A Lens (Control)20/400 eyes
Week 1Visual Acuity - Enfilcon A Lens (Control)20/300 eyes
Week 1Visual Acuity - Enfilcon A Lens (Control)20/2042 eyes
Week 1Visual Acuity - Enfilcon A Lens (Control)20/1514 eyes
Week 1Visual Acuity - Enfilcon A Lens (Control)20/500 eyes
Week 1Visual Acuity - Enfilcon A Lens (Control)20/252 eyes
Week 1Visual Acuity - Enfilcon A Lens (Control)20/600 eyes
Week 2Visual Acuity - Enfilcon A Lens (Control)20/300 eyes
Week 2Visual Acuity - Enfilcon A Lens (Control)20/1514 eyes
Week 2Visual Acuity - Enfilcon A Lens (Control)20/2042 eyes
Week 2Visual Acuity - Enfilcon A Lens (Control)20/252 eyes
Week 2Visual Acuity - Enfilcon A Lens (Control)20/400 eyes
Week 2Visual Acuity - Enfilcon A Lens (Control)20/500 eyes
Week 2Visual Acuity - Enfilcon A Lens (Control)20/600 eyes
Month 1Visual Acuity - Enfilcon A Lens (Control)20/252 eyes
Month 1Visual Acuity - Enfilcon A Lens (Control)20/400 eyes
Month 1Visual Acuity - Enfilcon A Lens (Control)20/2040 eyes
Month 1Visual Acuity - Enfilcon A Lens (Control)20/600 eyes
Month 1Visual Acuity - Enfilcon A Lens (Control)20/500 eyes
Month 1Visual Acuity - Enfilcon A Lens (Control)20/1514 eyes
Month 1Visual Acuity - Enfilcon A Lens (Control)20/300 eyes
Month 2Visual Acuity - Enfilcon A Lens (Control)20/252 eyes
Month 2Visual Acuity - Enfilcon A Lens (Control)20/600 eyes
Month 2Visual Acuity - Enfilcon A Lens (Control)20/500 eyes
Month 2Visual Acuity - Enfilcon A Lens (Control)20/400 eyes
Month 2Visual Acuity - Enfilcon A Lens (Control)20/2042 eyes
Month 2Visual Acuity - Enfilcon A Lens (Control)20/1514 eyes
Month 2Visual Acuity - Enfilcon A Lens (Control)20/300 eyes
Primary

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.

ArmMeasureGroupValue (NUMBER)
BaselineVisual Acuity - Fanfilcon A Lens (Test)20/1527 eyes
BaselineVisual Acuity - Fanfilcon A Lens (Test)20/600 eyes
BaselineVisual Acuity - Fanfilcon A Lens (Test)20/500 eyes
BaselineVisual Acuity - Fanfilcon A Lens (Test)20/253 eyes
BaselineVisual Acuity - Fanfilcon A Lens (Test)20/2078 eyes
BaselineVisual Acuity - Fanfilcon A Lens (Test)20/300 eyes
BaselineVisual Acuity - Fanfilcon A Lens (Test)20/400 eyes
Week 1Visual Acuity - Fanfilcon A Lens (Test)20/400 eyes
Week 1Visual Acuity - Fanfilcon A Lens (Test)20/300 eyes
Week 1Visual Acuity - Fanfilcon A Lens (Test)20/2077 eyes
Week 1Visual Acuity - Fanfilcon A Lens (Test)20/1526 eyes
Week 1Visual Acuity - Fanfilcon A Lens (Test)20/500 eyes
Week 1Visual Acuity - Fanfilcon A Lens (Test)20/253 eyes
Week 1Visual Acuity - Fanfilcon A Lens (Test)20/600 eyes
Week 2Visual Acuity - Fanfilcon A Lens (Test)20/300 eyes
Week 2Visual Acuity - Fanfilcon A Lens (Test)20/1527 eyes
Week 2Visual Acuity - Fanfilcon A Lens (Test)20/2078 eyes
Week 2Visual Acuity - Fanfilcon A Lens (Test)20/253 eyes
Week 2Visual Acuity - Fanfilcon A Lens (Test)20/400 eyes
Week 2Visual Acuity - Fanfilcon A Lens (Test)20/500 eyes
Week 2Visual Acuity - Fanfilcon A Lens (Test)20/600 eyes
Month 1Visual Acuity - Fanfilcon A Lens (Test)20/253 eyes
Month 1Visual Acuity - Fanfilcon A Lens (Test)20/400 eyes
Month 1Visual Acuity - Fanfilcon A Lens (Test)20/2078 eyes
Month 1Visual Acuity - Fanfilcon A Lens (Test)20/600 eyes
Month 1Visual Acuity - Fanfilcon A Lens (Test)20/500 eyes
Month 1Visual Acuity - Fanfilcon A Lens (Test)20/1527 eyes
Month 1Visual Acuity - Fanfilcon A Lens (Test)20/300 eyes
Month 2Visual Acuity - Fanfilcon A Lens (Test)20/253 eyes
Month 2Visual Acuity - Fanfilcon A Lens (Test)20/600 eyes
Month 2Visual Acuity - Fanfilcon A Lens (Test)20/500 eyes
Month 2Visual Acuity - Fanfilcon A Lens (Test)20/400 eyes
Month 2Visual Acuity - Fanfilcon A Lens (Test)20/2078 eyes
Month 2Visual Acuity - Fanfilcon A Lens (Test)20/1527 eyes
Month 2Visual Acuity - Fanfilcon A Lens (Test)20/300 eyes
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_UNITS)
BaselineComfort - Enfilcon A Lens (Control)OC - very uncomfortable0 eyes
BaselineComfort - Enfilcon A Lens (Control)CUI - comfortable6 eyes
BaselineComfort - Enfilcon A Lens (Control)CDD - comfortable12 eyes
BaselineComfort - Enfilcon A Lens (Control)EDC - very uncomfortable6 eyes
BaselineComfort - Enfilcon A Lens (Control)CV - very comfortable16 eyes
BaselineComfort - Enfilcon A Lens (Control)CUI - causes pain0 eyes
BaselineComfort - Enfilcon A Lens (Control)OC - very comfortable24 eyes
BaselineComfort - Enfilcon A Lens (Control)CUI - excellent20 eyes
BaselineComfort - Enfilcon A Lens (Control)CV - causes pain0 eyes
BaselineComfort - Enfilcon A Lens (Control)CDD - very comfortable18 eyes
BaselineComfort - Enfilcon A Lens (Control)EDC - causes pain0 eyes
BaselineComfort - Enfilcon A Lens (Control)CV - excellent22 eyes
BaselineComfort - Enfilcon A Lens (Control)CDD - excellent26 eyes
BaselineComfort - Enfilcon A Lens (Control)EDC - slightly uncomfortable10 eyes
BaselineComfort - Enfilcon A Lens (Control)OC - causes pain0 eyes
BaselineComfort - Enfilcon A Lens (Control)CUI - very comfortable26 eyes
BaselineComfort - Enfilcon A Lens (Control)CDD - causes pain0 eyes
BaselineComfort - Enfilcon A Lens (Control)CV - very uncomfortable0 eyes
BaselineComfort - Enfilcon A Lens (Control)OC- comfortable10 eyes
BaselineComfort - Enfilcon A Lens (Control)EDC - very comfortable12 eyes
BaselineComfort - Enfilcon A Lens (Control)CV - slightly uncomfortable8 eyes
BaselineComfort - Enfilcon A Lens (Control)CUI- slightly uncomfortable6 eyes
BaselineComfort - Enfilcon A Lens (Control)EDC - comfortable14 eyes
BaselineComfort - Enfilcon A Lens (Control)CDD-very uncomfortable0 eyes
BaselineComfort - Enfilcon A Lens (Control)OC - slightly uncomfortable4 eyes
BaselineComfort - Enfilcon A Lens (Control)CDD - slightly uncomfortable2 eyes
BaselineComfort - Enfilcon A Lens (Control)OC - excellent20 eyes
BaselineComfort - Enfilcon A Lens (Control)CV - comfortable12 eyes
BaselineComfort - Enfilcon A Lens (Control)CUI - very uncomfortable0 eyes
BaselineComfort - Enfilcon A Lens (Control)EDC - excellent16 eyes
Week 1Comfort - Enfilcon A Lens (Control)CDD - causes pain0 eyes
Week 1Comfort - Enfilcon A Lens (Control)EDC - very comfortable14 eyes
Week 1Comfort - Enfilcon A Lens (Control)EDC - very uncomfortable2 eyes
Week 1Comfort - Enfilcon A Lens (Control)EDC - comfortable10 eyes
Week 1Comfort - Enfilcon A Lens (Control)CUI - comfortable6 eyes
Week 1Comfort - Enfilcon A Lens (Control)EDC - slightly uncomfortable14 eyes
Week 1Comfort - Enfilcon A Lens (Control)CUI - excellent16 eyes
Week 1Comfort - Enfilcon A Lens (Control)CV - slightly uncomfortable2 eyes
Week 1Comfort - Enfilcon A Lens (Control)CUI- slightly uncomfortable7 eyes
Week 1Comfort - Enfilcon A Lens (Control)CV - comfortable8 eyes
Week 1Comfort - Enfilcon A Lens (Control)CUI - very uncomfortable0 eyes
Week 1Comfort - Enfilcon A Lens (Control)CV - causes pain0 eyes
Week 1Comfort - Enfilcon A Lens (Control)CV - very comfortable14 eyes
Week 1Comfort - Enfilcon A Lens (Control)CUI - causes pain0 eyes
Week 1Comfort - Enfilcon A Lens (Control)CV - excellent28 eyes
Week 1Comfort - Enfilcon A Lens (Control)CDD - excellent22 eyes
Week 1Comfort - Enfilcon A Lens (Control)OC - causes pain0 eyes
Week 1Comfort - Enfilcon A Lens (Control)CDD - very comfortable15 eyes
Week 1Comfort - Enfilcon A Lens (Control)CUI - very comfortable23 eyes
Week 1Comfort - Enfilcon A Lens (Control)OC - very uncomfortable0 eyes
Week 1Comfort - Enfilcon A Lens (Control)CDD - comfortable12 eyes
Week 1Comfort - Enfilcon A Lens (Control)OC - slightly uncomfortable10 eyes
Week 1Comfort - Enfilcon A Lens (Control)CDD - slightly uncomfortable3 eyes
