AstigmatismNCT04404725

Comparing Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism

A study testing comfilcon A and Samfilcon A in people with Astigmatism and Presbyopia, run by CooperVision, Inc. at 7 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

The objective of the study was to compare the handling and performance of Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism. Read more about this study

Who is it for?: Ages 17 years and olderHealthy volunteers can take part
Conditions the study is for: Astigmatism, Presbyopia
What is being tested?: comfilcon A and Samfilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 7 sitesin 2 countries
Study dates: 6 Aug 2020to 29 Jul 2021
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
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Is at least 42 years of age and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Self reports having a full eye examination in the previous two years;
Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week;
Is willing and able to follow instructions and maintain the appointment schedule;
Habitually wears soft contact lens for the past 3 months minimum;

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Has refractive astigmatism of at least -0.75DC;
Is presbyopic and requires a reading addition of at least +0.75D;
Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (sphere +4 to -6; cylinder -0.75 to -1.75DC; near addition +0.75 to +2.50).

Who cannot join

Is participating in any concurrent clinical or research study;
Habitually wears one of the study contact 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 contact lens wear or a study outcome variable;
Has known sensitivity to the diagnostic sodium fluorescein and/or the care product Opti-Free PureMoist being used in the study;
Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
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

7 sites in 2 countries.

Country

City, postcode or hospital

7 sites in 2 countries

Canada5 sites

Glasses Half Full
Edmonton, Alberta, T5N1S5
Dolman Eyecare Centre
New Hamburg, Ontario, N3A 1K2
Spadina Optometry
Toronto, Ontario, M5V 2K8
Lyndon Jones
Waterloo, Ontorio, N2L 3G1
Oakley Eyecare
Winnipeg, Manitoba, R2C 3B4

Other trials in Canada

United States2 sites

Athens Eye care
Athens, Ohio, 45701
Nittany Eye Associates
State College, Pennsylvania, 16801

Other trials in United States

About this study

The objective of the study was to compare the handling and performance of Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism.

Read the detailed description

The objective of the study was to compare the handling and performance of Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism. This is a prospective, randomized, participant masked, crossover, bilateral dispensing study.

Conditions: Astigmatism, Presbyopia
Being tested: comfilcon A, Samfilcon A
Medical subject headings: Astigmatism, Presbyopia

What participants receive

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

comfilcon ADevice
Also called Biofinity Toric Multifocal
Subjects will be randomized to wear comfilcon A for one month.
Samfilcon ADevice
Also called Ultra Multifocal for Astigmatism
Subjects will be randomized to wear samfilcon A for one month.

Study groups in NCT04404725
Study group	Role	What they receive
comfilcon A then samfilcon A	Experimental	Subjects were randomized to wear comfilcon A for one month then Samfilcon A for one month in this randomized, bilateral cross-over study. Receives: Device: comfilcon A; Device: Samfilcon A
samfilcon A then comfilcon A	Active comparator	Subjects were randomized to wear samfilcon A for one month then comfilcon A for one month in this randomized, bilateral cross-over study. Receives: Device: comfilcon A; Device: Samfilcon A

What is being measured

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

Ease of Lens Handling at Insertion
Subjective at-home ratings for ease of lens handling for insertion, using a 0-10 scale (0-Very difficult, 10 - Very easy).
Measured: Day 28

Timeline

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

6 Aug 202029 Jul 2021

First posted27 May 2020
Study start6 Aug 2020
Primary completion29 Jul 2021
Study completion29 Jul 2021

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 AstigmatismStudies 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: Single blind
Who is masked: Participant
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04404725
Sponsor's protocol ID: EX-MKTG-110
Status last verified: Feb 2022
First submitted: 22 May 2020
Last updated: 3 Mar 2022
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

Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
RecruitingPhase 4
Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
Astigmatism
Recruiting
Evaluation of Orthokeratology Lenses With a 5MM Optic Zone Diameter
Myopia, Astigmatism
Active, not recruiting
Wavelight Plus Sightmap-LASIK vs. Wavefront-Optimized-LASIK
Myopia, Astigmatism

