MyopiaNCT02555722

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

A study testing fanfilcon A (test) in people with Myopia, run by CooperVision, Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myopia
What is being tested?: fanfilcon A (test)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 92 participants
Where: 6 sitesUnited States
Study dates: 21 Sep 2015to May 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Show all 13Show fewer

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.

Who cannot join

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.

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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

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

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

Other trials in United States

About this study

Read the 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.

Conditions: Myopia
Being tested: fanfilcon A (test), enfilcon A (control)
Medical subject headings: Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02555722
Study group	Role	What they receive
fanfilcon A (test)	Experimental	Subjects will be randomized to wear fanfilcon A lens (test) for one month of daily wear during the study. Receives: 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. Receives: Device: enfilcon A (control)

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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;
Measured: 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;
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3

Secondary outcomes (6)

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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Sep 2015May 2016

First posted21 Sep 2015 (estimated)
Study start21 Sep 2015
Primary completion27 Jan 2016
Study completionMay 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for MyopiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 92 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02555722
Sponsor's protocol ID: FC150625
Status last verified: Sep 2019
First submitted: 16 Sep 2015
Last updated: 25 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruiting
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High Myopia, Intraocular Pressure
Recruiting
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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02555722
Acronym / sponsor ID: FC150625
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 92 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 21 Sep 2015 (actual)
Primary completion: 27 Jan 2016 (actual)
Study completion: May 2016 (actual)
First posted: 21 Sep 2015 (estimated)
Results: Posted 8 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
fanfilcon A (test)	Experimental	Device: fanfilcon A (test)Subjects will be randomized to wear fanfilcon A lens (test) for one month of daily wear during the study.
enfilcon A (control)	Active comparator	Device: enfilcon A (control)Subjects will be randomized to wear enfilcon A lens (control) for one month of daily wear during the study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Be at least 18 years of age as of the date of evaluation for the study.
Have:
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.

Key exclusion criteria (21 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
fanfilcon A (test)silicone hydrogel lens	Device	fanfilcon A (test)
enfilcon A (control)silicone hydrogel lens	Device	enfilcon A (control)

Primary outcome

Epithelial Edema - Fanfilcon A Lens (Test)
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
Epithelial Edema - Enfilcon A Lens (Control)
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
Stromal Edema - Fanfilcon A Lens (Test)
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
Stromal Edema - Enfilcon A Lens (Control)
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
Corneal Infiltrates - Fanfilcon A Lens (Test)
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
Corneal Infiltrates - Enfilcon A Lens (Control)
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
Corneal Vascularization - Fanfilcon A Lens (Test)
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
Corneal Vascularization - Enfilcon A Lens (Control)
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
Corneal Staining - Fanfilcon A Lens (Test)
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;
Corneal Staining - Enfilcon A Lens (Control)
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;
Limbal Hyperemia - Fanfilcon A Lens (Test)
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
Limbal Hyperemia - Enfilcon A Lens (Control)
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
Bulbar Hyperemia - Fanfilcon A Lens (Test)
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
Bulbar Hyperemia - Enfilcon A Lens (Control)
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
Palpebral Conjunctiva - Fanfilcon A Lens (Test)
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
Palpebral Conjunctiva - Enfilcon A Lens (Control)
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
Visual Acuity - Fanfilcon A Lens (Test)
Time frame: Week 1, Week 2, Month 1, Month 2, Month 3
Visual acuity is assessed for fanfilcon A lens (test) using Snellen chart.
Visual Acuity - Enfilcon A Lens (Control)
Time frame: Week 1, Week 2, Month 1, Month 2, Month 3
Visual acuity is assessed for enfilcon A lens (control) using Snellen chart.
Average Wearing Time - Fanfilcon A Lens (Test)
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.
Average Wearing Time - Enfilcon A Lens (Control)
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.

