N/A
Completed N=90
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
Source: ClinicalTrials.gov NCT02555722 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Epithelial Edema - Fanfilcon A Lens (Test) — 100.0; 100.0; 99.1; 100.0 percentage of eyes
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Epithelial Edema - Fanfilcon A Lens (Test) |
100.0; 100.0; 99.1; 100.0; 100.0; 100.0 | — |
| PRIMARY Epithelial Edema - Enfilcon A Lens (Control) |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| PRIMARY Stromal Edema - Fanfilcon A Lens (Test) |
100.0; 100.0; 99.1; 100.0; 100.0; 100.0 | — |
| PRIMARY Stromal Edema - Enfilcon A Lens (Control) |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| PRIMARY Corneal Infiltrates - Fanfilcon A Lens (Test) |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| PRIMARY Corneal Infiltrates - Enfilcon A Lens (Control) |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| PRIMARY Corneal Vascularization - Fanfilcon A Lens (Test) |
90.7; 92.6; 92.5; 92.6; 94.4; 91.7 | — |
| PRIMARY Corneal Vascularization - Enfilcon A Lens (Control) |
86.2; 92.3; 93.1; 93.1; 96.4; 96.6 | — |
| PRIMARY Corneal Staining - Fanfilcon A Lens (Test) |
96.3; 92.6; 93.4; 93.5; 97.2; 96.3 | — |
| PRIMARY Corneal Staining - Enfilcon A Lens (Control) |
75.9; 84.6; 96.6; 93.1; 78.6; 93.1 | — |
| PRIMARY Limbal Hyperemia - Fanfilcon A Lens (Test) |
80.6; 88.9; 76.4; 80.6; 82.4; 75.9 | — |
| PRIMARY Limbal Hyperemia - Enfilcon A Lens (Control) |
79.3; 80.8; 93.1; 93.1; 92.9; 87.9 | — |
| PRIMARY Bulbar Hyperemia - Fanfilcon A Lens (Test) |
60.2; 77.8; 67.0; 68.5; 73.1; 69.4 | — |
| PRIMARY Bulbar Hyperemia - Enfilcon A Lens (Control) |
65.5; 61.5; 72.4; 69.0; 92.9; 81.0 | — |
| PRIMARY Palpebral Conjunctiva - Fanfilcon A Lens (Test) |
69.4; 64.8; 63.2; 67.6; 60.2; 58.3 | — |
| PRIMARY Palpebral Conjunctiva - Enfilcon A Lens (Control) |
55.2; 69.2; 62.1; 58.6; 67.9; 67.2 | — |
| PRIMARY Visual Acuity - Fanfilcon A Lens (Test) |
27; 26; 27; 27; 27; 78 | — |
| PRIMARY Visual Acuity - Enfilcon A Lens (Control) |
14; 14; 14; 14; 14; 36 | — |
| PRIMARY Average Wearing Time - Fanfilcon A Lens (Test) |
14.17; 13.25; 13.08; 13.18; 13.21; 13.13 | — |
| PRIMARY Average Wearing Time - Enfilcon A Lens (Control) |
13.81; 13.67; 13.41; 13.52; 13.20; 13.62 | — |
| SECONDARY Comfort - Fanfilcon A Lens (Test) |
50; 50; 67; 61; 60; 64 | — |
| SECONDARY Comfort - Enfilcon A Lens (Control) |
20; 16; 30; 20; 28; 26 | — |
| SECONDARY Overall Vision Quality - Fanfilcon A Lens (Test) |
53; 70; 68; 64; 64; 70 | — |
| SECONDARY Overall Vision Quality - Enfilcon A Lens (Control) |
23; 28; 28; 22; 30; 25 | — |
| SECONDARY Ease of Insertion and Removal - Fanfilcon A Lens (Test) |
78; 70; 72; 73; 68; 72 | — |
| SECONDARY Ease of Insertion and Removal - Enfilcon A Lens (Control) |
34; 31; 36; 30; 36; 30 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02555722). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.