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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Myopia

Intervention / Treatment
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* Device: fanfilcon A (test)
* Device: enfilcon A (control)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fanfilcon A (test)<br>Subjects will be randomized to wear fanfilcon A lens (test) for one month of daily wear during the study. | Device: fanfilcon A (test)<br>* silicone hydrogel lens<br>|
| Active Comparator: enfilcon A (control)<br>Subjects will be randomized to wear enfilcon A lens (control) for one month of daily wear during the study. | Device: enfilcon A (control)<br>* silicone hydrogel lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | 
| 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 | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | 
| 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 | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | 
| 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 | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | 
| Corneal Infiltrates - Fanfilcon A Lens (Test) | Corneal infiltrates is assessed for fanfilcon A lens (test). Grading scale: Absent/present | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | 
| Corneal Infiltrates - Enfilcon A Lens (Control) | Corneal infiltrates is assessed for enfilcon A lens (control). Grading scale: absent/present | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | 
| 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 | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | 
| 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 | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | 
| 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; | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | 
| 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; | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | 
| 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 | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | 
| 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 | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | 
| 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 | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | 
| 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 | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | 
| Palpebral Conjunctiva - Fanfilcon A Lens (Test) | Palpebral conjunctiva is assessed for fanfilcon A lens (test). Grading scale: Absent/present | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | 
| Palpebral Conjunctiva - Enfilcon A Lens (Control) | Palpebral conjunctiva is assessed for enfilcon A lens (control). Grading scale: absent/present | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | 
| Visual Acuity - Fanfilcon A Lens (Test) | Visual acuity is assessed for fanfilcon A lens (test) using Snellen chart. | Week 1, Week 2, Month 1, Month 2, Month 3 | 
| Visual Acuity - Enfilcon A Lens (Control) | Visual acuity is assessed for enfilcon A lens (control) using Snellen chart. | Week 1, Week 2, Month 1, Month 2, Month 3 | 
| Average Wearing Time - Fanfilcon A Lens (Test) | Average lens wearing time for fanfilcon A lens (test) measured in hours. | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | 
| Average Wearing Time - Enfilcon A Lens (Control) | Average lens wearing time for enfilcon A lens (control) measured in hours. | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | 
| 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). | Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months follow-up | 
| 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). | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | 
| 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). | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | 
| 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. | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 | 
| 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. | Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 |