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

NCT02555722 | Completed Results FDA Device

• 1 other identifier: FC150625
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 6

Brief 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).

Conditions

Myopia

Outcome Measures

Primary Outcomes (20)

• 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 Outcomes (6)

• Comfort - Fanfilcon A Lens (Test)

  Baseline, Week 1, Week 2, Month 1, Month 2, Month 3

• Comfort - Enfilcon A Lens (Control)

  Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months follow-up

• Overall Vision Quality - Fanfilcon A Lens (Test)

  Baseline, Week 1, Week 2, Month 1, Month 2, Month 3

• Overall Vision Quality - Enfilcon A Lens (Control)

  Baseline, Week 1, Week 2, Month 1, Month 2, Month 3

• Ease of Insertion and Removal - Fanfilcon A Lens (Test)

  Baseline, Week 1, Week 2, Month 1, Month 2, Month 3

Study Arms (2)

fanfilcon A (test)

EXPERIMENTAL

Subjects will be randomized to wear fanfilcon A lens (test) for one month of daily wear during the study.

Device: fanfilcon A (test)

enfilcon A (control)

ACTIVE COMPARATOR

Subjects will be randomized to wear enfilcon A lens (control) for one month of daily wear during the study.

Device: enfilcon A (control)

Interventions

fanfilcon A (test) DEVICE

silicone hydrogel lens

fanfilcon A (test)

enfilcon A (control) DEVICE

silicone hydrogel lens

enfilcon A (control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (6)

Eric White, O.D., Inc.

San Diego, California, 92123, United States

Location

Mark Nakano, O.D.

Torrance, California, 90503, United States

Location

Advanced Family Eye Care

Denver, North Carolina, 28037, United States

Location

Quinn, Foster & Associates

Athens, Ohio, 45701, United States

Location

Western Reserve Vision Care, Inc.

Beachwood, Ohio, 44122, United States

Location

Primary Eyecare Group, P.C.

Brentwood, Tennessee, 37027-7552, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Senior Manager, Clinical Research
• Organization: CooperVision Inc.

PChamberlain@coopervision.com

925-730-6754

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2015
• First Posted: September 21, 2015
• Study Start: September 21, 2015
• Primary Completion: January 27, 2016
• Study Completion: May 1, 2016
• Last Updated: September 25, 2019
• Results First Posted: March 8, 2017

Record last verified: 2019-09

Locations

US (6)