MyopiaNCT04195893

Refitting Frequent Replacement Lens Wearers Into Clariti 1 Day And 1-Day Acuvue Moist Daily Disposable Spherical Lenses

A study testing somofilcon A and etafilcon A 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 objective of the study is to evaluate and compare the performance of somofilcon A to etafilcon A when worn on a daily disposable wear modality over a period of approximately one week. Read more about this study

Who is it for?: Ages 17 years and olderHealthy volunteers can take part
Conditions the study is for: Myopia
What is being tested?: somofilcon A and etafilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: 1 siteCanada
Study dates: 24 Nov 2019to 11 Mar 2020
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

Subjects will only be eligible for the study if:
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;
Habitually wears silicone hydrogel frequent replacement soft contact lenses, for minimum of 6-months;
Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses;

Show all 9Show fewer

Can be fit with study contact lenses with a power between - 0.50 and -10.00 DS;
Demonstrates an acceptable fit with the study lenses;
Habitually wears contact lenses for at least 8 hours per day, and willing to wear contact lenses for at least 12 hours a day in the study.

Who cannot join

Subjects will not be eligible to take part in the study if:
Is participating in any concurrent clinical or research study;
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;
Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;

Show all 11Show fewer

Is pregnant, lactating or planning a pregnancy at the time of enrolment (verbal confirmation at the screening visit);
Is aphakic;
Has undergone refractive error surgery;
Is an employee of the Centre for Ocular Research \& Education;
Has participated in the BEAGLE (EX-MKTG-104) 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: Refitting Frequent Replacement Lens Wearers Into Clariti 1 Day And 1-Day Acuvue Moist Daily Disposable Spherical Lenses (BEAGLE 2)

The objective of the study is to evaluate and compare the performance of somofilcon A to etafilcon A when worn on a daily disposable wear modality over a period of approximately one week.

Read the detailed description

The study is a prospective, double masked (investigator and participant), bilateral, randomized, cross-over dispensing study, which evaluates somofilcon A (test lens) and etafilcon A (control lens).

Conditions: Myopia
Being tested: somofilcon A, etafilcon A
Medical subject headings: Myopia

What participants receive

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

somofilcon ADevice
Also called Clariti 1-Day
Contact Lens
etafilcon ADevice
Also called 1-Day Acuvue Moist
Contact Lens

Study groups in NCT04195893
Study group	Role	What they receive
somofilcon A	Experimental	Subjects will be randomized to wear somofilcon A daily disposable lenses for one week and then switch to etafilcon A daily disposable lenses for one week. Receives: Device: somofilcon A
etafilcon A	Active comparator	Subjects will be randomized to wear etafilcon A daily disposable lenses for one week and then switch to somofilcon A daily disposable lenses for one week. Receives: Device: etafilcon A

What is being measured

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

Lens Handling for Lens Insertion
Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Measured: Day 1
Lens Handling for Lens Insertion
Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Measured: Day 3
Lens Handling for Lens Insertion
Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Measured: Day 5
Lens Handling for Lens Insertion
Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Measured: 1 Week
Lens Handling for Lens Removal
Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Measured: Day 1
Lens Handling for Lens Removal
Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Measured: Day 3
Lens Handling for Lens Removal
Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Measured: Day 5
Lens Handling for Lens Removal
Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Measured: 1 week

Secondary outcomes (6)

Lens Centration
Lens Centration was measured on a scale of 0-3 (0 - optimal, 1 - slight decentration, 2- moderate decentration but not encroaching limbus, 3 - excessive \& occasionally encroaching limbus)
Measured: Baseline (after 10 minutes of lens fitting)
Lens Centration
Lens Centration was measured on a scale of 0 - 3 (0-optimal, 1-slight decentration, 2-moderate decentration but not encroaching limbus, 3-excessive \& occasionally encroaching limbus)
Measured: 1 week
Post-blink Movement
Post-blink movement in primary gaze, in 0.1mm steps
Measured: Baseline (after 10 minutes of lens fitting)
Post-blink Movement
Post-blink movement in primary gaze, in 0.1mm steps
Measured: 1 -week
Push-up Tightness
Push-up tightness in primary gaze was measured using a scale 0-100 (5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement)
Measured: Baseline (after 10 minutes of lens fitting)
Push-up Tightness
Push-up tightness in primary gaze was measured using a scale 0-100 (5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement)
Measured: 1 week

Timeline

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

24 Nov 201911 Mar 2020

First posted12 Dec 2019
Study start24 Nov 2019
Primary completion12 Feb 2020
Study completion11 Mar 2020

