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

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).

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: fanfilcon A (test); Device: enfilcon A (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.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Eric White, O.D., Inc.
    • Torrance, California, United States, 90503
      • Mark Nakano, O.D.
  • North Carolina
    • Denver, North Carolina, United States, 28037
      • Advanced Family Eye Care
  • Ohio
    • Athens, Ohio, United States, 45701
      • Quinn, Foster & Associates
    • Beachwood, Ohio, United States, 44122
      • Western Reserve Vision Care, Inc.
  • Tennessee
    • Brentwood, Tennessee, United States, 37027-7552
      • Primary Eyecare Group, P.C.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Eric M White, OD, Eric White, O.D., Inc.; Principal Investigator: Peter T Van Hoven, OD, Primary Eyecare Group, P.C.; Principal Investigator: Amanda L Barker, OD, Advanced Family Eye Care; Principal Investigator: Mark E Nakano, OD, Mark Nakano, O.D.; Principal Investigator: Thomas G Quinn, OD, Quinn, Foster & Associates; Principal Investigator: Mary Jo Stiegemeier, OD, Western Reserve Vision Care, Inc

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2015
• Primary Completion (Actual): January 27, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: September 16, 2015
• First Submitted That Met QC Criteria: September 18, 2015
• First Posted (Estimate): September 21, 2015

Study Record Updates

• Last Update Posted (Actual): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 16, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: FC150625

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes