MyopiaNCT02716298

A Dispensing Clinical of Fanfilcon A Lens Against Lotrafilcon B Lens Over 1 Month Wear Per Lens

A study testing fanfilcon A and lotrafilcon B in people with Myopia, run by CooperVision, Inc. at 1 site in Canada.

Completed

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

Trial summary

This is a study to evaluate the performance of fanfilcon A lens when worn on a daily wear modality over approximately 1 month in comparison to the lotrafilcon B lens. Read more about this study

Who is it for?: Ages 17 years and older
Conditions the study is for: Myopia
What is being tested?: fanfilcon A and lotrafilcon B
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 49 participants
Where: 1 siteCanada
Study dates: Mar 2016to Aug 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

A person is eligible for inclusion in the study if he/she:
Is at least 17 years of age and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction and the assigned study lenses;
Is an adapted soft contact lens wearer (For the purpose of this study: Current lens wear at least 3 days per week, 8 hours each day);
Demonstrates an acceptable fit with the study lenses.

Who cannot join

A person will be excluded from the study if he/she:
Is participating in any concurrent clinical or research study;
Is a habitual wearer of lotrafilcon B or enfilcon A lenses.
Has any known active* ocular disease and/or infection;
Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;

Show all 11Show fewer

Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
Is pregnant, lactating or planning a pregnancy at the time of enrollment; (by verbal confirmation at the Screening Visit)
Is aphakic;
Has undergone refractive error surgery;
For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Trial locations and contacts

1 site in 1 country.

Canada1 site

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

Other trials in Canada

About this study

This is a study to evaluate the performance of fanfilcon A lens when worn on a daily wear modality over approximately 1 month in comparison to the lotrafilcon B lens.

Read the detailed description

This is a 45 subject, 1-month dispensing, crossover, double-masked, randomized, bilateral study comparing the test lens against the control lens. Both test and control lenses will be used in a daily wear modality for 1 month each.

Conditions: Myopia
Being tested: fanfilcon A, lotrafilcon B
Medical subject headings: Myopia

What participants receive

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

fanfilcon ADevice
contact lens
lotrafilcon BDevice
contact lens

Study groups in NCT02716298
Study group	Role	What they receive
fanfilcon A	Active comparator	Study participants are randomized to wear fanfilcon A lens during the crossover study Receives: Device: fanfilcon A
lotrafilcon B	Active comparator	Study participants are randomized to wear lotrafilcon B lens during the crossover study. Receives: Device: lotrafilcon B

What is being measured

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

Subjective Comfort
Subjective ratings on comfort at insertion (at baseline), comfort when lenses are first put in, comfort during the day's wear, and comfort prior to lens removal (1 month) for fanfilcon A and lotrafilcon B lens. (Scale 0-10, 10=Can't feel the lenses, 0=Painful).
Measured: Baseline, 1 month
Subjective Preference
Subjective ratings on preference for fanfilcon A and lotrafilcon B lens. (Strongly prefer fanfilcon A, slightly prefer fanfilcon A, no preference, slightly prefer lotrafilcon B, strongly prefer lotrafilcon B).
Subject preference in terms of comfort, dryness, clear vision, Lens Handling, digital devices, all day natural comfort, All day comfort, same comfort at the end of the day (EOD), comfortable after the end of 4 weeks, Same comfort at 4 weeks as initial, comfortable in dry environments, help focus effortlessly while using digital devices, help with end of day (EOD) dryness, help eyes feel less tired at EOD (including computer or digital device use), offering clear vision during driving.
Measured: 1 month
Lens Wettability
Lens wettability for fanfilcon A and lotrafilcon B lens. (Scale 0-4, 0.25 steps, 0=excellent, 4=severely reduced)
Measured: Baseline, 1 month
Surface Deposits
Surface deposits for fanfilcon A and lotrafilcon B lens. (Scale 0-4, 0.25 steps, 0=excellent, 4=severely reduced)
Measured: Baseline, 1 month

Timeline

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

Mar 2016Aug 2016

First posted23 Mar 2016 (estimated)
Study startMar 2016
Primary completionJun 2016
Study completionAug 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: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02716298
Sponsor's protocol ID: EX-MKTG-64
Status last verified: Apr 2017
First submitted: 17 Mar 2016
Last updated: 30 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: 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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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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Active, not recruiting
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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Dispensing Clinical of Fanfilcon A Lens Against Lotrafilcon B Lens Over 1 Month Wear Per Lens
ClinicalTrials.gov ID: NCT02716298
Acronym / sponsor ID: EX-MKTG-64
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: Mar 2016
Primary completion: Jun 2016 (actual)
Study completion: Aug 2016 (actual)
First posted: 23 Mar 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.

This is a study to evaluate the performance of fanfilcon A lens when worn on a daily wear modality over approximately 1 month in comparison to the lotrafilcon B lens.