Week 1Comfort - Enfilcon A Lens (Control)OC- comfortable10 eyes
Week 1Comfort - Enfilcon A Lens (Control)CDD-very uncomfortable0 eyes
Week 1Comfort - Enfilcon A Lens (Control)OC - very comfortable16 eyes
Week 1Comfort - Enfilcon A Lens (Control)EDC - causes pain0 eyes
Week 1Comfort - Enfilcon A Lens (Control)CV - very uncomfortable0 eyes
Week 1Comfort - Enfilcon A Lens (Control)OC - excellent16 eyes
Week 1Comfort - Enfilcon A Lens (Control)EDC - excellent12 eyes
Week 2Comfort - Enfilcon A Lens (Control)CUI - very uncomfortable0 eyes
Week 2Comfort - Enfilcon A Lens (Control)OC - slightly uncomfortable3 eyes
Week 2Comfort - Enfilcon A Lens (Control)EDC - slightly uncomfortable7 eyes
Week 2Comfort - Enfilcon A Lens (Control)CV - comfortable16 eyes
Week 2Comfort - Enfilcon A Lens (Control)OC - excellent20 eyes
Week 2Comfort - Enfilcon A Lens (Control)CDD - slightly uncomfortable2 eyes
Week 2Comfort - Enfilcon A Lens (Control)CUI - excellent30 eyes
Week 2Comfort - Enfilcon A Lens (Control)CV - causes pain0 eyes
Week 2Comfort - Enfilcon A Lens (Control)OC- comfortable16 eyes
Week 2Comfort - Enfilcon A Lens (Control)EDC - very comfortable5 eyes
Week 2Comfort - Enfilcon A Lens (Control)CUI- slightly uncomfortable0 eyes
Week 2Comfort - Enfilcon A Lens (Control)EDC - comfortable24 eyes
Week 2Comfort - Enfilcon A Lens (Control)CDD-very uncomfortable0 eyes
Week 2Comfort - Enfilcon A Lens (Control)CV - very uncomfortable0 eyes
Week 2Comfort - Enfilcon A Lens (Control)CV - slightly uncomfortable2 eyes
Week 2Comfort - Enfilcon A Lens (Control)OC - very comfortable19 eyes
Week 2Comfort - Enfilcon A Lens (Control)OC - causes pain0 eyes
Week 2Comfort - Enfilcon A Lens (Control)EDC - causes pain0 eyes
Week 2Comfort - Enfilcon A Lens (Control)CDD - excellent24 eyes
Week 2Comfort - Enfilcon A Lens (Control)CV - excellent32 eyes
Week 2Comfort - Enfilcon A Lens (Control)CUI - comfortable12 eyes
Week 2Comfort - Enfilcon A Lens (Control)CDD - very comfortable13 eyes
Week 2Comfort - Enfilcon A Lens (Control)EDC - excellent22 eyes
Week 2Comfort - Enfilcon A Lens (Control)CUI - causes pain0 eyes
Week 2Comfort - Enfilcon A Lens (Control)OC - very uncomfortable0 eyes
Week 2Comfort - Enfilcon A Lens (Control)CDD - causes pain0 eyes
Week 2Comfort - Enfilcon A Lens (Control)CV - very comfortable8 eyes
Week 2Comfort - Enfilcon A Lens (Control)EDC - very uncomfortable0 eyes
Week 2Comfort - Enfilcon A Lens (Control)CDD - comfortable19 eyes
Week 2Comfort - Enfilcon A Lens (Control)CUI - very comfortable16 eyes
Month 1Comfort - Enfilcon A Lens (Control)OC - very uncomfortable0 eyes
Month 1Comfort - Enfilcon A Lens (Control)CUI - excellent20 eyes
Month 1Comfort - Enfilcon A Lens (Control)CUI - very comfortable24 eyes
Month 1Comfort - Enfilcon A Lens (Control)CUI - comfortable11 eyes
Month 1Comfort - Enfilcon A Lens (Control)CUI- slightly uncomfortable3 eyes
Month 1Comfort - Enfilcon A Lens (Control)CUI - very uncomfortable0 eyes
Month 1Comfort - Enfilcon A Lens (Control)CUI - causes pain0 eyes
Month 1Comfort - Enfilcon A Lens (Control)CDD - excellent18 eyes
Month 1Comfort - Enfilcon A Lens (Control)CDD - very comfortable10 eyes
Month 1Comfort - Enfilcon A Lens (Control)CDD - comfortable20 eyes
Month 1Comfort - Enfilcon A Lens (Control)CDD - slightly uncomfortable10 eyes
Month 1Comfort - Enfilcon A Lens (Control)CDD-very uncomfortable0 eyes
Month 1Comfort - Enfilcon A Lens (Control)CDD - causes pain0 eyes
Month 1Comfort - Enfilcon A Lens (Control)EDC - excellent14 eyes
Month 1Comfort - Enfilcon A Lens (Control)EDC - very comfortable8 eyes
Month 1Comfort - Enfilcon A Lens (Control)EDC - comfortable20 eyes
Month 1Comfort - Enfilcon A Lens (Control)EDC - slightly uncomfortable12 eyes
Month 1Comfort - Enfilcon A Lens (Control)EDC - very uncomfortable4 eyes
Month 1Comfort - Enfilcon A Lens (Control)EDC - causes pain0 eyes
Month 1Comfort - Enfilcon A Lens (Control)OC - excellent18 eyes
Month 1Comfort - Enfilcon A Lens (Control)OC - very comfortable12 eyes
Month 1Comfort - Enfilcon A Lens (Control)OC- comfortable22 eyes
Month 1Comfort - Enfilcon A Lens (Control)OC - slightly uncomfortable6 eyes
Month 1Comfort - Enfilcon A Lens (Control)OC - causes pain0 eyes
Month 1Comfort - Enfilcon A Lens (Control)CV - excellent26 eyes
Month 1Comfort - Enfilcon A Lens (Control)CV - very comfortable16 eyes
Month 1Comfort - Enfilcon A Lens (Control)CV - comfortable14 eyes
Month 1Comfort - Enfilcon A Lens (Control)CV - slightly uncomfortable2 eyes
Month 1Comfort - Enfilcon A Lens (Control)CV - very uncomfortable0 eyes
Month 1Comfort - Enfilcon A Lens (Control)CV - causes pain0 eyes
Month 2Comfort - Enfilcon A Lens (Control)CUI- slightly uncomfortable4 eyes
Month 2Comfort - Enfilcon A Lens (Control)OC - slightly uncomfortable6 eyes
Month 2Comfort - Enfilcon A Lens (Control)EDC - comfortable15 eyes
Month 2Comfort - Enfilcon A Lens (Control)CV - very comfortable8 eyes
Month 2Comfort - Enfilcon A Lens (Control)CDD - comfortable13 eyes
Month 2Comfort - Enfilcon A Lens (Control)CUI - excellent28 eyes
Month 2Comfort - Enfilcon A Lens (Control)CDD - causes pain0 eyes
Month 2Comfort - Enfilcon A Lens (Control)CDD - very comfortable17 eyes
Month 2Comfort - Enfilcon A Lens (Control)OC - very uncomfortable0 eyes
Month 2Comfort - Enfilcon A Lens (Control)EDC - slightly uncomfortable8 eyes
Month 2Comfort - Enfilcon A Lens (Control)CUI - very uncomfortable0 eyes
Month 2Comfort - Enfilcon A Lens (Control)CV - excellent32 eyes
Month 2Comfort - Enfilcon A Lens (Control)EDC - excellent16 eyes
Month 2Comfort - Enfilcon A Lens (Control)CDD - excellent22 eyes
Month 2Comfort - Enfilcon A Lens (Control)CUI - causes pain0 eyes
Month 2Comfort - Enfilcon A Lens (Control)OC - causes pain0 eyes
Month 2Comfort - Enfilcon A Lens (Control)CV - very uncomfortable0 eyes
Month 2Comfort - Enfilcon A Lens (Control)OC - very comfortable12 eyes
Month 2Comfort - Enfilcon A Lens (Control)EDC - very uncomfortable2 eyes
Month 2Comfort - Enfilcon A Lens (Control)CV - slightly uncomfortable4 eyes
Month 2Comfort - Enfilcon A Lens (Control)CDD-very uncomfortable0 eyes
Month 2Comfort - Enfilcon A Lens (Control)CV - causes pain0 eyes
Month 2Comfort - Enfilcon A Lens (Control)EDC - causes pain0 eyes
Month 2Comfort - Enfilcon A Lens (Control)CUI - very comfortable12 eyes
Month 2Comfort - Enfilcon A Lens (Control)OC- comfortable14 eyes
Month 2Comfort - Enfilcon A Lens (Control)OC - excellent24 eyes
Month 2Comfort - Enfilcon A Lens (Control)CUI - comfortable12 eyes
Month 2Comfort - Enfilcon A Lens (Control)CDD - slightly uncomfortable4 eyes
Month 2Comfort - Enfilcon A Lens (Control)CV - comfortable12 eyes
Month 2Comfort - Enfilcon A Lens (Control)EDC - very comfortable15 eyes
Month 3Comfort - Enfilcon A Lens (Control)CV - comfortable11 eyes
Month 3Comfort - Enfilcon A Lens (Control)EDC - excellent14 eyes
Month 3Comfort - Enfilcon A Lens (Control)EDC - causes pain0 eyes
Month 3Comfort - Enfilcon A Lens (Control)CDD - causes pain0 eyes
Month 3Comfort - Enfilcon A Lens (Control)CV - causes pain0 eyes
Month 3Comfort - Enfilcon A Lens (Control)OC - excellent18 eyes
Month 3Comfort - Enfilcon A Lens (Control)CDD-very uncomfortable2 eyes
Month 3Comfort - Enfilcon A Lens (Control)OC - very comfortable16 eyes
Month 3Comfort - Enfilcon A Lens (Control)CDD - slightly uncomfortable9 eyes
Month 3Comfort - Enfilcon A Lens (Control)CV - very uncomfortable0 eyes
Month 3Comfort - Enfilcon A Lens (Control)OC- comfortable16 eyes
Month 3Comfort - Enfilcon A Lens (Control)CDD - comfortable10 eyes