6 secondary outcomes

Comfort - Fanfilcon A Lens (Test)
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Comfort - Enfilcon A Lens (Control)
Time frame: Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months follow-up
Overall Vision Quality - Fanfilcon A Lens (Test)
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Overall Vision Quality - Enfilcon A Lens (Control)
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Ease of Insertion and Removal - Fanfilcon A Lens (Test)
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Ease of Insertion and Removal - Enfilcon A Lens (Control)
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3

Results and safety

Results posted to the registry on 8 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fanfilcon A (Test)	60	60
Enfilcon A (Control)	30	30

Primary outcome: Epithelial Edema - Fanfilcon A Lens (Test)

Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3. Number. Unit: percentage of eyes

Measure	Baseline n = 54	Week 1 n = 54	Week 2 n = 53	Month 1 n = 54	Month 2 n = 54	Month 3 n = 54	Unscheduled n = 2
None	100.0	100.0	99.1	100.0	100.0	100.0	100.0
Trace	0.0	0.0	0.9	0.0	0.0	0.0	0.0
Mild	0.0	0.0	0.0	0.0	0.0	0.0	0.0
Moderate	0.0	0.0	0.0	0.0	0.0	0.0	0.0
Severe	0.0	0.0	0.0	0.0	0.0	0.0	0.0

Population analysed: All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3.

Primary outcome: Epithelial Edema - Enfilcon A Lens (Control)

Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3. Number. Unit: percentage of eyes

Measure	Baseline n = 29	Week 1 n = 26	Week 2 n = 29	Month 1 n = 29	Month 2 n = 28	Month 3 n = 29	Unscheduled n = 3
None	100.0	100.0	100.0	100.0	100.0	100.0	100.0
Trace	0.0	0.0	0.0	0.0	0.0	0.0	0.0
MIld	0.0	0.0	0.0	0.0	0.0	0.0	0.0
Moderate	0.0	0.0	0.0	0.0	0.0	0.0	0.0
Severe	0.0	0.0	0.0	0.0	0.0	0.0	0.0

Population analysed: All sites, control completed subjects' eyes Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.

Primary outcome: Stromal Edema - Fanfilcon A Lens (Test)

Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3. Number. Unit: percentage of eyes

Measure	Baseline n = 54	Week 1 n = 54	Week 2 n = 53	Month 1 n = 54	Month 2 n = 54	Month 3 n = 54	Unscheduled n = 2
None	100.0	100.0	99.1	100.0	100.0	100.0	100.0
Trace	0.0	0.0	0.9	0.0	0.0	0.0	0.0
Mild	0.0	0.0	0.0	0.0	0.0	0.0	0.0
Moderate	0.0	0.0	0.0	0.0	0.0	0.0	0.0
Severe	0.0	0.0	0.0	0.0	0.0	0.0	0.0

Population analysed: All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected during at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3.

Primary outcome: Stromal Edema - Enfilcon A Lens (Control)

Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3. Number. Unit: percentage of eyes

Measure	Baseline n = 29	Week 1 n = 26	Week 2 n = 29	Month 1 n = 29	Month 2 n = 28	Month 3 n = 29	Unscheduled n = 3
None	100.0	100.0	100.0	100.0	100.0	100.0	100.0
Trace	0.0	0.0	0.0	0.0	0.0	0.0	0.0
Mild	0.0	0.0	0.0	0.0	0.0	0.0	0.0
Moderate	0.0	0.0	0.0	0.0	0.0	0.0	0.0
Severe	0.0	0.0	0.0	0.0	0.0	0.0	0.0

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fanfilcon A (Test)	0 of 60 (0%)	0 of 60 (0%)	0 of 60
Enfilcon A (Control)	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eric M White, OD principal investigator

Eric White, O.D., Inc.

Peter T Van Hoven, OD principal investigator

Primary Eyecare Group, P.C.

Amanda L Barker, OD principal investigator

Advanced Family Eye Care

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing fanfilcon A (test) in people with Myopia, run by CooperVision, Inc. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Epithelial Edema - Fanfilcon A Lens (Test) (time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02555722.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.