MyopiaNCT02670473

Clinical Performance of Existing Wearers of Enfilcon A Following a Refit With Fanfilcon A Lenses for 4 Weeks

A study testing fanfilcon A (test) in people with Myopia, run by CooperVision, Inc. at 1 site in Spain.

Completed

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

Trial summary

The aim of this dispensing study is to evaluate the clinical performance of habitual wearers of enfilcon A lenses following a refit with fanfilcon A lenses over 4 weeks of daily wear. Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
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: 35 participants
Where: 1 siteSpain
Study dates: Jan 2016to 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 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

A person is eligible for inclusion in the study if he/she:
Is between 18 and 40 years of age
Has had a self-reported visual exam in the last two years
Is an adapted enfilcon A contact lens wearer (at least 2 weeks in enfilcon A lens)
Has a contact lens spherical prescription between -1.00 to - 6.00
Has a spectacle cylinder up to 0.75D (Diopters) in each eye.

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Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
Has clear corneas and no active ocular disease
Has read, understood, and signed the information consent letter.
Patient contact lens refraction should fit within the available parameters of the study lenses.
Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).
Is willing to comply with the visit schedule

Who cannot join

A person will be excluded from the study if he/she:
Is not a habitual wearer of enfilcon A lenses
Has a CL (Contact Lens) prescription outside the range of the available parameters of the study lenses.
Has a spectacle cylinder ≥1.00D of cylinder in either eye.
Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.

Show all 22Show fewer

Presence of clinically significant (grade 3-4) anterior segment abnormalities
Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
Slit lamp findings that would contraindicate contact lens wear such as:
Pathological dry eye or associated findings
Pterygium, pinguecula, or corneal scars within the visual axis
Neovascularization > 0.75 mm in from of the limbus
Giant papillary conjunctivitis (GCP) worse than grade 1
Anterior uveitis or iritis (past or present)
Seborrheic eczema, Seborrheic conjunctivitis
History of corneal ulcers or fungal infections
Poor personal hygiene
Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
Has aphakia, keratoconus or a highly irregular cornea.
Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
Has undergone corneal refractive surgery.
Is participating in any other type of eye related clinical or research study.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Optometry Research Group (GIO) Optics Department, University of Valencia
Valencia, 46100

Other trials in Spain

About this study

The aim of this dispensing study is to evaluate the clinical performance of habitual wearers of enfilcon A lenses following a refit with fanfilcon A lenses over 4 weeks of daily wear.

Read the detailed description

This is a 30 subject, prospective, dispensing, bilateral wear, subject-masked study, reviewing the refit characteristics in a group of enfilcon A wearers switched to the fanfilcon A lens. Subject's habitual enfilcon A lenses will be evaluated at the first vist and then re-fitted with a pair of fanfilcon A lenses for 4 weeks of daily wear. After the dispensing visit, subjects will return for evaluations at 1 week, 2 weeks, and 4 weeks.

Conditions: Myopia
Being tested: fanfilcon A (test)
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
contact lens

Study groups in NCT02670473
Study group	Role	What they receive
enfilcon A (habitual)	No intervention	Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens.
fanfilcon A (test)	Experimental	Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens. Receives: Device: fanfilcon A (test)

What is being measured

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

Lens Fit - Centration
Lens fit evaluation of centration for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: optimum, decentration acceptable, decentration unacceptable.
Measured: Baseline, 1 week, 2 weeks, and 4 weeks
Lens Fit - Post-blink Movement
Lens fit evaluation of post-blink movement for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-5 Likert scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement.
Measured: Baseline, 1 week, 2 weeks, and 4 weeks
Lens Tightness on Push-up
Lens fit evaluation of tightness on push-up test for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: 0%-100%, 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement.
Measured: Baseline, 1 week, 2 weeks, and 4 weeks
Overall Fit Acceptance
Overall fit acceptance for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimum acceptable, early review, 3=Not perfect but okay to dispense, 4=Perfect.
Measured: Baseline, 1 week, 2 weeks, and 4 weeks

