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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02555722
• Other study ID #: FC150625
• Status: Completed
• Phase: N/A
• Start date: September 21, 2015
• Est. completion date: May 2016

Study information

• Verified date: September 2019
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: May 2016
• Est. primary completion date: January 27, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• fanfilcon A (test)
silicone hydrogel lens
• enfilcon A (control)
silicone hydrogel lens

Locations

Country	Name	City	State
United States	Quinn, Foster & Associates	Athens	Ohio
United States	Western Reserve Vision Care, Inc.	Beachwood	Ohio
United States	Primary Eyecare Group, P.C.	Brentwood	Tennessee
United States	Advanced Family Eye Care	Denver	North Carolina
United States	Eric White, O.D., Inc.	San Diego	California
United States	Mark Nakano, O.D.	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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