MyopiaNCT03372551

Comparison of Somofilcon A Daily Disposable Test Contact Lens and Somofilcon A Daily Disposable Control Contact Lens

A study testing somofilcon A 1 day test lens 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

The purpose of this study is to investigate the overall clinical performance of the somofilcon A daily disposable test soft contact lens compared to the somofilcon A daily disposable control soft contact 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?: somofilcon A 1 day test lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteCanada
Study dates: 29 Nov 2017to 23 Apr 2018
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, understood, and signed the information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Has a visual acuity of 20/30 or better (in each eye) with their habitual vision correction, or 20/20 best-corrected vision (for binocular distance acuity);
Must be able to achieve 20/30 or better (in each eye) with the study lenses;

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Currently wears soft contact lenses for at least 3 days per week, 8 hours each day;
Requires spectacle lens powers between -0.75 and -06.50 diopters sphere (0.25D steps);
Has no more than 0.75 diopters of refractive astigmatism;
Has clear corneas and no active* ocular disease;
Has not worn lenses for at least 12 hours before the examination.

Who cannot join

Is presently participating in any other clinical or research study including eye related clinical or research study;
Has never worn contact lenses before.
Has any systemic disease affecting ocular health.
Has any active* ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
Is using any systemic or topical medications that will affect a study outcome variable, and/or ocular health.
Has any known sensitivity to fluorescein dye or products to be used in the study.

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Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
Is aphakic.
Has undergone corneal refractive surgery.
Is pregnant, lactating, or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).

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

Official title: Comparison of Daily Disposable Invigor I (Test) and Select 1 Day Lenses

Read the detailed description

The purpose of this study is to evaluate the clinical performance of an investigational silicone-hydrogel contact lens (test) against a marketed silicone-hydrogel contact lens (control) when worn on a daily disposable wear modality over 1 week (for each lens) in a randomized, bilateral, cross-over, dispensing study.

Conditions: Myopia
Being tested: somofilcon A 1 day test lens, somofilcon A 1 day control lens
Medical subject headings: Myopia

What participants receive

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

somofilcon A 1 day test lensDevice
Also called somofilcon A daily disposable test soft contact lens, Invigor I, Test lens
Contact lens
somofilcon A 1 day control lensDevice
Also called somofilcon A daily disposable control soft contact lens, Select 1-Day, Control lens
Contact lens

Study groups in NCT03372551
Study group	Role	What they receive
somofilcon A 1 day test lens	Experimental	Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair. Receives: Device: somofilcon A 1 day test lens; Device: somofilcon A 1 day control lens
somofilcon A 1 day control lens	Active comparator	Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair. Receives: Device: somofilcon A 1 day test lens; Device: somofilcon A 1 day control lens

What is being measured

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

Comfort
Subjective comfort scored 0-100 (0=Cannot be worn, 100=Cannot be felt ever)
Measured: up to 1 week
Preference
Overall lens that subject prefers or no preference
Measured: up to 1 week
Vision
Visual acuity measured in logMAR
Measured: Up to 1 week
Subjective Vision
Subjective vision scored 0-100 (0=Extremely poor, 100=Excellent vision all the time)
Measured: up to 1 week
Corneal Staining
Amount of staining observed on the cornea scored 0-4 (0=none, 4=severe) in 0.25 steps
Measured: up to 1 week
Conjunctival Staining
Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=severe) in 0.25 steps
Measured: up to 1 week

Timeline

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

29 Nov 201723 Apr 2018

First posted13 Dec 2017
Study start29 Nov 2017
Primary completion22 Dec 2017
Study completion23 Apr 2018

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
Model description: This will be a, prospective, double-masked, randomized, bilateral, 1 week cross-over, dispensing study
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03372551
Sponsor's protocol ID: CV-16-43
Status last verified: Jul 2019
First submitted: 8 Dec 2017
Last updated: 23 Jul 2019
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

Recruiting
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Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
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Active, not recruiting
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Recruiting
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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Daily Disposable Invigor I (Test) and Select 1 Day Lenses
ClinicalTrials.gov ID: NCT03372551
Acronym / sponsor ID: CV-16-43
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 29 Nov 2017 (actual)
Primary completion: 22 Dec 2017 (actual)
Study completion: 23 Apr 2018 (actual)
First posted: 13 Dec 2017 (actual)
Results: Posted 29 May 2019

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: This will be a, prospective, double-masked, randomized, bilateral, 1 week cross-over, dispensing study

Arm	Type	Receives
somofilcon A 1 day test lens	Experimental	Device: somofilcon A 1 day test lens, Device: somofilcon A 1 day control lensSubjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair.
somofilcon A 1 day control lens	Active comparator	Device: somofilcon A 1 day test lens, Device: somofilcon A 1 day control lensSubjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second 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)

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, understood, and signed the information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Has a visual acuity of 20/30 or better (in each eye) with their habitual vision correction, or 20/20 best-corrected vision (for binocular distance acuity);

Key exclusion criteria (11 listed)

Is presently participating in any other clinical or research study including eye related clinical or research study;
Has never worn contact lenses before.
Has any systemic disease affecting ocular health.
Has any active* ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
Is using any systemic or topical medications that will affect a study outcome variable, and/or ocular health.

