fanfilcon A (test)
Devicesilicone hydrogel lens
NCT Number: NCT02555722
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).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Eric White, O.D., Inc., San Diego, California, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
silicone hydrogel lens
silicone hydrogel lens
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Epithelial edema is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Epithelial edema is assessed for enfilcon A lens (control). Grading scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Stromal edema is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Stromal edema is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
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 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 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
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 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 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 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 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 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 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 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 is assessed for enfilcon A lens (control). Grading scale: absent/present
Time frame: Week 1, Week 2, Month 1, Month 2, Month 3
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 is assessed for enfilcon A lens (control) using Snellen chart.
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
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 lens wearing time for enfilcon A lens (control) measured in hours.
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Fanfilcon A lens (test) are assessed regarding comfort for the following: comfort upon insertion (CUI), comfort during the day (CDD), end of the day comfort (EDC), overall comfort (OC), and comfort at visit (CV). Subjects were asked to rate comfort from 0-5 (0=excellent, 1=very comfortable, 2=comfortable, 3=slightly uncomfortable, 4=very uncomfortable, or 5=causes pain).
Time frame: Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months follow-up
Enfilcon A lens (control) are assessed regarding comfort for the following: comfort upon insertion (CUI), comfort during the day (CDD), end of the day comfort (EDC), overall comfort (OC), and comfort at visit (CV). Subjects were asked to rate comfort from 0-5 (0=excellent, 1=very comfortable, 2=comfortable, 3=slightly uncomfortable, 4=very uncomfortable, or 5=causes pain).
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Overall vision quality (OVQ) and vision at night (VAN) is assessed at the specific time points. Subjects were asked to rate vision from 0-5, (0=excellent, 1=very good, 2=good, 3=poor, 4=very poor, 5= unacceptable).
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Overall vision quality (OVQ) and vision at night (VAN) is assessed at the specific time points. Subjects were asked to rate vision from 0-5, (0=excellent, 1=very good, 2=good, 3=poor, 4=very poor, 5= unacceptable).
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Ease of Insertion (EOI) and removal (EOR) was assessed. Subjects were asked to rate ease of insertion and removal on scale 0-5 (0=excellent, 1=very good, 2=good, 3=poor, 4=very poor, or 5=unmanageable.
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Ease of Insertion (EOI) and removal (EOR) was assessed. Subjects were asked to rate ease of insertion and removal on scale 0-5 (0=excellent, 1=very good, 2=good, 3=poor, 4=very poor, or 5=unmanageable.
CooperVision, Inc.
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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