MyopiaNCT02588573

Overall Performance of a 1-day Silicone Hydrogel Lens When Habitual Soft Lens Wearers Are Refit

A study testing somofilcon A (test) in people with Myopia, run by CooperVision, Inc. at 2 sites 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 compare the overall subjective comfort profile over 8 hours of lens wear in two groups of habitual soft contact lens wearers (daily disposable hydrogel lenses and frequent replacement lenses) when refitted in to somofilcon A lenses. 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 (test)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 103 participants
Where: 2 sitesCanada
Study dates: Oct 2015to Apr 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
Healthy volunteers accepted
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 20/40 or better (in each eye) with their habitual correction or the assigned study lenses;
Habitually wears either etafilcon A lens or any frequent replacement contact lenses (as defined in 4.1.1);

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Habitually wear contact lenses with a power between -1.00 and -6.00D (Diopters) (inclusive) in both eyes;
Demonstrates an acceptable fit with the study lenses;
Is usually able to wear contact lenses for at least 8 hours per day.

Who cannot join

A person will be excluded from the study if he/she:
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 substances (pharmaceuticals), such as fluorescein dye, or products to be used in the study;

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Is aphakic;
Has undergone refractive error surgery.
Has participated in the previous somfofilcon A study (ORE# 20893)
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

2 sites in 1 country.

Canada2 sites

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

Other trials in Canada

About this study

Read the detailed description

This will be a prospective, single day, randomized, double-masked, non-dispensing, contralateral study. Participants were recruited into one of two groups - participants who habitually wore etafilcon A: daily disposable hydrogel lenses and participants who habitually wore frequent replacement lenses (FREQ).

Conditions: Myopia
Being tested: etafilcon A (control), somofilcon A (test)
Medical subject headings: Myopia

What participants receive

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

etafilcon A (control)Device
contact lens
somofilcon A (test)Device
contact lens

Study groups in NCT02588573
Study group	Role	What they receive
Etafilcon A (control)	Active comparator	Subjects in each of the habitual wearing groups will be randomized to wear either the test or control lens in either the left or right eye. Receives: Device: etafilcon A (control); Device: somofilcon A (test)
Somofilcon A (test)	Active comparator	Subjects in each of the habitual wearing groups will be randomized to wear either the test or control lens in either the left or right eye. Receives: Device: etafilcon A (control); Device: somofilcon A (test)

What is being measured

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

Comfort
Subjective ratings for lens comfort of etafilcon A and somofilcon A. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever.
Measured: 8 hours
Comfort Preference
Lens preference in regards to comfort of etafilcon A and somofilcon A. Categories: Strongly prefer etafilcon A lens, slightly prefer etafilcon A lens, no preference, slightly prefer somofilcon A lens, strongly prefer somofilcon A lens
Measured: Baseline and 8 hours
Bulbar Hyperemia
Bulbar hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe.
Measured: Baseline and 8 hours
Limbal Hyperemia
Limbal hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe.
Measured: Baseline and 8 hours
Conjunctival Staining
Conjunctival staining was graded in each quadrant with scale 0-4, 0.5 steps, 0=normal, 4=severe of four areas:
N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central
Measured: 8 hours
Visual Acuity
High contrast visual acuity at high illumination was measured with each lens at each visit using a logMAR chart.
Measured: Baseline and 8 hours

Timeline

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

Oct 2015Apr 2016

First posted28 Oct 2015 (estimated)
Study startOct 2015
Primary completionMar 2016
Study completionApr 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: Single group
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 103 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02588573
Sponsor's protocol ID: EX-MKTG-61
Status last verified: Feb 2019
First submitted: 22 Oct 2015
Last updated: 8 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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
Myopia, Myopia Progressing
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 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Overall Performance of a 1-day Silicone Hydrogel Lens When Habitual Soft Lens Wearers Are Refit
ClinicalTrials.gov ID: NCT02588573
Acronym / sponsor ID: EX-MKTG-61
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 103 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2015
Primary completion: Mar 2016 (actual)
Study completion: Apr 2016 (actual)
First posted: 28 Oct 2015 (estimated)
Results: Posted 8 Feb 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: Single group
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Etafilcon A (control)	Active comparator	Device: etafilcon A (control), Device: somofilcon A (test)Subjects in each of the habitual wearing groups will be randomized to wear either the test or control lens in either the left or right eye.
Somofilcon A (test)	Active comparator	Device: etafilcon A (control), Device: somofilcon A (test)Subjects in each of the habitual wearing groups will be randomized to wear either the test or control lens in either the left or right eye.