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
somofilcon A 1 day test lensAlso: somofilcon A daily disposable test soft contact lens, Invigor I, Test lensContact lens	Device	somofilcon A 1 day control lens, somofilcon A 1 day test lens
somofilcon A 1 day control lensAlso: somofilcon A daily disposable control soft contact lens, Select 1-Day, Control lensContact lens	Device	somofilcon A 1 day control lens, somofilcon A 1 day test lens

Primary outcome

Comfort
Time frame: up to 1 week
Subjective comfort scored 0-100 (0=Cannot be worn, 100=Cannot be felt ever)
Preference
Time frame: up to 1 week
Overall lens that subject prefers or no preference
Vision
Time frame: Up to 1 week
Visual acuity measured in logMAR
Subjective Vision
Time frame: up to 1 week
Subjective vision scored 0-100 (0=Extremely poor, 100=Excellent vision all the time)
Corneal Staining
Time frame: up to 1 week
Amount of staining observed on the cornea scored 0-4 (0=none, 4=severe) in 0.25 steps
Conjunctival Staining
Time frame: up to 1 week
Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=severe) in 0.25 steps

Results and safety

Results posted to the registry on 29 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Somofilcon A 1 Day Test Lens First, Then Control 1 Day Lens	17	16
Somofilcon A 1 Day Control Lens First, Then 1 Day Test Lens	16	16

Primary outcome: Comfort

Time frame: up to 1 week. Mean (Standard Deviation). Unit: score on a scale

Measure	Somofilcon A 1 Day Test Lens n = 32	Somofilcon A 1 Day Control Lens n = 32
Comfort at Dispense	90 (8)	89 (11)
Comfort at Insertion after 1 week	86 (11)	87 (16)
Comfort during day after 1 week	84 (11)	86 (11)
Comfort end day after 1 week	75 (15)	78 (16)
Overall comfort after 1 week of lens wear	82 (11)	85 (12)

Primary outcome: Preference

Time frame: up to 1 week. Count of participants. Unit: Participants

Measure	Somofilcon A 1 Day Test / Control Contact Lens n = 32
Strongly preferred somofilcon A 1 Day Test lens	5
Slightly preferred somofilcon A 1 Day Test lens	9
No preference	1
Slightly preferred somofilcon A 1 Day Control lens	5
Strongly preferred somofilcon A 1 Day control lens	12

Primary outcome: Vision

Time frame: Up to 1 week. Mean (Standard Deviation). Unit: Log(MAR)

Measure	Somofilcon A 1 Day Test Lens Dispense n = 32	Somofilcon A 1 Day Test Lens 1 Week n = 31	Somofilcon A 1 Day Control Lens Dispense n = 32	Somofilcon A 1 Day Control Lens 1 Week n = 31
High Illumination high contrast monocular	-0.10 (0.07)	-0.10 (0.07)	-0.11 (0.07)	-0.11 (0.06)
High Illumination high contrast binocular	-0.15 (0.06)	-0.15 (0.07)	-0.15 (0.06)	-0.16 (0.06)
Low Illumination high contrast monocular	-0.08 (0.05)	-0.07 (0.07)	-0.09 (0.07)	-0.10 (0.06)
Low Illumination high contrast binocular	-0.13 (0.06)	-0.13 (0.07)	-0.13 (0.06)	-0.14 (0.05)

Population analysed: Dispensing - n=32 participants total, 1 week = 31 participants total due to a nonserious adverse events for somofilcon A 1 day test lens.

Primary outcome: Subjective Vision

Time frame: up to 1 week. Mean (Standard Deviation). Unit: score on a scale

Measure	Somofilcon 1 Day Test Lens: Vision Quality/Clarity During Day n = 32	Somofilcon A Control Lens: Vision Quality/Clarity During Day n = 32
Dispense	92 (9)	92 (6)
1 week	88 (12)	91 (11)

Adverse events

Time frame: From dispense to completion of follow up, up to 2 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Somofilcon A 1 Day Test Lens	0 of 32 (0%)	0 of 32 (0%)	0 of 32
Somofilcon A 1 Day Control Lens	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 23 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A study testing somofilcon A 1 day test lens 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 11 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 23 Jul 2019. 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 29 May 2019). 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 (time frame: up to 1 week). The study lists 6 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 NCT03372551.

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 23 Jul 2019.