MyopiaNCT02423109

Bilateral Dispensing Study of Fanfilcon A Toric Versus Enfilcon A Toric Lenses

A study testing fanfilcon A and enfilcon A in people with Myopia and Hyperopia, run by CooperVision, Inc. at 2 sites in 2 countries.

Completed

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

Official record

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Trial summary

Bilateral dispensing clinical trial of fanfilcon A toric lens verses enfilcon A toric lens over two weeks. Read more about this study

Who is it for?: Ages 17 years and older
Conditions the study is for: Myopia, Hyperopia, Astigmatism
What is being tested?: fanfilcon A and enfilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 2 sitesin 2 countries
Study dates: Sep 2015to Mar 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 17 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Are at least 17 years of age for Canada and 18 years of age for the USA and have full legal capacity to volunteer;
Have read and signed an information consent letter;
Are willing and able to follow instructions and maintain the appointment schedule;
Are an adapted soft contact lens wearer;
Require spectacle lens powers in both eyes;
Sphere: between -0.50 to -6.00 diopters and

Show all 11Show fewer

Astigmatism: between -1.25 to -2.00 and
Axis: 180 ± 20 degrees
Are willing to wear contact lens in both eyes;
Have manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye;
To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit including toric orientation as acceptable;

Who cannot join

Are participating in any concurrent clinical or research study;
Have any known active* ocular disease and/or infection;
Have a systemic condition that in the opinion of the investigator may affect a study outcome variable;
Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
Have known sensitivity to the diagnostic pharmaceuticals to be used in the study;
Are pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
Are aphakic;
Have undergone refractive error surgery;

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

United States1 site

Clinical Research Center, University of California, Berkeley
Berkeley, California, 94704

Other trials in United States

Canada1 site

Center for Contact Lens Research, University of Waterloo
Waterloo, Ontario, N2L 3G1

Other trials in Canada

About this study

Bilateral dispensing clinical trial of fanfilcon A toric lens verses enfilcon A toric lens over two weeks.

Read the detailed description

Evaluation of the clinical performance of an investigational silicone-hydrogel lens called fanfilcon A (test) compared to a FDA-cleared commercially available contact lens called enfilcon A toric lens (control) when worn on a daily wear basis over 2 weeks in a randomized, bilateral, cross-over, dispensing study.

Conditions: Myopia, Hyperopia, Astigmatism
Being tested: fanfilcon A, enfilcon A
Medical subject headings: Myopia, Hyperopia, Astigmatism

What participants receive

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

fanfilcon ADevice
contact lens
enfilcon ADevice
contact lens

Study groups in NCT02423109
Study group	Role	What they receive
fanfilcon A	Experimental	Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair. Receives: Device: fanfilcon A; Device: enfilcon A
enfilcon A	Active comparator	Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair. Receives: Device: fanfilcon A; Device: enfilcon A

What is being measured

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

Comfort (Subjective Rating Scale)
Participant rating for comfort at dispense visit and at the 2 week follow-up on a subjective rating scale (0-100, 0=cannot be worn. Causes pain,100=Cannot be felt ever)
Measured: Dispensing (Baseline) and 2 weeks
Comfort Preference
Subjective assessment for comfort preference for each lens pair. Choices: fanfilcon A lens, enfilcon A lens, No preference.
Measured: Dispensing (Baseline) and 2 weeks

Timeline

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

Sep 2015Mar 2016

First posted22 Apr 2015 (estimated)
Study startSep 2015
Primary completionJan 2016
Study completionMar 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: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02423109
Sponsor's protocol ID: CV-15-13
Status last verified: Jan 2018
First submitted: 17 Apr 2015
Last updated: 10 Jan 2018
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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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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Clinical Performance and Outcomes After Toric Lens Transition
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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bilateral Dispensing Study of Fanfilcon A Toric Versus Enfilcon A Toric Lenses
ClinicalTrials.gov ID: NCT02423109
Acronym / sponsor ID: CV-15-13
Conditions: Myopia, Hyperopia, Astigmatism
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: Sep 2015
Primary completion: Jan 2016 (actual)
Study completion: Mar 2016 (actual)
First posted: 22 Apr 2015 (estimated)
Results: Posted 10 Jan 2018

Clinical summary

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

Bilateral dispensing clinical trial of fanfilcon A toric lens verses enfilcon A toric lens over two weeks.

Detailed description

Study design

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

Arm	Type	Receives
fanfilcon A	Experimental	Device: fanfilcon A, Device: enfilcon AEach subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair.
enfilcon A	Active comparator	Device: fanfilcon A, Device: enfilcon AEach subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair.

Who may qualify

Ages: 17 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (11 listed)

Are at least 17 years of age for Canada and 18 years of age for the USA and have full legal capacity to volunteer;
Have read and signed an information consent letter;
Are willing and able to follow instructions and maintain the appointment schedule;
Are an adapted soft contact lens wearer;
Require spectacle lens powers in both eyes;

Key exclusion criteria (8 listed)

Are participating in any concurrent clinical or research study;
Have any known active* ocular disease and/or infection;
Have a systemic condition that in the opinion of the investigator may affect a study outcome variable;
Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
Have known sensitivity to the diagnostic pharmaceuticals to be used in the study;

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 Acontact lens	Device	enfilcon A, fanfilcon A
enfilcon Acontact lens	Device	enfilcon A, fanfilcon A

Primary outcome

Comfort (Subjective Rating Scale)
Time frame: Dispensing (Baseline) and 2 weeks
Participant rating for comfort at dispense visit and at the 2 week follow-up on a subjective rating scale (0-100, 0=cannot be worn. Causes pain,100=Cannot be felt ever)
Comfort Preference
Time frame: Dispensing (Baseline) and 2 weeks
Subjective assessment for comfort preference for each lens pair. Choices: fanfilcon A lens, enfilcon A lens, No preference.

Results and safety

Results posted to the registry on 10 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Randomized for Fanfilcon A Lens First, Then Enfilcon A Lens	19	18
Randomized for Enfilcon A Lens First, Then Fanfilcon A Lens	14	14

Primary outcome: Comfort (Subjective Rating Scale)

Time frame: Dispensing (Baseline) and 2 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Fanfilcon A n = 15	Enfilcon A n = 16
Dispensing	87 (17)	88 (10)
2 week	79 (15)	76 (18)

Population analysed: Analysis population differs slightly due to 1 participant who was excluded from analysis due to a protocol deviation.

Primary outcome: Comfort Preference

Time frame: Dispensing (Baseline) and 2 weeks. Count of participants. Unit: Participants

Measure	Overall Study - Dispense n = 31	Overall Study - Follow Up n = 31
fanfilcon A	12	14
enfilcon A	10	12
No Preference	9	5

Population analysed: Analysis population differs slightly due to protocol deviation.

Adverse events

Time frame: Adverse event data were collected through the duration of the study (2 weeks for each lens).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fanfilcon A	0 of 33 (0%)	0 of 33 (0%)	0 of 33
Enfilcon A	0 of 32 (0%)	0 of 32 (0%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

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.

Meng Lin, OD PhD principal investigator

Clinical Research Center, University of California, Berkeley

Lyndon Jones, PhD FCO principal investigator

Center for Contact Lens Research, University of Waterloo

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing fanfilcon A and enfilcon A in people with Myopia and Hyperopia, run by CooperVision, Inc. at 2 sites in 2 countries.

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 11 inclusion and 8 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 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Canada. 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 10 Jan 2018). 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?

Comfort (Subjective Rating Scale) (time frame: Dispensing (Baseline) and 2 weeks). The study lists 2 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 NCT02423109.

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 10 Jan 2018.