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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
92
silicone hydrogel lens
silicone hydrogel lens
Eric White, O.D., Inc.
San Diego, California, United States
Mark Nakano, O.D.
Torrance, California, United States
Advanced Family Eye Care
Denver, North Carolina, United States
Quinn, Foster & Associates
Athens, Ohio, United States
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
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
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
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
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
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
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
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Western Reserve Vision Care, Inc.
Beachwood, Ohio, United States
Primary Eyecare Group, P.C.
Brentwood, Tennessee, United States
Time frame: 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
Time frame: 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;
Time frame: 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;
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
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
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
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
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
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
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