Month 3Comfort - Enfilcon A Lens (Control)OC - slightly uncomfortable6 eyes
Month 3Comfort - Enfilcon A Lens (Control)CDD - very comfortable18 eyes
Month 3Comfort - Enfilcon A Lens (Control)OC - very uncomfortable2 eyes
Month 3Comfort - Enfilcon A Lens (Control)CDD - excellent19 eyes
Month 3Comfort - Enfilcon A Lens (Control)OC - causes pain0 eyes
Month 3Comfort - Enfilcon A Lens (Control)CUI - causes pain0 eyes
Month 3Comfort - Enfilcon A Lens (Control)CUI - excellent26 eyes
Month 3Comfort - Enfilcon A Lens (Control)CV - excellent22 eyes
Month 3Comfort - Enfilcon A Lens (Control)CUI - very uncomfortable0 eyes
Month 3Comfort - Enfilcon A Lens (Control)CV - very comfortable22 eyes
Month 3Comfort - Enfilcon A Lens (Control)CUI- slightly uncomfortable2 eyes
Month 3Comfort - Enfilcon A Lens (Control)CUI - comfortable12 eyes
Month 3Comfort - Enfilcon A Lens (Control)CV - slightly uncomfortable3 eyes
Month 3Comfort - Enfilcon A Lens (Control)EDC - comfortable10 eyes
Month 3Comfort - Enfilcon A Lens (Control)EDC - slightly uncomfortable19 eyes
Month 3Comfort - Enfilcon A Lens (Control)EDC - very comfortable12 eyes
Month 3Comfort - Enfilcon A Lens (Control)CUI - very comfortable18 eyes
Month 3Comfort - Enfilcon A Lens (Control)EDC - very uncomfortable3 eyes
UnscheduledComfort - Enfilcon A Lens (Control)EDC - slightly uncomfortable0 eyes
UnscheduledComfort - Enfilcon A Lens (Control)CV - very comfortable0 eyes
UnscheduledComfort - Enfilcon A Lens (Control)CUI- slightly uncomfortable0 eyes
UnscheduledComfort - Enfilcon A Lens (Control)OC - excellent4 eyes
UnscheduledComfort - Enfilcon A Lens (Control)CV - very uncomfortable0 eyes
UnscheduledComfort - Enfilcon A Lens (Control)CV - causes pain0 eyes
UnscheduledComfort - Enfilcon A Lens (Control)CDD - comfortable0 eyes
UnscheduledComfort - Enfilcon A Lens (Control)EDC - excellent6 eyes
UnscheduledComfort - Enfilcon A Lens (Control)CV - comfortable2 eyes
UnscheduledComfort - Enfilcon A Lens (Control)CUI - comfortable0 eyes
UnscheduledComfort - Enfilcon A Lens (Control)EDC - very comfortable0 eyes
UnscheduledComfort - Enfilcon A Lens (Control)OC- comfortable0 eyes
UnscheduledComfort - Enfilcon A Lens (Control)CDD - slightly uncomfortable0 eyes
UnscheduledComfort - Enfilcon A Lens (Control)OC - very comfortable2 eyes
UnscheduledComfort - Enfilcon A Lens (Control)EDC - causes pain0 eyes
UnscheduledComfort - Enfilcon A Lens (Control)CV - slightly uncomfortable0 eyes
UnscheduledComfort - Enfilcon A Lens (Control)EDC - comfortable0 eyes
UnscheduledComfort - Enfilcon A Lens (Control)OC - causes pain0 eyes
UnscheduledComfort - Enfilcon A Lens (Control)CUI - causes pain0 eyes
UnscheduledComfort - Enfilcon A Lens (Control)EDC - very uncomfortable0 eyes
UnscheduledComfort - Enfilcon A Lens (Control)CUI - excellent6 eyes
UnscheduledComfort - Enfilcon A Lens (Control)CUI - very comfortable0 eyes
UnscheduledComfort - Enfilcon A Lens (Control)CDD - excellent6 eyes
UnscheduledComfort - Enfilcon A Lens (Control)CDD-very uncomfortable0 eyes
UnscheduledComfort - Enfilcon A Lens (Control)CV - excellent4 eyes
UnscheduledComfort - Enfilcon A Lens (Control)CUI - very uncomfortable0 eyes
UnscheduledComfort - Enfilcon A Lens (Control)CDD - causes pain0 eyes
UnscheduledComfort - Enfilcon A Lens (Control)OC - very uncomfortable0 eyes
UnscheduledComfort - Enfilcon A Lens (Control)CDD - very comfortable0 eyes
UnscheduledComfort - Enfilcon A Lens (Control)OC - slightly uncomfortable0 eyes
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_UNITS)
BaselineComfort - Fanfilcon A Lens (Test)OC - very uncomfortable0 Eyes
BaselineComfort - Fanfilcon A Lens (Test)CUI - comfortable15 Eyes
BaselineComfort - Fanfilcon A Lens (Test)CDD - comfortable19 Eyes
BaselineComfort - Fanfilcon A Lens (Test)EDC - very uncomfortable2 Eyes
BaselineComfort - Fanfilcon A Lens (Test)CV - very comfortable22 Eyes
BaselineComfort - Fanfilcon A Lens (Test)CUI - causes pain0 Eyes
BaselineComfort - Fanfilcon A Lens (Test)OC - very comfortable47 Eyes
BaselineComfort - Fanfilcon A Lens (Test)CUI - excellent50 Eyes
BaselineComfort - Fanfilcon A Lens (Test)CV - causes pain0 Eyes
BaselineComfort - Fanfilcon A Lens (Test)CDD - very comfortable38 Eyes
BaselineComfort - Fanfilcon A Lens (Test)EDC - causes pain0 Eyes
BaselineComfort - Fanfilcon A Lens (Test)CV - excellent60 Eyes
BaselineComfort - Fanfilcon A Lens (Test)CDD - excellent45 Eyes
BaselineComfort - Fanfilcon A Lens (Test)EDC - slightly uncomfortable19 Eyes
BaselineComfort - Fanfilcon A Lens (Test)OC - causes pain0 Eyes
BaselineComfort - Fanfilcon A Lens (Test)CUI - very comfortable40 Eyes
BaselineComfort - Fanfilcon A Lens (Test)CDD - causes pain0 Eyes
BaselineComfort - Fanfilcon A Lens (Test)CV - very uncomfortable2 Eyes
BaselineComfort - Fanfilcon A Lens (Test)OC - comfortable20 Eyes
BaselineComfort - Fanfilcon A Lens (Test)EDC - very comfortable46 Eyes
BaselineComfort - Fanfilcon A Lens (Test)CV - slightly uncomfortable7 Eyes
BaselineComfort - Fanfilcon A Lens (Test)CUI- slightly uncomfortable3 Eyes
BaselineComfort - Fanfilcon A Lens (Test)EDC - comfortable27 Eyes
BaselineComfort - Fanfilcon A Lens (Test)CDD-very uncomfortable0 Eyes
BaselineComfort - Fanfilcon A Lens (Test)OC - slightly uncomfortable4 Eyes
BaselineComfort - Fanfilcon A Lens (Test)CDD - slightly uncomfortable6 Eyes
BaselineComfort - Fanfilcon A Lens (Test)OC - excellent37 Eyes
BaselineComfort - Fanfilcon A Lens (Test)CV - comfortable17 Eyes
BaselineComfort - Fanfilcon A Lens (Test)CUI - very uncomfortable0 Eyes
BaselineComfort - Fanfilcon A Lens (Test)EDC - excellent14 Eyes
Week 1Comfort - Fanfilcon A Lens (Test)CDD - causes pain0 Eyes
Week 1Comfort - Fanfilcon A Lens (Test)EDC - very comfortable34 Eyes
Week 1Comfort - Fanfilcon A Lens (Test)EDC - very uncomfortable2 Eyes
Week 1Comfort - Fanfilcon A Lens (Test)EDC - comfortable32 Eyes
Week 1Comfort - Fanfilcon A Lens (Test)CUI - comfortable6 Eyes
Week 1Comfort - Fanfilcon A Lens (Test)EDC - slightly uncomfortable8 Eyes
Week 1Comfort - Fanfilcon A Lens (Test)CUI - excellent50 Eyes
Week 1Comfort - Fanfilcon A Lens (Test)CV - slightly uncomfortable0 Eyes
Week 1Comfort - Fanfilcon A Lens (Test)CUI- slightly uncomfortable2 Eyes
Week 1Comfort - Fanfilcon A Lens (Test)CV - comfortable12 Eyes
Week 1Comfort - Fanfilcon A Lens (Test)CUI - very uncomfortable0 Eyes
Week 1Comfort - Fanfilcon A Lens (Test)CV - causes pain0 Eyes
Week 1Comfort - Fanfilcon A Lens (Test)CV - very comfortable36 Eyes
Week 1Comfort - Fanfilcon A Lens (Test)CUI - causes pain0 Eyes
Week 1Comfort - Fanfilcon A Lens (Test)CV - excellent60 Eyes
Week 1Comfort - Fanfilcon A Lens (Test)CDD - excellent45 Eyes
Week 1Comfort - Fanfilcon A Lens (Test)OC - causes pain0 Eyes
Week 1Comfort - Fanfilcon A Lens (Test)CDD - very comfortable50 Eyes
Week 1Comfort - Fanfilcon A Lens (Test)CUI - very comfortable50 Eyes
Week 1Comfort - Fanfilcon A Lens (Test)OC - very uncomfortable0 Eyes
Week 1Comfort - Fanfilcon A Lens (Test)CDD - comfortable13 Eyes
Week 1Comfort - Fanfilcon A Lens (Test)OC - slightly uncomfortable2 Eyes
Week 1Comfort - Fanfilcon A Lens (Test)CDD - slightly uncomfortable0 Eyes
Week 1Comfort - Fanfilcon A Lens (Test)OC - comfortable8 Eyes
Week 1Comfort - Fanfilcon A Lens (Test)CDD-very uncomfortable0 Eyes
Week 1Comfort - Fanfilcon A Lens (Test)OC - very comfortable58 Eyes
Week 1Comfort - Fanfilcon A Lens (Test)EDC - causes pain0 Eyes
Week 1Comfort - Fanfilcon A Lens (Test)CV - very uncomfortable0 Eyes
Week 1Comfort - Fanfilcon A Lens (Test)OC - excellent40 Eyes
