AstigmatismNCT03519932

Comparison of Comfilcon A Toric Contact Lenses and Samfilcon A Toric Contact Lenses

A study testing comfilcon A toric lens and samfilcon A toric lens in people with Astigmatism, 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.

Official record

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Trial summary

The objective of this study is to evaluate the subjective acceptance of comfilcon A toric contact lens, compared to samfilcon A toric lens. Read more about this study

Who is it for?: Ages 17 years and older
Conditions the study is for: Astigmatism
What is being tested?: comfilcon A toric lens and samfilcon A toric lens
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: 30 Apr 2018to 1 Feb 2019
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

Is at least 17 years of age and has full legal capacity to volunteer;
Has had a self-reported oculo-visual examination in the last two years.
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Is an adapted soft contact lens wearer, who currently wears contact lenses for a minimum 3 days/week and 8 hours/day AND who anticipates no difficulty wearing CLs for 6 days/week, 10 hours /day.
Is willing to wear contact lens in both eyes for the duration of the study;

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Has a minimum astigmatism of - 0.75, determined by refraction;
Can be fit with the two study contact lens types in the powers available;
Has a distance visual acuity of 0.20 logMAR (approx 20/30) or better, determined by refraction;
Can achieve a distance visual acuity of 0.20 logMAR (approx 20/30) or better in each eye with the study contact lenses.
Has clear corneas and no active* ocular disease

Who cannot join

Is participating in any concurrent clinical trial;
Has any known active* ocular disease and/or infection;
Has a systemic condition that in the opinion of the investigator may affect a study measure;
Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure;
Has known sensitivity to fluorescein dye or products to be used in the study;
Appears to have any active* ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses;

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Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
Is aphakic;
Has undergone refractive error surgery.
Has participated in the PIANO (i.e. EX-MKTG-83) Study.

Trial locations and contacts

1 site in 1 country.

Canada1 site

University of Waterloo
Waterloo, Ontario, N2L 3G1

Other trials in Canada

About this study

Official title: A Bilateral Dispensing Comparison of Biofinity Toric and Ultra for Astigmatism

The objective of this study is to evaluate the subjective acceptance of comfilcon A toric contact lens, compared to samfilcon A toric lens.

Conditions: Astigmatism
Being tested: comfilcon A toric lens, samfilcon A toric lens
Medical subject headings: Astigmatism

What participants receive

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

comfilcon A toric lensDevice
Also called Biofinity toric, test lens
Contact lens
samfilcon A toric lensDevice
Also called Ultra for Astigmatism, control lens
Contact lens

Study groups in NCT03519932
Study group	Role	What they receive
comfilcon A toric lens	Experimental	Subjects who wear comfilcon A toric lens either as first or second pair during this cross-over study. Receives: Device: comfilcon A toric lens; Device: samfilcon A toric lens
samfilcon A toric lens	Active comparator	Subjects who wear samfilcon A toric lens either as first or second pair during this cross-over study. Receives: Device: comfilcon A toric lens; Device: samfilcon A toric lens

What is being measured

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

Comfort at Insertion
Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)
Measured: Dispense
Comfort
Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)
Measured: 2 weeks
Comfort
Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)
Measured: 1-month
Lens Preference Based on Overall Comfort
Lens preference with respect to comfort (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)
Measured: 1 month
Lens Preference Based on Overall Dryness
Lens preference with respect to dryness (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)
Measured: 1 month
Dryness
Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness)
Measured: 2 weeks
Dryness
Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness)
Measured: 1-month

Secondary outcomes (5)

Ease of Insertion
Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)
Measured: Dispense
Ease of Insertion
Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)
Measured: 2-weeks
Ease of Insertion
Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)
Measured: 1-month
Ease of Removal
Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy)
Measured: 2-weeks
Ease of Removal
Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy)
Measured: 1 month

Timeline

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

30 Apr 20181 Feb 2019

First posted9 May 2018
Study start30 Apr 2018
Primary completion15 Oct 2018
Study completion1 Feb 2019

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: Double blind
Who is masked: Participant, Investigator
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03519932
Sponsor's protocol ID: EX-MKTG-91
Status last verified: Dec 2019
First submitted: 1 May 2018
Last updated: 6 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
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

Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Not yet recruiting
The EYERISING Study
Myopia, Astigmatism
Active, not recruiting
P1 Toric Vs. Max 1day
Eye, Astigmatism
Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
Astigmatism, Myopia
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism

All Astigmatism trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Bilateral Dispensing Comparison of Biofinity Toric and Ultra for Astigmatism
ClinicalTrials.gov ID: NCT03519932
Acronym / sponsor ID: EX-MKTG-91
Conditions: Astigmatism
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 30 Apr 2018 (actual)
Primary completion: 15 Oct 2018 (actual)
Study completion: 1 Feb 2019 (actual)
First posted: 9 May 2018 (actual)
Results: Posted 6 Jan 2020

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 this study is to evaluate the subjective acceptance of comfilcon A toric contact lens, compared to samfilcon A toric lens.