Who may qualify

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

Key inclusion criteria (9 listed)

A person is eligible for inclusion in the study if he/she:

Key exclusion criteria (10 listed)

A person will be excluded from the study if he/she:

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
etafilcon A (control)contact lens	Device	Etafilcon A (control), Somofilcon A (test)
somofilcon A (test)contact lens	Device	Etafilcon A (control), Somofilcon A (test)

Primary outcome

Comfort
Time frame: 8 hours
Subjective ratings for lens comfort of etafilcon A and somofilcon A. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever.
Comfort Preference
Time frame: Baseline and 8 hours
Lens preference in regards to comfort of etafilcon A and somofilcon A. Categories: Strongly prefer etafilcon A lens, slightly prefer etafilcon A lens, no preference, slightly prefer somofilcon A lens, strongly prefer somofilcon A lens
Bulbar Hyperemia
Time frame: Baseline and 8 hours
Bulbar hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe.
Limbal Hyperemia
Time frame: Baseline and 8 hours
Limbal hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe.
Conjunctival Staining
Time frame: 8 hours
Conjunctival staining was graded in each quadrant with scale 0-4, 0.5 steps, 0=normal, 4=severe of four areas: N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central
Visual Acuity
Time frame: Baseline and 8 hours
High contrast visual acuity at high illumination was measured with each lens at each visit using a logMAR chart.

Results and safety

Results posted to the registry on 8 Feb 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
Habitual Etafilcon A Wearers	45	45
Habitual FREQ Wearers	45	45

Primary outcome: Comfort

Time frame: 8 hours. Mean (Standard Deviation). Unit: units on a scale

Measure	Habitual Etafilcon A Wearers Randomized to Etafilcon A n = 45	Habitual Etafilcon A Wearers Randomized to Somofilcon A n = 45	Habitual FREQ Wearers Randomized to Etafilcon A n = 45	Habitual FREQ Wearers Randomized to Somofilcon A n = 45
Value	83 (17)	77 (22)	83 (14)	83 (16)

Primary outcome: Comfort Preference

Time frame: Baseline and 8 hours. Number. Unit: participants

Measure	Habitual Etafilcon A Wearers - Baseline n = 45	Habitual FREQ Wearers - Baseline n = 45	Habitual Etafilcon A Wearers - 8hrs n = 45	Habitual FREQ Wearers - 8hrs n = 45
Strongly Prefer Etafilcon A Lens	7	3	13	2
Slightly Prefer Etafilcon A Lens	14	10	11	16
No Preference	12	19	5	10
Slightly Prefer Somofilcon A Lens	10	11	9	8
Strongly Prefer Somofilcon A Lens	2	2	7	9

Primary outcome: Bulbar Hyperemia

Time frame: Baseline and 8 hours. Mean (Standard Deviation). Unit: units on a scale

Measure	Habitual Etafilcon A Wearers Randomized to Etafilcon A n = 45	Habitual Etafilcon A Wearers Randomized to Somofilcon A n = 45	Habitual FREQ Wearers Randomized to Etafilcon A n = 45	Habitual FREQ Wearers Randomized to Somofilcon A n = 45
Baseline	1.3 (0.4)	1.3 (0.4)	1.2 (0.4)	1.2 (0.4)
8 hours	1.3 (0.4)	1.3 (0.4)	1.2 (0.4)	1.2 (0.4)

Primary outcome: Limbal Hyperemia

Time frame: Baseline and 8 hours. Mean (Standard Deviation). Unit: units on a scale

Measure	Habitual Etafilcon A Wearers Randomized to Etafilcon A n = 45	Habitual Etafilcon A Wearers Randomized to Somofilcon A n = 45	Habitual FREQ Wearers Randomized to Etafilcon A n = 45	Habitual FREQ Wearers Randomized to Somofilcon A n = 45
Baseline	1.2 (0.5)	1.2 (0.5)	1.0 (0.4)	1.0 (0.4)
8 hours	1.2 (0.4)	1.3 (0.4)	1.4 (0.5)	1.3 (0.4)

Adverse events

Time frame: 8 hours. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Etafilcon A Lens (Control) Worn by Habitual Etafilcon A Grp	0 of 45 (0%)	0 of 45 (0%)	Not reported
Somofilcon A Lens (Test) Worn by Habitual Etafilcon A Grp	0 of 45 (0%)	0 of 45 (0%)	Not reported
Etafilcon A Lens (Control) Worn by Habitual FREQ Grp	0 of 45 (0%)	0 of 45 (0%)	Not reported
Somofilcon A Lens (Test) Worn by Habitual FREQ Grp	0 of 45 (0%)	0 of 45 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
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
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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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Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
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Active, not recruiting
Effect of IOP Lowering on Progressive HM
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Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
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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, PhD, FCOptom principal investigator

Centre for Contact Lens Research

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

Questions about this trial

What is this clinical trial studying?

A study testing somofilcon A (test) in people with Myopia, run by CooperVision, Inc. at 2 sites 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 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 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 8 Feb 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: 8 hours). 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 NCT02588573.

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 8 Feb 2019.