Week 1Comfort - Fanfilcon A Lens (Test)EDC - excellent32 Eyes
Week 2Comfort - Fanfilcon A Lens (Test)CUI - very uncomfortable0 Eyes
Week 2Comfort - Fanfilcon A Lens (Test)OC - slightly uncomfortable0 Eyes
Week 2Comfort - Fanfilcon A Lens (Test)EDC - slightly uncomfortable2 Eyes
Week 2Comfort - Fanfilcon A Lens (Test)CV - comfortable11 Eyes
Week 2Comfort - Fanfilcon A Lens (Test)OC - excellent40 Eyes
Week 2Comfort - Fanfilcon A Lens (Test)CDD - slightly uncomfortable0 Eyes
Week 2Comfort - Fanfilcon A Lens (Test)CUI - excellent67 Eyes
Week 2Comfort - Fanfilcon A Lens (Test)CV - causes pain0 Eyes
Week 2Comfort - Fanfilcon A Lens (Test)OC - comfortable10 Eyes
Week 2Comfort - Fanfilcon A Lens (Test)EDC - very comfortable43 Eyes
Week 2Comfort - Fanfilcon A Lens (Test)CUI- slightly uncomfortable4 Eyes
Week 2Comfort - Fanfilcon A Lens (Test)EDC - comfortable30 Eyes
Week 2Comfort - Fanfilcon A Lens (Test)CDD-very uncomfortable2 Eyes
Week 2Comfort - Fanfilcon A Lens (Test)CV - very uncomfortable2 Eyes
Week 2Comfort - Fanfilcon A Lens (Test)CV - slightly uncomfortable0 Eyes
Week 2Comfort - Fanfilcon A Lens (Test)OC - very comfortable54 Eyes
Week 2Comfort - Fanfilcon A Lens (Test)OC - causes pain0 Eyes
Week 2Comfort - Fanfilcon A Lens (Test)EDC - causes pain0 Eyes
Week 2Comfort - Fanfilcon A Lens (Test)CDD - excellent48 Eyes
Week 2Comfort - Fanfilcon A Lens (Test)CV - excellent63 Eyes
Week 2Comfort - Fanfilcon A Lens (Test)CUI - comfortable6 Eyes
Week 2Comfort - Fanfilcon A Lens (Test)CDD - very comfortable47 Eyes
Week 2Comfort - Fanfilcon A Lens (Test)EDC - excellent31 Eyes
Week 2Comfort - Fanfilcon A Lens (Test)CUI - causes pain0 Eyes
Week 2Comfort - Fanfilcon A Lens (Test)OC - very uncomfortable2 Eyes
Week 2Comfort - Fanfilcon A Lens (Test)CDD - causes pain0 Eyes
Week 2Comfort - Fanfilcon A Lens (Test)CV - very comfortable30 Eyes
Week 2Comfort - Fanfilcon A Lens (Test)EDC - very uncomfortable0 Eyes
Week 2Comfort - Fanfilcon A Lens (Test)CDD - comfortable9 Eyes
Week 2Comfort - Fanfilcon A Lens (Test)CUI - very comfortable29 Eyes
Month 1Comfort - Fanfilcon A Lens (Test)OC - very uncomfortable0 Eyes
Month 1Comfort - Fanfilcon A Lens (Test)CUI - excellent61 Eyes
Month 1Comfort - Fanfilcon A Lens (Test)CUI - very comfortable36 Eyes
Month 1Comfort - Fanfilcon A Lens (Test)CUI - comfortable10 Eyes
Month 1Comfort - Fanfilcon A Lens (Test)CUI- slightly uncomfortable1 Eyes
Month 1Comfort - Fanfilcon A Lens (Test)CUI - very uncomfortable0 Eyes
Month 1Comfort - Fanfilcon A Lens (Test)CUI - causes pain0 Eyes
Month 1Comfort - Fanfilcon A Lens (Test)CDD - excellent50 Eyes
Month 1Comfort - Fanfilcon A Lens (Test)CDD - very comfortable40 Eyes
Month 1Comfort - Fanfilcon A Lens (Test)CDD - comfortable9 Eyes
Month 1Comfort - Fanfilcon A Lens (Test)CDD - slightly uncomfortable9 Eyes
Month 1Comfort - Fanfilcon A Lens (Test)CDD-very uncomfortable0 Eyes
Month 1Comfort - Fanfilcon A Lens (Test)CDD - causes pain0 Eyes
Month 1Comfort - Fanfilcon A Lens (Test)EDC - excellent30 Eyes
Month 1Comfort - Fanfilcon A Lens (Test)EDC - very comfortable38 Eyes
Month 1Comfort - Fanfilcon A Lens (Test)EDC - comfortable22 Eyes
Month 1Comfort - Fanfilcon A Lens (Test)EDC - slightly uncomfortable16 Eyes
Month 1Comfort - Fanfilcon A Lens (Test)EDC - very uncomfortable2 Eyes
Month 1Comfort - Fanfilcon A Lens (Test)EDC - causes pain0 Eyes
Month 1Comfort - Fanfilcon A Lens (Test)OC - excellent43 Eyes
Month 1Comfort - Fanfilcon A Lens (Test)OC - very comfortable44 Eyes
Month 1Comfort - Fanfilcon A Lens (Test)OC - comfortable14 Eyes
Month 1Comfort - Fanfilcon A Lens (Test)OC - slightly uncomfortable7 Eyes
Month 1Comfort - Fanfilcon A Lens (Test)OC - causes pain0 Eyes
Month 1Comfort - Fanfilcon A Lens (Test)CV - excellent56 Eyes
Month 1Comfort - Fanfilcon A Lens (Test)CV - very comfortable38 Eyes
Month 1Comfort - Fanfilcon A Lens (Test)CV - comfortable6 Eyes
Month 1Comfort - Fanfilcon A Lens (Test)CV - slightly uncomfortable6 Eyes
Month 1Comfort - Fanfilcon A Lens (Test)CV - very uncomfortable2 Eyes
Month 1Comfort - Fanfilcon A Lens (Test)CV - causes pain0 Eyes
Month 2Comfort - Fanfilcon A Lens (Test)CUI- slightly uncomfortable2 Eyes
Month 2Comfort - Fanfilcon A Lens (Test)OC - slightly uncomfortable6 Eyes
Month 2Comfort - Fanfilcon A Lens (Test)EDC - comfortable25 Eyes
Month 2Comfort - Fanfilcon A Lens (Test)CV - very comfortable36 Eyes
Month 2Comfort - Fanfilcon A Lens (Test)CDD - comfortable8 Eyes
Month 2Comfort - Fanfilcon A Lens (Test)CUI - excellent60 Eyes
Month 2Comfort - Fanfilcon A Lens (Test)CDD - causes pain0 Eyes
Month 2Comfort - Fanfilcon A Lens (Test)CDD - very comfortable48 Eyes
Month 2Comfort - Fanfilcon A Lens (Test)OC - very uncomfortable0 Eyes
Month 2Comfort - Fanfilcon A Lens (Test)EDC - slightly uncomfortable11 Eyes
Month 2Comfort - Fanfilcon A Lens (Test)CUI - very uncomfortable0 Eyes
Month 2Comfort - Fanfilcon A Lens (Test)CV - excellent56 Eyes
Month 2Comfort - Fanfilcon A Lens (Test)EDC - excellent36 Eyes
Month 2Comfort - Fanfilcon A Lens (Test)CDD - excellent48 Eyes
Month 2Comfort - Fanfilcon A Lens (Test)CUI - causes pain0 Eyes
Month 2Comfort - Fanfilcon A Lens (Test)OC - causes pain0 Eyes
Month 2Comfort - Fanfilcon A Lens (Test)CV - very uncomfortable0 Eyes
Month 2Comfort - Fanfilcon A Lens (Test)OC - very comfortable42 Eyes
Month 2Comfort - Fanfilcon A Lens (Test)EDC - very uncomfortable4 Eyes
Month 2Comfort - Fanfilcon A Lens (Test)CV - slightly uncomfortable4 Eyes
Month 2Comfort - Fanfilcon A Lens (Test)CDD-very uncomfortable0 Eyes
Month 2Comfort - Fanfilcon A Lens (Test)CV - causes pain0 Eyes
Month 2Comfort - Fanfilcon A Lens (Test)EDC - causes pain0 Eyes
Month 2Comfort - Fanfilcon A Lens (Test)CUI - very comfortable40 Eyes
Month 2Comfort - Fanfilcon A Lens (Test)OC - comfortable14 Eyes
Month 2Comfort - Fanfilcon A Lens (Test)OC - excellent46 Eyes
Month 2Comfort - Fanfilcon A Lens (Test)CUI - comfortable6 Eyes
Month 2Comfort - Fanfilcon A Lens (Test)CDD - slightly uncomfortable4 Eyes
Month 2Comfort - Fanfilcon A Lens (Test)CV - comfortable12 Eyes
Month 2Comfort - Fanfilcon A Lens (Test)EDC - very comfortable32 Eyes
Month 3Comfort - Fanfilcon A Lens (Test)CV - comfortable8 Eyes
Month 3Comfort - Fanfilcon A Lens (Test)EDC - excellent30 Eyes
Month 3Comfort - Fanfilcon A Lens (Test)EDC - causes pain0 Eyes
Month 3Comfort - Fanfilcon A Lens (Test)CDD - causes pain0 Eyes
Month 3Comfort - Fanfilcon A Lens (Test)CV - causes pain0 Eyes
Month 3Comfort - Fanfilcon A Lens (Test)OC - excellent46 Eyes
Month 3Comfort - Fanfilcon A Lens (Test)CDD-very uncomfortable0 Eyes
Month 3Comfort - Fanfilcon A Lens (Test)OC - very comfortable48 Eyes
Month 3Comfort - Fanfilcon A Lens (Test)CDD - slightly uncomfortable4 Eyes
Month 3Comfort - Fanfilcon A Lens (Test)CV - very uncomfortable0 Eyes
Month 3Comfort - Fanfilcon A Lens (Test)OC - comfortable8 Eyes
Month 3Comfort - Fanfilcon A Lens (Test)CDD - comfortable6 Eyes
Month 3Comfort - Fanfilcon A Lens (Test)OC - slightly uncomfortable6 Eyes
Month 3Comfort - Fanfilcon A Lens (Test)CDD - very comfortable50 Eyes
Month 3Comfort - Fanfilcon A Lens (Test)OC - very uncomfortable0 Eyes
Month 3Comfort - Fanfilcon A Lens (Test)CDD - excellent48 Eyes
Month 3Comfort - Fanfilcon A Lens (Test)OC - causes pain0 Eyes
Month 3Comfort - Fanfilcon A Lens (Test)CUI - causes pain0 Eyes
Month 3Comfort - Fanfilcon A Lens (Test)CUI - excellent64 Eyes
Month 3Comfort - Fanfilcon A Lens (Test)CV - excellent62 Eyes
Month 3Comfort - Fanfilcon A Lens (Test)CUI - very uncomfortable0 Eyes
Month 3Comfort - Fanfilcon A Lens (Test)CV - very comfortable34 Eyes