Secondary outcomes (9)

Overall Comfort
Subjective rating of overall comfort for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=could feel, 10=cannot feel.
Measured: Baseline, 1 week, 2 weeks, and 4 weeks
Dryness Overall
Subjective rating of overall dryness for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very dry, 10=no dryness.
Measured: Baseline, 1 week, 2 weeks, and 4 weeks
Handling
Subjective rating of handling for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very difficult to handle, 10=very easy to handle.
Measured: Baseline, 1 week, 2 weeks, and 4 weeks
Overall Vision Satisfaction
Subjective rating of overall vision satisfaction for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very dissatisfied, 10=very satisfied.
Measured: Baseline, 1 week, 2 weeks, and 4 weeks
Overall Satisfaction
Subjective rating of overall satisfaction for enfilcon A habitual lens (control) at baseline and fanfilcon A lens (test) at 1 week, 2 weeks, and 4 weeks. Scale 1-4, 1=completely satisfied, 2=somewhat satisfied, 3=somewhat dissatisfied, 4=completely dissatisfied.
Measured: Baseline, 1 week, 2 weeks, and 4 weeks
Lens Preference Overall
Subject's overall preference for one of two contact lenses. Forced choice: enfilcon A habitual lens (control) or fanfilcon A lens (test).
Measured: 1 week, 2 weeks, and 4 weeks
Wearing Times
Average wearing time and comfortable wearing times for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks measured by hours.
Measured: Baseline, 1 week, 2 weeks, and 4 weeks
Conjunctival Staining
Conjunctival staining for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. (Scale 0-4, 0.5 steps 0=normal, 4=severe).
Measured: Baseline, 1 week, 2 weeks, and 4 weeks
Corneal Staining
Corneal staining for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0.5 steps 0=normal, 4=severe.
Measured: Baseline, 1 week, 2 weeks, and 4 weeks

Timeline

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

Jan 2016May 2016

First posted1 Feb 2016 (estimated)
Study startJan 2016
Primary completionMar 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: Non-randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02670473
Sponsor's protocol ID: EX-MKTG-55 (CV-15-09)
Status last verified: Jul 2017
First submitted: 28 Jan 2016
Last updated: 5 Feb 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Performance of Existing Wearers of Enfilcon A Following a Refit With Fanfilcon A Lenses for 4 Weeks
ClinicalTrials.gov ID: NCT02670473
Acronym / sponsor ID: EX-MKTG-55 (CV-15-09)
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: Jan 2016
Primary completion: Mar 2016 (actual)
Study completion: May 2016 (actual)
First posted: 1 Feb 2016 (estimated)
Results: Posted 21 Mar 2017

Clinical summary

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

The aim of this dispensing study is to evaluate the clinical performance of habitual wearers of enfilcon A lenses following a refit with fanfilcon A lenses over 4 weeks of daily wear.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
enfilcon A (habitual)	No intervention	–Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens.
fanfilcon A (test)	Experimental	Device: fanfilcon A (test)Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (13 listed)

Is between 18 and 40 years of age
Has had a self-reported visual exam in the last two years
Is an adapted enfilcon A contact lens wearer (at least 2 weeks in enfilcon A lens)
Has a contact lens spherical prescription between -1.00 to - 6.00
Has a spectacle cylinder up to 0.75D (Diopters) in each eye.

Key exclusion criteria (22 listed)

Is not a habitual wearer of enfilcon A lenses
Has a CL (Contact Lens) prescription outside the range of the available parameters of the study lenses.
Has a spectacle cylinder ≥1.00D of cylinder in either eye.
Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.