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: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04195893
Sponsor's protocol ID: EX-MKTG-112
Status last verified: Aug 2020
First submitted: 10 Dec 2019
Last updated: 18 Aug 2020
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
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

All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Refitting Frequent Replacement Lens Wearers Into Clariti 1 Day And 1-Day Acuvue Moist Daily Disposable Spherical Lenses (BEAGLE 2)
ClinicalTrials.gov ID: NCT04195893
Acronym / sponsor ID: EX-MKTG-112
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 24 Nov 2019 (actual)
Primary completion: 12 Feb 2020 (actual)
Study completion: 11 Mar 2020 (actual)
First posted: 12 Dec 2019 (actual)
Results: Posted 3 Aug 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 the study is to evaluate and compare the performance of somofilcon A to etafilcon A when worn on a daily disposable wear modality over a period of approximately one week.

Detailed description

The study is a prospective, double masked (investigator and participant), bilateral, randomized, cross-over dispensing study, which evaluates somofilcon A (test lens) and etafilcon A (control lens).

Study design

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

Arm	Type	Receives
somofilcon A	Experimental	Device: somofilcon ASubjects will be randomized to wear somofilcon A daily disposable lenses for one week and then switch to etafilcon A daily disposable lenses for one week.
etafilcon A	Active comparator	Device: etafilcon ASubjects will be randomized to wear etafilcon A daily disposable lenses for one week and then switch to somofilcon A daily disposable lenses for one week.

Who may qualify

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

Key inclusion criteria (9 listed)

Subjects will only be eligible for the study if:

Key exclusion criteria (11 listed)

Subjects will not be eligible to take part in the study if:

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 AAlso: Clariti 1-DayContact Lens	Device	somofilcon A
etafilcon AAlso: 1-Day Acuvue MoistContact Lens	Device	etafilcon A

Primary outcome

Lens Handling for Lens Insertion
Time frame: Day 1
Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Lens Handling for Lens Insertion
Time frame: Day 3
Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Lens Handling for Lens Insertion
Time frame: Day 5
Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Lens Handling for Lens Insertion
Time frame: 1 Week
Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Lens Handling for Lens Removal
Time frame: Day 1
Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Lens Handling for Lens Removal
Time frame: Day 3
Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Lens Handling for Lens Removal
Time frame: Day 5
Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Lens Handling for Lens Removal
Time frame: 1 week
Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)

6 secondary outcomes

Lens Centration
Time frame: Baseline (after 10 minutes of lens fitting)
Lens Centration
Time frame: 1 week
Post-blink Movement
Time frame: Baseline (after 10 minutes of lens fitting)
Post-blink Movement
Time frame: 1 -week
Push-up Tightness
Time frame: Baseline (after 10 minutes of lens fitting)
Push-up Tightness
Time frame: 1 week

Results and safety

Results posted to the registry on 3 Aug 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
Somofilcon A Then Etafilcon A	27	27
Etafilcon A Then Somofilcon A	29	29

Primary outcome: Lens Handling for Lens Insertion

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

Measure	Somofilcon A n = 55	Etafilcon A n = 55
Value	9.3 (1.0)	8.0 (1.9)

Primary outcome: Lens Handling for Lens Insertion

Time frame: Day 3. Mean (Standard Deviation). Unit: units on a scale

Measure	Somofilcon A n = 55	Etafilcon A n = 55
Value	9.3 (1.2)	7.9 (2.4)

Primary outcome: Lens Handling for Lens Insertion

Time frame: Day 5. Mean (Standard Deviation). Unit: units on a scale

Measure	Somofilcon A n = 55	Etafilcon A n = 55
Value	9.2 (1.3)	8.1 (2.3)

Primary outcome: Lens Handling for Lens Insertion

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

Measure	Somofilcon A n = 55	Etafilcon A n = 55
Value	9.4 (0.8)	8.1 (1.7)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline till 1 -week for each type of lenses, up to 2 weeks total. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Somofilcon A	0 of 55 (0%)	2 of 55 (3.6%)	0 of 55
Etafilcon A	0 of 55 (0%)	0 of 55 (0%)	0 of 55

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
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.

Lyndon Jones principal investigator

University of Waterloo

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 and etafilcon A 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 9 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 18 Aug 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 3 Aug 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?

Lens Handling for Lens Insertion (time frame: Day 1). The study lists 8 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 NCT04195893.

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 18 Aug 2020.