Month 3Comfort - Fanfilcon A Lens (Test)CUI- slightly uncomfortable2 Eyes
Month 3Comfort - Fanfilcon A Lens (Test)CUI - comfortable2 Eyes
Month 3Comfort - Fanfilcon A Lens (Test)CV - slightly uncomfortable4 Eyes
Month 3Comfort - Fanfilcon A Lens (Test)EDC - comfortable24 Eyes
Month 3Comfort - Fanfilcon A Lens (Test)EDC - slightly uncomfortable8 Eyes
Month 3Comfort - Fanfilcon A Lens (Test)EDC - very comfortable44 Eyes
Month 3Comfort - Fanfilcon A Lens (Test)CUI - very comfortable40 Eyes
Month 3Comfort - Fanfilcon A Lens (Test)EDC - very uncomfortable2 Eyes
UnscheduledComfort - Fanfilcon A Lens (Test)EDC - slightly uncomfortable0 Eyes
UnscheduledComfort - Fanfilcon A Lens (Test)CV - very comfortable2 Eyes
UnscheduledComfort - Fanfilcon A Lens (Test)CUI- slightly uncomfortable0 Eyes
UnscheduledComfort - Fanfilcon A Lens (Test)OC - excellent2 Eyes
UnscheduledComfort - Fanfilcon A Lens (Test)CV - very uncomfortable0 Eyes
UnscheduledComfort - Fanfilcon A Lens (Test)CV - causes pain0 Eyes
UnscheduledComfort - Fanfilcon A Lens (Test)CDD - comfortable0 Eyes
UnscheduledComfort - Fanfilcon A Lens (Test)EDC - excellent2 Eyes
UnscheduledComfort - Fanfilcon A Lens (Test)CV - comfortable0 Eyes
UnscheduledComfort - Fanfilcon A Lens (Test)CUI - comfortable0 Eyes
UnscheduledComfort - Fanfilcon A Lens (Test)EDC - very comfortable2 Eyes
UnscheduledComfort - Fanfilcon A Lens (Test)OC - comfortable0 Eyes
UnscheduledComfort - Fanfilcon A Lens (Test)CDD - slightly uncomfortable0 Eyes
UnscheduledComfort - Fanfilcon A Lens (Test)OC - very comfortable2 Eyes
UnscheduledComfort - Fanfilcon A Lens (Test)EDC - causes pain0 Eyes
UnscheduledComfort - Fanfilcon A Lens (Test)CV - slightly uncomfortable0 Eyes
UnscheduledComfort - Fanfilcon A Lens (Test)EDC - comfortable0 Eyes
UnscheduledComfort - Fanfilcon A Lens (Test)OC - causes pain0 Eyes
UnscheduledComfort - Fanfilcon A Lens (Test)CUI - causes pain0 Eyes
UnscheduledComfort - Fanfilcon A Lens (Test)EDC - very uncomfortable0 Eyes
UnscheduledComfort - Fanfilcon A Lens (Test)CUI - excellent4 Eyes
UnscheduledComfort - Fanfilcon A Lens (Test)CUI - very comfortable0 Eyes
UnscheduledComfort - Fanfilcon A Lens (Test)CDD - excellent2 Eyes
UnscheduledComfort - Fanfilcon A Lens (Test)CDD-very uncomfortable0 Eyes
UnscheduledComfort - Fanfilcon A Lens (Test)CV - excellent2 Eyes
UnscheduledComfort - Fanfilcon A Lens (Test)CUI - very uncomfortable0 Eyes
UnscheduledComfort - Fanfilcon A Lens (Test)CDD - causes pain0 Eyes
UnscheduledComfort - Fanfilcon A Lens (Test)OC - very uncomfortable0 Eyes
UnscheduledComfort - Fanfilcon A Lens (Test)CDD - very comfortable2 Eyes
UnscheduledComfort - Fanfilcon A Lens (Test)OC - slightly uncomfortable0 Eyes
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_UNITS)
BaselineEase of Insertion and Removal - Enfilcon A Lens (Control)EOR - very good12 Eyes
BaselineEase of Insertion and Removal - Enfilcon A Lens (Control)EOR - unmanageable0 Eyes
BaselineEase of Insertion and Removal - Enfilcon A Lens (Control)EOR - good6 Eyes
BaselineEase of Insertion and Removal - Enfilcon A Lens (Control)EOI - good10 Eyes
BaselineEase of Insertion and Removal - Enfilcon A Lens (Control)EOI - very good12 Eyes
BaselineEase of Insertion and Removal - Enfilcon A Lens (Control)EOI - unmanageable0 Eyes
BaselineEase of Insertion and Removal - Enfilcon A Lens (Control)EOR - excellent40 Eyes
BaselineEase of Insertion and Removal - Enfilcon A Lens (Control)EOI - excellent34 Eyes
BaselineEase of Insertion and Removal - Enfilcon A Lens (Control)EOR - poor0 Eyes
BaselineEase of Insertion and Removal - Enfilcon A Lens (Control)EOR - very poor0 Eyes
BaselineEase of Insertion and Removal - Enfilcon A Lens (Control)EOI - poor2 Eyes
BaselineEase of Insertion and Removal - Enfilcon A Lens (Control)EOI - very poor0 Eyes
Week 1Ease of Insertion and Removal - Enfilcon A Lens (Control)EOI - poor2 Eyes
Week 1Ease of Insertion and Removal - Enfilcon A Lens (Control)EOI - unmanageable0 Eyes
Week 1Ease of Insertion and Removal - Enfilcon A Lens (Control)EOR - unmanageable1 Eyes
Week 1Ease of Insertion and Removal - Enfilcon A Lens (Control)EOI - very poor0 Eyes
Week 1Ease of Insertion and Removal - Enfilcon A Lens (Control)EOI - very good14 Eyes
Week 1Ease of Insertion and Removal - Enfilcon A Lens (Control)EOR - very good12 Eyes
Week 1Ease of Insertion and Removal - Enfilcon A Lens (Control)EOI - excellent31 Eyes
Week 1Ease of Insertion and Removal - Enfilcon A Lens (Control)EOR - excellent36 Eyes
Week 1Ease of Insertion and Removal - Enfilcon A Lens (Control)EOI - good5 Eyes
Week 1Ease of Insertion and Removal - Enfilcon A Lens (Control)EOR - very poor0 Eyes
Week 1Ease of Insertion and Removal - Enfilcon A Lens (Control)EOR - poor1 Eyes
Week 1Ease of Insertion and Removal - Enfilcon A Lens (Control)EOR - good2 Eyes
Week 2Ease of Insertion and Removal - Enfilcon A Lens (Control)EOR - good5 Eyes
Week 2Ease of Insertion and Removal - Enfilcon A Lens (Control)EOR - poor1 Eyes
Week 2Ease of Insertion and Removal - Enfilcon A Lens (Control)EOI - very good12 Eyes
Week 2Ease of Insertion and Removal - Enfilcon A Lens (Control)EOI - good10 Eyes
Week 2Ease of Insertion and Removal - Enfilcon A Lens (Control)EOI - excellent36 Eyes
Week 2Ease of Insertion and Removal - Enfilcon A Lens (Control)EOR - unmanageable0 Eyes
Week 2Ease of Insertion and Removal - Enfilcon A Lens (Control)EOI - poor0 Eyes
Week 2Ease of Insertion and Removal - Enfilcon A Lens (Control)EOI - very poor0 Eyes
Week 2Ease of Insertion and Removal - Enfilcon A Lens (Control)EOI - unmanageable0 Eyes
Week 2Ease of Insertion and Removal - Enfilcon A Lens (Control)EOR - excellent40 Eyes
Week 2Ease of Insertion and Removal - Enfilcon A Lens (Control)EOR - very good12 Eyes
Week 2Ease of Insertion and Removal - Enfilcon A Lens (Control)EOR - very poor0 Eyes
Month 1Ease of Insertion and Removal - Enfilcon A Lens (Control)EOR - good8 Eyes
Month 1Ease of Insertion and Removal - Enfilcon A Lens (Control)EOR - very poor0 Eyes
Month 1Ease of Insertion and Removal - Enfilcon A Lens (Control)EOI - unmanageable0 Eyes
Month 1Ease of Insertion and Removal - Enfilcon A Lens (Control)EOI - very good16 Eyes
Month 1Ease of Insertion and Removal - Enfilcon A Lens (Control)EOI - good10 Eyes
Month 1Ease of Insertion and Removal - Enfilcon A Lens (Control)EOR - very good16 Eyes
Month 1Ease of Insertion and Removal - Enfilcon A Lens (Control)EOR - unmanageable0 Eyes
Month 1Ease of Insertion and Removal - Enfilcon A Lens (Control)EOR - poor0 Eyes
Month 1Ease of Insertion and Removal - Enfilcon A Lens (Control)EOI - very poor0 Eyes
Month 1Ease of Insertion and Removal - Enfilcon A Lens (Control)EOR - excellent34 Eyes
Month 1Ease of Insertion and Removal - Enfilcon A Lens (Control)EOI - poor2 Eyes
Month 1Ease of Insertion and Removal - Enfilcon A Lens (Control)EOI - excellent30 Eyes
Month 2Ease of Insertion and Removal - Enfilcon A Lens (Control)EOR - unmanageable0 Eyes
Month 2Ease of Insertion and Removal - Enfilcon A Lens (Control)EOI - unmanageable0 Eyes
Month 2Ease of Insertion and Removal - Enfilcon A Lens (Control)EOI - good6 Eyes
Month 2Ease of Insertion and Removal - Enfilcon A Lens (Control)EOR - very poor0 Eyes
Month 2Ease of Insertion and Removal - Enfilcon A Lens (Control)EOR - excellent36 Eyes
Month 2Ease of Insertion and Removal - Enfilcon A Lens (Control)EOI - poor4 Eyes
Month 2Ease of Insertion and Removal - Enfilcon A Lens (Control)EOI - very good10 Eyes
Month 2Ease of Insertion and Removal - Enfilcon A Lens (Control)EOR - good4 Eyes