All Astigmatism trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparing Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism
ClinicalTrials.gov ID: NCT04404725
Acronym / sponsor ID: EX-MKTG-110
Conditions: Astigmatism, Presbyopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 6 Aug 2020 (actual)
Primary completion: 29 Jul 2021 (actual)
Study completion: 29 Jul 2021 (actual)
First posted: 27 May 2020 (actual)
Results: Posted 3 Mar 2022

Clinical summary

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

The objective of the study was to compare the handling and performance of Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism.

Detailed description

Study design

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

Arm	Type	Receives
comfilcon A then samfilcon A	Experimental	Device: comfilcon A, Device: Samfilcon ASubjects were randomized to wear comfilcon A for one month then Samfilcon A for one month in this randomized, bilateral cross-over study.
samfilcon A then comfilcon A	Active comparator	Device: comfilcon A, Device: Samfilcon ASubjects were randomized to wear samfilcon A for one month then comfilcon A for one month in this randomized, bilateral cross-over study.

Who may qualify

Ages: 17 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (9 listed)

Is at least 42 years of age and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Self reports having a full eye examination in the previous two years;
Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week;
Is willing and able to follow instructions and maintain the appointment schedule;

Key exclusion criteria (8 listed)

Is participating in any concurrent clinical or research study;
Habitually wears one of the study contact 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 contact lens wear or 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
comfilcon AAlso: Biofinity Toric MultifocalSubjects will be randomized to wear comfilcon A for one month.	Device	comfilcon A then samfilcon A, samfilcon A then comfilcon A
Samfilcon AAlso: Ultra Multifocal for AstigmatismSubjects will be randomized to wear samfilcon A for one month.	Device	comfilcon A then samfilcon A, samfilcon A then comfilcon A

Primary outcome

Ease of Lens Handling at Insertion
Time frame: Day 28
Subjective at-home ratings for ease of lens handling for insertion, using a 0-10 scale (0-Very difficult, 10 - Very easy).

Results and safety

Results posted to the registry on 3 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Comfilcon A Then Samfilcon A	32	32
Samfilcon A Then Comfilcon A	31	29

Primary outcome: Ease of Lens Handling at Insertion

Time frame: Day 28. Mean (Standard Deviation). Unit: score on a scale

Measure	Comfilcon A n = 55	Samfilcon A n = 56
Value	8.6 (1.6)	8.8 (1.8)

Population analysed: Out of 58 subjects who completed the study, data of three participants from the comfilcon A Arm /group and data of two participants from samfilcon A Arm / group was excluded from the analysis due to minor protocol deviations.

Adverse events

Time frame: One month on each study lenses, a total of two months.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Comfilcon A	0 of 61 (0%)	9 of 61 (14.8%)	0 of 61
Samfilcon A	0 of 63 (0%)	9 of 63 (14.3%)	0 of 63

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Astigmatism

Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
RecruitingPhase 4
Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
Astigmatism
Recruiting
Evaluation of Orthokeratology Lenses With a 5MM Optic Zone Diameter
Myopia, Astigmatism
Active, not recruiting
Wavelight Plus Sightmap-LASIK vs. Wavefront-Optimized-LASIK
Myopia, Astigmatism

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, PhD FCOptom principal investigator

University of Waterloo

Fiona Soong principal investigator

Eyes on Sheppard Clinic

Adam Keech principal investigator

Oakley Eyecare

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

Questions about this trial

What is this clinical trial studying?

A study testing comfilcon A and Samfilcon A in people with Astigmatism and Presbyopia, run by CooperVision, Inc. at 7 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 9 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 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Canada, 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 3 Mar 2022). 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?

Ease of Lens Handling at Insertion (time frame: Day 28). 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 NCT04404725.

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 3 Mar 2022.