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)contact lens	Device	fanfilcon A (test)

Primary outcome

Lens Fit - Centration
Time frame: Baseline, 1 week, 2 weeks, and 4 weeks
Lens fit evaluation of centration for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: optimum, decentration acceptable, decentration unacceptable.
Lens Fit - Post-blink Movement
Time frame: Baseline, 1 week, 2 weeks, and 4 weeks
Lens fit evaluation of post-blink movement for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-5 Likert scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement.
Lens Tightness on Push-up
Time frame: Baseline, 1 week, 2 weeks, and 4 weeks
Lens fit evaluation of tightness on push-up test for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: 0%-100%, 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement.
Overall Fit Acceptance
Time frame: Baseline, 1 week, 2 weeks, and 4 weeks
Overall fit acceptance for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimum acceptable, early review, 3=Not perfect but okay to dispense, 4=Perfect.

9 secondary outcomes

Overall Comfort
Time frame: Baseline, 1 week, 2 weeks, and 4 weeks
Dryness Overall
Time frame: Baseline, 1 week, 2 weeks, and 4 weeks
Handling
Time frame: Baseline, 1 week, 2 weeks, and 4 weeks
Overall Vision Satisfaction
Time frame: Baseline, 1 week, 2 weeks, and 4 weeks
Overall Satisfaction
Time frame: Baseline, 1 week, 2 weeks, and 4 weeks
Lens Preference Overall
Time frame: 1 week, 2 weeks, and 4 weeks
Wearing Times
Time frame: Baseline, 1 week, 2 weeks, and 4 weeks
Conjunctival Staining
Time frame: Baseline, 1 week, 2 weeks, and 4 weeks
Corneal Staining
Time frame: Baseline, 1 week, 2 weeks, and 4 weeks

Results and safety

Results posted to the registry on 21 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
Overall Participants	35	34

Primary outcome: Lens Fit - Centration

Time frame: Baseline, 1 week, 2 weeks, and 4 weeks. Number. Unit: percentage of eyes

Measure	Habitual Lenses: Baseline n = 35	Fanfilcon A: 1 Week n = 35	Fanfilcon A: 2 Weeks n = 34	Fanfilcon A: 4 Weeks n = 34
Optimum	88	97	99	100
Decentration acceptable	12	3	1	0
Decentration unacceptable	0	0	0	0

Primary outcome: Lens Fit - Post-blink Movement

Time frame: Baseline, 1 week, 2 weeks, and 4 weeks. Number. Unit: percentage of eyes

Measure	Habitual Lenses: Baseline n = 35	Fanfilcon A: 1 Week n = 35	Fanfilcon A: 2 Weeks n = 34	Fanfilcon A: 4 Weeks n = 34
Insufficient, unacceptable movement	0	0	0	0
Minimal, but acceptable movement	1	1	0	0
Optimal movement	35	3	6	18
Moderate, but acceptable movement	64	96	91	79
Excessive, unacceptable movement	0	0	3	3

Primary outcome: Lens Tightness on Push-up

Time frame: Baseline, 1 week, 2 weeks, and 4 weeks. Mean (Standard Deviation). Unit: percentage of lens tightness

Measure	Habitual Lenses: Baseline n = 35	Fanfilcon A: 1 Week n = 35	Fanfilcon A: 2 Weeks n = 34	Fanfilcon A: 4 Weeks n = 34
Value	50 (5)	49 (2)	50 (3)	50 (3)

Primary outcome: Overall Fit Acceptance

Time frame: Baseline, 1 week, 2 weeks, and 4 weeks. Number. Unit: percentage of eyes

Measure	Habitual Lenses: Baseline n = 35	Fanfilcon A: 1 Week n = 35	Fanfilcon A: 2 Weeks n = 34	Fanfilcon A: 4 Weeks n = 34
Should not be worn	0	0	0	0
Borderline but unacceptable	0	0	0	0
Minimum acceptable	0	0	0	0
Not perfect but okay	9	0	7	3
Perfect	91	100	93	97

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Overall Participants	0 of 35 (0%)	0 of 35 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
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.

Robert Montés-Mico, O.D., PhD principal investigator

Optometry Research Group (GIO) University of Valencia

1 site 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 1 site in Spain.

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 22 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 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. 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 21 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?

Lens Fit - Centration (time frame: Baseline, 1 week, 2 weeks, and 4 weeks). The study lists 4 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 NCT02670473.

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 5 Feb 2018.