Month 2Ease of Insertion and Removal - Enfilcon A Lens (Control)EOR - very good16 Eyes
Month 2Ease of Insertion and Removal - Enfilcon A Lens (Control)EOR - poor0 Eyes
Month 2Ease of Insertion and Removal - Enfilcon A Lens (Control)EOI - very poor0 Eyes
Month 2Ease of Insertion and Removal - Enfilcon A Lens (Control)EOI - excellent36 Eyes
Month 3Ease of Insertion and Removal - Enfilcon A Lens (Control)EOR - unmanageable0 Eyes
Month 3Ease of Insertion and Removal - Enfilcon A Lens (Control)EOI - excellent30 Eyes
Month 3Ease of Insertion and Removal - Enfilcon A Lens (Control)EOI - very good17 Eyes
Month 3Ease of Insertion and Removal - Enfilcon A Lens (Control)EOI - good7 Eyes
Month 3Ease of Insertion and Removal - Enfilcon A Lens (Control)EOI - poor4 Eyes
Month 3Ease of Insertion and Removal - Enfilcon A Lens (Control)EOI - very poor0 Eyes
Month 3Ease of Insertion and Removal - Enfilcon A Lens (Control)EOI - unmanageable0 Eyes
Month 3Ease of Insertion and Removal - Enfilcon A Lens (Control)EOR - excellent34 Eyes
Month 3Ease of Insertion and Removal - Enfilcon A Lens (Control)EOR - very good14 Eyes
Month 3Ease of Insertion and Removal - Enfilcon A Lens (Control)EOR - good10 Eyes
Month 3Ease of Insertion and Removal - Enfilcon A Lens (Control)EOR - poor0 Eyes
Month 3Ease of Insertion and Removal - Enfilcon A Lens (Control)EOR - very poor0 Eyes
UnscheduledEase of Insertion and Removal - Enfilcon A Lens (Control)EOR - good0 Eyes
UnscheduledEase of Insertion and Removal - Enfilcon A Lens (Control)EOR - very good0 Eyes
UnscheduledEase of Insertion and Removal - Enfilcon A Lens (Control)EOR - excellent6 Eyes
UnscheduledEase of Insertion and Removal - Enfilcon A Lens (Control)EOI - unmanageable0 Eyes
UnscheduledEase of Insertion and Removal - Enfilcon A Lens (Control)EOR - unmanageable0 Eyes
UnscheduledEase of Insertion and Removal - Enfilcon A Lens (Control)EOR - very poor0 Eyes
UnscheduledEase of Insertion and Removal - Enfilcon A Lens (Control)EOI - very poor0 Eyes
UnscheduledEase of Insertion and Removal - Enfilcon A Lens (Control)EOI - poor0 Eyes
UnscheduledEase of Insertion and Removal - Enfilcon A Lens (Control)EOI - good0 Eyes
UnscheduledEase of Insertion and Removal - Enfilcon A Lens (Control)EOI - very good0 Eyes
UnscheduledEase of Insertion and Removal - Enfilcon A Lens (Control)EOI - excellent6 Eyes
UnscheduledEase of Insertion and Removal - Enfilcon A Lens (Control)EOR - poor0 Eyes
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_UNITS)
BaselineEase of Insertion and Removal - Fanfilcon A Lens (Test)EOI - unmanageable0 eyes
BaselineEase of Insertion and Removal - Fanfilcon A Lens (Test)EOR - unmanageable0 eyes
BaselineEase of Insertion and Removal - Fanfilcon A Lens (Test)EOR - very good28 eyes
BaselineEase of Insertion and Removal - Fanfilcon A Lens (Test)EOR - excellent72 eyes
BaselineEase of Insertion and Removal - Fanfilcon A Lens (Test)EOI - very good26 eyes
BaselineEase of Insertion and Removal - Fanfilcon A Lens (Test)EOI - excellent78 eyes
BaselineEase of Insertion and Removal - Fanfilcon A Lens (Test)EOI - good4 eyes
BaselineEase of Insertion and Removal - Fanfilcon A Lens (Test)EOR - very poor0 eyes
BaselineEase of Insertion and Removal - Fanfilcon A Lens (Test)EOI - poor0 eyes
BaselineEase of Insertion and Removal - Fanfilcon A Lens (Test)EOR - poor0 eyes
BaselineEase of Insertion and Removal - Fanfilcon A Lens (Test)EOI - very poor0 eyes
BaselineEase of Insertion and Removal - Fanfilcon A Lens (Test)EOR - good8 eyes
Week 1Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOI - excellent70 eyes
Week 1Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOR - unmanageable0 eyes
Week 1Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOI - good4 eyes
Week 1Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOR - poor4 eyes
Week 1Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOI - unmanageable0 eyes
Week 1Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOR - excellent62 eyes
Week 1Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOR - good11 eyes
Week 1Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOR - very good31 eyes
Week 1Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOI - very good34 eyes
Week 1Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOI - poor0 eyes
Week 1Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOR - very poor0 eyes
Week 1Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOI - very poor0 eyes
Week 2Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOR - unmanageable0 eyes
Week 2Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOI - very poor2 eyes
Week 2Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOI - good2 eyes
Week 2Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOR - poor2 eyes
Week 2Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOI - poor0 eyes
Week 2Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOR - very poor2 eyes
Week 2Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOI - unmanageable0 eyes
Week 2Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOR - very good33 eyes
Week 2Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOR - good12 eyes
Week 2Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOR - excellent57 eyes
Week 2Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOI - very good30 eyes
Week 2Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOI - excellent72 eyes
Month 1Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOR - very poor0 eyes
Month 1Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOI - excellent73 eyes
Month 1Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOI - very good30 eyes
Month 1Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOI - good2 eyes
Month 1Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOI - poor3 eyes
Month 1Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOI - very poor0 eyes
Month 1Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOI - unmanageable0 eyes
Month 1Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOR - excellent48 eyes
Month 1Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOR - very good43 eyes
Month 1Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOR - good15 eyes
Month 1Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOR - poor2 eyes
Month 1Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOR - unmanageable0 eyes
Month 2Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOR - good18 eyes
Month 2Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOI - excellent68 eyes
Month 2Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOI - good6 eyes
Month 2Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOI - poor0 eyes
Month 2Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOR - poor2 eyes
Month 2Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOR - very good30 eyes
Month 2Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOR - excellent58 eyes
Month 2Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOR - very poor0 eyes
Month 2Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOI - very poor0 eyes
Month 2Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOI - very good34 eyes
Month 2Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOI - unmanageable0 eyes
Month 2Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOR - unmanageable0 eyes
Month 3Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOR - excellent56 eyes
Month 3Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOI - very poor0 eyes