Study design

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

Arm	Type	Receives
comfilcon A toric lens	Experimental	Device: comfilcon A toric lens, Device: samfilcon A toric lensSubjects who wear comfilcon A toric lens either as first or second pair during this cross-over study.
samfilcon A toric lens	Active comparator	Device: comfilcon A toric lens, Device: samfilcon A toric lensSubjects who wear samfilcon A toric lens either as first or second pair during this cross-over study.

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)

Is at least 17 years of age and has full legal capacity to volunteer;
Has had a self-reported oculo-visual examination in the last two years.
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Is an adapted soft contact lens wearer, who currently wears contact lenses for a minimum 3 days/week and 8 hours/day AND who anticipates no difficulty wearing CLs for 6 days/week, 10 hours /day.

Key exclusion criteria (10 listed)

Is participating in any concurrent clinical trial;
Has any known active* ocular disease and/or infection;
Has a systemic condition that in the opinion of the investigator may affect a study measure;
Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure;
Has known sensitivity to fluorescein dye or products 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
comfilcon A toric lensAlso: Biofinity toric, test lensContact lens	Device	comfilcon A toric lens, samfilcon A toric lens
samfilcon A toric lensAlso: Ultra for Astigmatism, control lensContact lens	Device	comfilcon A toric lens, samfilcon A toric lens

Primary outcome

Comfort at Insertion
Time frame: Dispense
Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)
Comfort
Time frame: 2 weeks
Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)
Comfort
Time frame: 1-month
Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)
Lens Preference Based on Overall Comfort
Time frame: 1 month
Lens preference with respect to comfort (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)
Lens Preference Based on Overall Dryness
Time frame: 1 month
Lens preference with respect to dryness (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)
Dryness
Time frame: 2 weeks
Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness)
Dryness
Time frame: 1-month
Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness)

5 secondary outcomes

Ease of Insertion
Time frame: Dispense
Ease of Insertion
Time frame: 2-weeks
Ease of Insertion
Time frame: 1-month
Ease of Removal
Time frame: 2-weeks
Ease of Removal
Time frame: 1 month

Results and safety

Results posted to the registry on 6 Jan 2020, 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 Toric Then Samfilcon A Toric	24	23
Samfilcon A Toric Then Comfilcon A Toric	25	22

Primary outcome: Comfort at Insertion

Time frame: Dispense. Mean (Standard Deviation). Unit: units on a scale

Measure	Comfilcon A Toric Lens n = 45	Samfilcon A Toric Lens n = 45
Value	9.0 (1.2)	8.8 (1.2)

Primary outcome: Comfort

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

Measure	Comfilcon A Toric Lens n = 44	Samfilcon A Toric Lens n = 45
Overall	8.1 (1.4)	7.4 (2.1)
Removal	7.2 (2.1)	6.5 (2.4)

Population analysed: One subject's subjective rating was excluded for comfilcon A toric due to subject confusion at rating scale and potentially reversing its use.

Primary outcome: Comfort

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

Measure	Comfilcon A Toric Lens n = 45	Samfilcon A Toric Lens n = 44
Overall	8.1 (1.6)	7.4 (2.1)
Removal	7.1 (2.1)	6.7 (2.5)

Primary outcome: Lens Preference Based on Overall Comfort

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

Measure	Overall Preference n = 45
Strongly prefer comfilcon A	44
Slightly Prefer comfilcon A	27
No Preference	7
Slightly prefer samfilcon A	7
Strongly prefer samfilcon A	16

Population analysed: Percentages may be rounded and therefore may not add up to equal to 100%

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: One month during each crossover period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Comfilcon A Toric	0 of 45 (0%)	0 of 45 (0%)	0 of 45
Samfilcon A Toric	0 of 45 (0%)	0 of 45 (0%)	0 of 45

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Astigmatism

Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Not yet recruiting
The EYERISING Study
Myopia, Astigmatism
Active, not recruiting
P1 Toric Vs. Max 1day
Eye, Astigmatism
Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
Astigmatism, Myopia
Recruiting
Clareon TruPlus Study
Aphakia, 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

Director, Centre for Ocular Research & Education

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

Questions about this trial

What is this clinical trial studying?

A study testing comfilcon A toric lens and samfilcon A toric lens in people with Astigmatism, 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 11 inclusion and 10 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 6 Jan 2020. 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 6 Jan 2020). 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 at Insertion (time frame: Dispense). The study lists 7 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 NCT03519932.

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 6 Jan 2020.