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	Active comparator	Device: fanfilcon AStudy participants are randomized to wear fanfilcon A lens during the crossover study
lotrafilcon B	Active comparator	Device: lotrafilcon BStudy participants are randomized to wear lotrafilcon B lens during the crossover study.

Who may qualify

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

Key inclusion criteria (7 listed)

Is at least 17 years of age and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction and the assigned study lenses;
Is an adapted soft contact lens wearer (For the purpose of this study: Current lens wear at least 3 days per week, 8 hours each day);

Key exclusion criteria (11 listed)

Is participating in any concurrent clinical or research study;
Is a habitual wearer of lotrafilcon B or enfilcon A lenses.
Has any known active* ocular disease and/or infection;
Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;

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	fanfilcon A
lotrafilcon Bcontact lens	Device	lotrafilcon B

Primary outcome

Subjective Comfort
Time frame: Baseline, 1 month
Subjective ratings on comfort at insertion (at baseline), comfort when lenses are first put in, comfort during the day's wear, and comfort prior to lens removal (1 month) for fanfilcon A and lotrafilcon B lens. (Scale 0-10, 10=Can't feel the lenses, 0=Painful).
Subjective Preference
Time frame: 1 month
Subjective ratings on preference for fanfilcon A and lotrafilcon B lens. (Strongly prefer fanfilcon A, slightly prefer fanfilcon A, no preference, slightly prefer lotrafilcon B, strongly prefer lotrafilcon B). Subject preference in terms of comfort, dryness, clear vision, Lens Handling, digital devices, all day natural comfort, All day comfort, same comfort at the end of the day (EOD), comfortable after the end of 4 weeks, Same comfort at 4 weeks as initial, comfortable in dry environments, help focus effortlessly while using digital devices, help with end of day (EOD) dryness, help eyes feel less tired at EOD (including computer or digital device use), offering clear vision during driving.
Lens Wettability
Time frame: Baseline, 1 month
Lens wettability for fanfilcon A and lotrafilcon B lens. (Scale 0-4, 0.25 steps, 0=excellent, 4=severely reduced)
Surface Deposits
Time frame: Baseline, 1 month
Surface deposits for fanfilcon A and lotrafilcon B lens. (Scale 0-4, 0.25 steps, 0=excellent, 4=severely reduced)

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
Fanfilcon A Then Lotrafilcon B	25	24
Lotrafilcon B Then Fanfilcon A	24	23

Primary outcome: Subjective Comfort

Time frame: Baseline, 1 month. Median (Standard Deviation). Unit: units on a scale

Measure	Fanfilcon A n = 47	Lotrafilcon B n = 47
Baseline - Comfort at Insertion	10 (0.93)	9 (1.83)
1 Month - Comfort when lenses are first put in	10 (1.26)	9 (1.44)
1 Month - Comfort during the day's wear	9 (1.32)	8 (1.53)
1 Month - Comfort just prior to lens removal	8 (1.78)	7 (2.14)

Primary outcome: Subjective Preference

Time frame: 1 month. Number. Unit: percentage of participants

Measure	Strongly Prefer Fanfilcon A n = 47	Slightly Prefer Fanfilcon A n = 47	No Preference n = 47	Slightly Prefer Lotrafilcon B n = 47	Strongly Prefer Lotrafilcon B n = 47
Comfort	52	16	9	16	7
Dryness	43	23	11	14	9
Clear vision	38.64	25.0	29.55	4.55	2.27
Lens Handling	9	16	52	23	0
Digital devices	27.27	27.27	40.91	2.27	2.27
All day natural comfort	45	20	14	14	7
All day comfort	27	39	11	18	5
Same comfort at EOD	41	25	11	14	9

Primary outcome: Lens Wettability

Time frame: Baseline, 1 month. Mean (Standard Deviation). Unit: units on a scale

Measure	Fanfilcon A n = 47	Lotrafilcon B n = 47
Baseline	0.76 (0.61)	0.56 (0.46)
1 month	0.85 (0.71)	1.08 (0.71)

Population analysed: One participant excluded from analysis at 1 month.

Primary outcome: Surface Deposits

Time frame: Baseline, 1 month. Mean (Standard Deviation). Unit: units on a scale

Measure	Fanfilcon A n = 47	Lotrafilcon B n = 47
Baseline	0.14 (0.22)	0.26 (0.26)
1 Month	0.34 (0.45)	0.41 (0.56)

Population analysed: One participant excluded from analysis at 1 month.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fanfilcon A	0 of 49 (0%)	0 of 49 (0%)	Not reported
Lotrafilcon B	0 of 49 (0%)	0 of 49 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Myopia

Recruiting
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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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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.

Lyndon Jones principal investigator

Director, Centre for Contact Lens Research

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 and lotrafilcon B in people with Myopia, run by CooperVision, Inc. at 1 site in Canada.

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 7 inclusion and 11 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 30 May 2017. 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 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 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?

Subjective Comfort (time frame: Baseline, 1 month). 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 NCT02716298.

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 30 May 2017.