Month 3Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOR - very good30 eyes
Month 3Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOI - poor0 eyes
Month 3Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOR - good22 eyes
Month 3Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOI - good4 eyes
Month 3Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOR - unmanageable0 eyes
Month 3Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOR - poor0 eyes
Month 3Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOI - very good32 eyes
Month 3Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOR - very poor0 eyes
Month 3Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOI - excellent72 eyes
Month 3Ease of Insertion and Removal - Fanfilcon A Lens (Test)EOI - unmanageable0 eyes
UnscheduledEase of Insertion and Removal - Fanfilcon A Lens (Test)EOR - excellent2 eyes
UnscheduledEase of Insertion and Removal - Fanfilcon A Lens (Test)EOI - poor0 eyes
UnscheduledEase of Insertion and Removal - Fanfilcon A Lens (Test)EOR - very good2 eyes
UnscheduledEase of Insertion and Removal - Fanfilcon A Lens (Test)EOR - unmanageable0 eyes
UnscheduledEase of Insertion and Removal - Fanfilcon A Lens (Test)EOR - very poor0 eyes
UnscheduledEase of Insertion and Removal - Fanfilcon A Lens (Test)EOI - excellent2 eyes
UnscheduledEase of Insertion and Removal - Fanfilcon A Lens (Test)EOI - very poor0 eyes
UnscheduledEase of Insertion and Removal - Fanfilcon A Lens (Test)EOI - good0 eyes
UnscheduledEase of Insertion and Removal - Fanfilcon A Lens (Test)EOI - unmanageable0 eyes
UnscheduledEase of Insertion and Removal - Fanfilcon A Lens (Test)EOR - poor0 eyes
UnscheduledEase of Insertion and Removal - Fanfilcon A Lens (Test)EOR - good0 eyes
UnscheduledEase of Insertion and Removal - Fanfilcon A Lens (Test)EOI - very good2 eyes
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_UNITS)
BaselineOverall Vision Quality - Enfilcon A Lens (Control)OVC - unacceptable0 eyes
BaselineOverall Vision Quality - Enfilcon A Lens (Control)VAN- unacceptable0 eyes
BaselineOverall Vision Quality - Enfilcon A Lens (Control)VAN - very good26 eyes
BaselineOverall Vision Quality - Enfilcon A Lens (Control)VAN - excellent13 eyes
BaselineOverall Vision Quality - Enfilcon A Lens (Control)OVC - very good24 eyes
BaselineOverall Vision Quality - Enfilcon A Lens (Control)OVC - excellent23 eyes
BaselineOverall Vision Quality - Enfilcon A Lens (Control)OVC - good11 eyes
BaselineOverall Vision Quality - Enfilcon A Lens (Control)VAN - very poor0 eyes
BaselineOverall Vision Quality - Enfilcon A Lens (Control)OVC - poor0 eyes
BaselineOverall Vision Quality - Enfilcon A Lens (Control)VAN - poor0 eyes
BaselineOverall Vision Quality - Enfilcon A Lens (Control)OVC - very poor0 eyes
BaselineOverall Vision Quality - Enfilcon A Lens (Control)VAN - good19 eyes
Week 1Overall Vision Quality - Enfilcon A Lens (Control)OVC - excellent28 eyes
Week 1Overall Vision Quality - Enfilcon A Lens (Control)VAN- unacceptable0 eyes
Week 1Overall Vision Quality - Enfilcon A Lens (Control)OVC - good12 eyes
Week 1Overall Vision Quality - Enfilcon A Lens (Control)VAN - poor2 eyes
Week 1Overall Vision Quality - Enfilcon A Lens (Control)OVC - unacceptable0 eyes
Week 1Overall Vision Quality - Enfilcon A Lens (Control)VAN - excellent26 eyes
Week 1Overall Vision Quality - Enfilcon A Lens (Control)VAN - good12 eyes
Week 1Overall Vision Quality - Enfilcon A Lens (Control)VAN - very good12 eyes
Week 1Overall Vision Quality - Enfilcon A Lens (Control)OVC - very good10 eyes
Week 1Overall Vision Quality - Enfilcon A Lens (Control)OVC - poor2 eyes
Week 1Overall Vision Quality - Enfilcon A Lens (Control)VAN - very poor0 eyes
Week 1Overall Vision Quality - Enfilcon A Lens (Control)OVC - very poor0 eyes
Week 2Overall Vision Quality - Enfilcon A Lens (Control)VAN- unacceptable0 eyes
Week 2Overall Vision Quality - Enfilcon A Lens (Control)OVC - very poor0 eyes
Week 2Overall Vision Quality - Enfilcon A Lens (Control)OVC - good12 eyes
Week 2Overall Vision Quality - Enfilcon A Lens (Control)VAN - poor1 eyes
Week 2Overall Vision Quality - Enfilcon A Lens (Control)OVC - poor1 eyes
Week 2Overall Vision Quality - Enfilcon A Lens (Control)VAN - very poor0 eyes
Week 2Overall Vision Quality - Enfilcon A Lens (Control)OVC - unacceptable0 eyes
Week 2Overall Vision Quality - Enfilcon A Lens (Control)VAN - very good15 eyes
Week 2Overall Vision Quality - Enfilcon A Lens (Control)VAN - good14 eyes
Week 2Overall Vision Quality - Enfilcon A Lens (Control)VAN - excellent28 eyes
Week 2Overall Vision Quality - Enfilcon A Lens (Control)OVC - very good17 eyes
Week 2Overall Vision Quality - Enfilcon A Lens (Control)OVC - excellent28 eyes
Month 1Overall Vision Quality - Enfilcon A Lens (Control)VAN - very poor0 eyes
Month 1Overall Vision Quality - Enfilcon A Lens (Control)OVC - excellent22 eyes
Month 1Overall Vision Quality - Enfilcon A Lens (Control)OVC - very good20 eyes
Month 1Overall Vision Quality - Enfilcon A Lens (Control)OVC - good14 eyes
Month 1Overall Vision Quality - Enfilcon A Lens (Control)OVC - poor2 eyes
Month 1Overall Vision Quality - Enfilcon A Lens (Control)OVC - very poor0 eyes
Month 1Overall Vision Quality - Enfilcon A Lens (Control)OVC - unacceptable0 eyes
Month 1Overall Vision Quality - Enfilcon A Lens (Control)VAN - excellent22 eyes
Month 1Overall Vision Quality - Enfilcon A Lens (Control)VAN - very good18 eyes
Month 1Overall Vision Quality - Enfilcon A Lens (Control)VAN - good14 eyes
Month 1Overall Vision Quality - Enfilcon A Lens (Control)VAN - poor4 eyes
Month 1Overall Vision Quality - Enfilcon A Lens (Control)VAN- unacceptable0 eyes
Month 2Overall Vision Quality - Enfilcon A Lens (Control)VAN - good11 eyes
Month 2Overall Vision Quality - Enfilcon A Lens (Control)OVC - excellent30 eyes
Month 2Overall Vision Quality - Enfilcon A Lens (Control)OVC - good9 eyes
Month 2Overall Vision Quality - Enfilcon A Lens (Control)OVC - poor0 eyes
Month 2Overall Vision Quality - Enfilcon A Lens (Control)VAN - poor2 eyes
Month 2Overall Vision Quality - Enfilcon A Lens (Control)VAN - very good21 eyes
Month 2Overall Vision Quality - Enfilcon A Lens (Control)VAN - excellent20 eyes
Month 2Overall Vision Quality - Enfilcon A Lens (Control)VAN - very poor2 eyes
Month 2Overall Vision Quality - Enfilcon A Lens (Control)OVC - very poor2 eyes
Month 2Overall Vision Quality - Enfilcon A Lens (Control)OVC - very good15 eyes
Month 2Overall Vision Quality - Enfilcon A Lens (Control)OVC - unacceptable0 eyes
Month 2Overall Vision Quality - Enfilcon A Lens (Control)VAN- unacceptable0 eyes
Month 3Overall Vision Quality - Enfilcon A Lens (Control)VAN - excellent20 eyes
Month 3Overall Vision Quality - Enfilcon A Lens (Control)OVC - very poor1 eyes
Month 3Overall Vision Quality - Enfilcon A Lens (Control)VAN - very good16 eyes
Month 3Overall Vision Quality - Enfilcon A Lens (Control)OVC - poor4 eyes
Month 3Overall Vision Quality - Enfilcon A Lens (Control)VAN - good18 eyes
Month 3Overall Vision Quality - Enfilcon A Lens (Control)OVC - good12 eyes
Month 3Overall Vision Quality - Enfilcon A Lens (Control)VAN- unacceptable0 eyes
Month 3Overall Vision Quality - Enfilcon A Lens (Control)VAN - poor4 eyes
Month 3Overall Vision Quality - Enfilcon A Lens (Control)OVC - very good16 eyes
Month 3Overall Vision Quality - Enfilcon A Lens (Control)VAN - very poor0 eyes
Month 3Overall Vision Quality - Enfilcon A Lens (Control)OVC - excellent25 eyes
Month 3Overall Vision Quality - Enfilcon A Lens (Control)OVC - unacceptable0 eyes
UnscheduledOverall Vision Quality - Enfilcon A Lens (Control)VAN - excellent4 eyes
UnscheduledOverall Vision Quality - Enfilcon A Lens (Control)OVC - poor0 eyes
UnscheduledOverall Vision Quality - Enfilcon A Lens (Control)VAN - very good2 eyes
UnscheduledOverall Vision Quality - Enfilcon A Lens (Control)VAN- unacceptable0 eyes
UnscheduledOverall Vision Quality - Enfilcon A Lens (Control)VAN - very poor0 eyes
UnscheduledOverall Vision Quality - Enfilcon A Lens (Control)OVC - excellent4 eyes
UnscheduledOverall Vision Quality - Enfilcon A Lens (Control)OVC - very poor0 eyes
UnscheduledOverall Vision Quality - Enfilcon A Lens (Control)OVC - good2 eyes
UnscheduledOverall Vision Quality - Enfilcon A Lens (Control)OVC - unacceptable0 eyes
UnscheduledOverall Vision Quality - Enfilcon A Lens (Control)VAN - poor0 eyes
UnscheduledOverall Vision Quality - Enfilcon A Lens (Control)VAN - good0 eyes
UnscheduledOverall Vision Quality - Enfilcon A Lens (Control)OVC - very good0 eyes
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_UNITS)
BaselineOverall Vision Quality - Fanfilcon A Lens (Test)OVC - unacceptable0 eyes
BaselineOverall Vision Quality - Fanfilcon A Lens (Test)VAN - unacceptable2 eyes
BaselineOverall Vision Quality - Fanfilcon A Lens (Test)VAN - very good33 eyes
BaselineOverall Vision Quality - Fanfilcon A Lens (Test)VAN - excellent41 eyes
BaselineOverall Vision Quality - Fanfilcon A Lens (Test)OVC - very good41 eyes
BaselineOverall Vision Quality - Fanfilcon A Lens (Test)OVC - excellent53 eyes
BaselineOverall Vision Quality - Fanfilcon A Lens (Test)OVC - good8 eyes
BaselineOverall Vision Quality - Fanfilcon A Lens (Test)VAN - very poor0 eyes
BaselineOverall Vision Quality - Fanfilcon A Lens (Test)OVC - poor6 eyes
BaselineOverall Vision Quality - Fanfilcon A Lens (Test)VAN - poor4 eyes
BaselineOverall Vision Quality - Fanfilcon A Lens (Test)OVC - very poor0 eyes
BaselineOverall Vision Quality - Fanfilcon A Lens (Test)VAN - good28 eyes
Week 1Overall Vision Quality - Fanfilcon A Lens (Test)OVC - excellent70 eyes
Week 1Overall Vision Quality - Fanfilcon A Lens (Test)VAN - unacceptable0 eyes
Week 1Overall Vision Quality - Fanfilcon A Lens (Test)OVC - good8 eyes
Week 1Overall Vision Quality - Fanfilcon A Lens (Test)VAN - poor0 eyes
Week 1Overall Vision Quality - Fanfilcon A Lens (Test)OVC - unacceptable0 eyes
Week 1Overall Vision Quality - Fanfilcon A Lens (Test)VAN - excellent60 eyes
Week 1Overall Vision Quality - Fanfilcon A Lens (Test)VAN - good14 eyes
Week 1Overall Vision Quality - Fanfilcon A Lens (Test)VAN - very good34 eyes
Week 1Overall Vision Quality - Fanfilcon A Lens (Test)OVC - very good30 eyes
Week 1Overall Vision Quality - Fanfilcon A Lens (Test)OVC - poor0 eyes
Week 1Overall Vision Quality - Fanfilcon A Lens (Test)VAN - very poor0 eyes
Week 1Overall Vision Quality - Fanfilcon A Lens (Test)OVC - very poor0 eyes
Week 2Overall Vision Quality - Fanfilcon A Lens (Test)VAN - unacceptable0 eyes
Week 2Overall Vision Quality - Fanfilcon A Lens (Test)OVC - very poor2 eyes
Week 2Overall Vision Quality - Fanfilcon A Lens (Test)OVC - good9 eyes
Week 2Overall Vision Quality - Fanfilcon A Lens (Test)VAN - poor2 eyes
Week 2Overall Vision Quality - Fanfilcon A Lens (Test)OVC - poor0 eyes
Week 2Overall Vision Quality - Fanfilcon A Lens (Test)VAN - very poor0 eyes
Week 2Overall Vision Quality - Fanfilcon A Lens (Test)OVC - unacceptable0 eyes
Week 2Overall Vision Quality - Fanfilcon A Lens (Test)VAN - very good32 eyes
Week 2Overall Vision Quality - Fanfilcon A Lens (Test)VAN - good14 eyes
Week 2Overall Vision Quality - Fanfilcon A Lens (Test)VAN - excellent58 eyes
Week 2Overall Vision Quality - Fanfilcon A Lens (Test)OVC - very good27 eyes
Week 2Overall Vision Quality - Fanfilcon A Lens (Test)OVC - excellent68 eyes
Month 1Overall Vision Quality - Fanfilcon A Lens (Test)VAN - very poor0 eyes
Month 1Overall Vision Quality - Fanfilcon A Lens (Test)OVC - excellent64 eyes
Month 1Overall Vision Quality - Fanfilcon A Lens (Test)OVC - very good28 eyes
Month 1Overall Vision Quality - Fanfilcon A Lens (Test)OVC - good16 eyes
Month 1Overall Vision Quality - Fanfilcon A Lens (Test)OVC - poor0 eyes
Month 1Overall Vision Quality - Fanfilcon A Lens (Test)OVC - very poor0 eyes
Month 1Overall Vision Quality - Fanfilcon A Lens (Test)OVC - unacceptable0 eyes
Month 1Overall Vision Quality - Fanfilcon A Lens (Test)VAN - excellent50 eyes
Month 1Overall Vision Quality - Fanfilcon A Lens (Test)VAN - very good32 eyes
Month 1Overall Vision Quality - Fanfilcon A Lens (Test)VAN - good26 eyes
Month 1Overall Vision Quality - Fanfilcon A Lens (Test)VAN - poor0 eyes
Month 1Overall Vision Quality - Fanfilcon A Lens (Test)VAN - unacceptable0 eyes
Month 2Overall Vision Quality - Fanfilcon A Lens (Test)VAN - good22 eyes
Month 2Overall Vision Quality - Fanfilcon A Lens (Test)OVC - excellent64 eyes
Month 2Overall Vision Quality - Fanfilcon A Lens (Test)OVC - good11 eyes
Month 2Overall Vision Quality - Fanfilcon A Lens (Test)OVC - poor2 eyes
Month 2Overall Vision Quality - Fanfilcon A Lens (Test)VAN - poor0 eyes
Month 2Overall Vision Quality - Fanfilcon A Lens (Test)VAN - very good34 eyes
Month 2Overall Vision Quality - Fanfilcon A Lens (Test)VAN - excellent52 eyes
Month 2Overall Vision Quality - Fanfilcon A Lens (Test)VAN - very poor0 eyes
Month 2Overall Vision Quality - Fanfilcon A Lens (Test)OVC - very poor0 eyes
Month 2Overall Vision Quality - Fanfilcon A Lens (Test)OVC - very good30 eyes
Month 2Overall Vision Quality - Fanfilcon A Lens (Test)OVC - unacceptable1 eyes
Month 2Overall Vision Quality - Fanfilcon A Lens (Test)VAN - unacceptable0 eyes
Month 3Overall Vision Quality - Fanfilcon A Lens (Test)VAN - excellent60 eyes
Month 3Overall Vision Quality - Fanfilcon A Lens (Test)OVC - very poor0 eyes
Month 3Overall Vision Quality - Fanfilcon A Lens (Test)VAN - very good32 eyes
Month 3Overall Vision Quality - Fanfilcon A Lens (Test)OVC - poor2 eyes
Month 3Overall Vision Quality - Fanfilcon A Lens (Test)VAN - good12 eyes
Month 3Overall Vision Quality - Fanfilcon A Lens (Test)OVC - good4 eyes
Month 3Overall Vision Quality - Fanfilcon A Lens (Test)VAN - unacceptable0 eyes
Month 3Overall Vision Quality - Fanfilcon A Lens (Test)VAN - poor4 eyes
Month 3Overall Vision Quality - Fanfilcon A Lens (Test)OVC - very good32 eyes
Month 3Overall Vision Quality - Fanfilcon A Lens (Test)VAN - very poor0 eyes
Month 3Overall Vision Quality - Fanfilcon A Lens (Test)OVC - excellent70 eyes
Month 3Overall Vision Quality - Fanfilcon A Lens (Test)OVC - unacceptable0 eyes
UnscheduledOverall Vision Quality - Fanfilcon A Lens (Test)VAN - excellent4 eyes
UnscheduledOverall Vision Quality - Fanfilcon A Lens (Test)OVC - poor0 eyes
UnscheduledOverall Vision Quality - Fanfilcon A Lens (Test)VAN - very good0 eyes
UnscheduledOverall Vision Quality - Fanfilcon A Lens (Test)VAN - unacceptable0 eyes
UnscheduledOverall Vision Quality - Fanfilcon A Lens (Test)VAN - very poor0 eyes
UnscheduledOverall Vision Quality - Fanfilcon A Lens (Test)OVC - excellent4 eyes
UnscheduledOverall Vision Quality - Fanfilcon A Lens (Test)OVC - very poor0 eyes
UnscheduledOverall Vision Quality - Fanfilcon A Lens (Test)OVC - good0 eyes
UnscheduledOverall Vision Quality - Fanfilcon A Lens (Test)OVC - unacceptable0 eyes
UnscheduledOverall Vision Quality - Fanfilcon A Lens (Test)VAN - poor0 eyes
UnscheduledOverall Vision Quality - Fanfilcon A Lens (Test)VAN - good0 eyes
UnscheduledOverall Vision Quality - Fanfilcon A Lens (Test)OVC - very good0 eyes

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026