MyopiaNCT03226353

Performance of Somofilcon A Over One Week in Wearers Adapted to Omafilcon A

A study testing somofilcon A and omafilcon 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 determine if habitual or adapted contact lens wearers of Omafilcon A can be confidently refit into Somofilcon A lenses and be successful after one week of daily wear. The primary outcome variables for this study are: Investigator responses to refit questions; Lens fit. 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 omafilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 77 participants
Where: 1 siteCanada
Study dates: 6 Jul 2017to 27 Sep 2017
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 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 soft spherical contact lenses with a power between +6.00 to -10.00D (inclusive) for a minimum 5 days per week, 10 hours per day and anticipates no difficulty wearing contact lenses for 7 days per week, 10 hours per day;
Habitually wears, or is able to be adequately refit into Proclear 1 Day lenses;
Demonstrates an acceptable fit with Proclear 1 Day and Clariti 1 Day contact lenses;
Is correctable to a visual acuity of 0.20 LogMAR (approximately 20/30) or better (in each eye) with the study lenses or habitual correction;
Manifest cylindrical spectacle refraction does not exceed -1.00DC in either eye.

Who cannot join

Is participating in any concurrent clinical 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;
Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal communication);

Show all 10Show fewer

Is aphakic;
Has undergone refractive error surgery;
Is an employee of the Centre for Contact Lens Research;
Has taken part in another clinical or (pharmaceutical) research study within the last 7 days.

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

The objective of the study is to determine if habitual or adapted contact lens wearers of Omafilcon A can be confidently refit into Somofilcon A lenses and be successful after one week of daily wear.

The primary outcome variables for this study are:

Investigator responses to refit questions;
Lens fit.

Read the detailed description

This is a prospective, single-site, dispensing, bilateral wear, open label, daily wear switch study, with the test lens (Somofilcon A) being worn for 7 (+5) days.

Conditions: Myopia
Being tested: somofilcon A, omafilcon 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
contact lens
omafilcon ADevice
contact lens

Study groups in NCT03226353
Study group	Role	What they receive
somofilcon A 1-day soft contact lenses	Experimental	Habitual and refitted wearers of omafilcon A were refit into somofilcon A for a week Receives: Device: somofilcon A; Device: omafilcon A

What is being measured

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

Investigator Opinion On Overall Patient Refit From Omafilcon A to Somofilcon A: Does Somofilcon A Provides Easy and Quick Refit From Omafilcon A?
Investigator level of agreement using a Likert scale on refitting participants from omafilcon A to somofilcon A at Visit 1 (Strongly Agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree)
Measured: 1 week
Investigator Assessment to Refit- Based on the Investigator Opinion and Lens Fit Outcomes, Would the Investigator Refit the Subject Into Somofilcon A From Omafilcon A?
Investigator level of agreement on the ease of refitting participants from omafilcon A to somofilcon A using Likert scale (Strongly agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree)
Measured: 1 week
Investigator Assessment to Refit - Does Somofilcon A Performs Better Than Omafilcon A Day?
Investigator level of agreement on the ease of refitting participants from omafilcon A to somofilcon A using Likert scale (Strongly agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree)
Measured: 1 week
Investigator Assessment to Refit - Does Somofilcon A Provides an Upgrade From Omafilcon A?
Investigator level of agreement on the ease of refitting participants from omafilcon A to somofilcon A using Likert scale (Strongly agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree)
Measured: 1 week
Lens Fit - Post-blink Lens Movement
Graded on a scale of 0-4, 1 step, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement.
Measured: Dispense and 1 Week
Lens Fit - Lens Tightness
Graded using 0-100 scale (5% steps) where 0 = extremely loose and 100 = extremely tight.
Measured: Dispense and 1 week
Lens Fit - Lens Deposition
Graded on a scale of 0-4, with 0.25 increments, 0=no deposits; 4=deposit ≥ 0.5mm or film >75% surface.
Measured: Dispense and 1 week
Lens Fit - Centration
(3 point scale: optimum, decentration acceptable, decentration unacceptable)
Measured: Dispense and 1 Week
Lens Fit - Lens Wettability
Graded on a scale of 0-4 with 0.25 increments, 0=excellent; 4=severely reduced.
Measured: Dispense and 1 Week
Overall Lens Fit Acceptance
Graded on a 0-4 point scale (where 0 = should not be worn, 4=perfect), providing a reason if Grade 2 or less
Measured: Dispense and 1 Week

Timeline

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

6 Jul 201727 Sep 2017

First posted21 Jul 2017
Study start6 Jul 2017
Primary completion27 Sep 2017
Study completion27 Sep 2017

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 77 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03226353
Sponsor's protocol ID: EX-MKTG-84
Status last verified: Aug 2019
First submitted: 18 Jul 2017
Last updated: 12 Sep 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

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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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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Performance of Somofilcon A Over One Week in Wearers Adapted to Omafilcon A
ClinicalTrials.gov ID: NCT03226353
Acronym / sponsor ID: EX-MKTG-84
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 77 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 6 Jul 2017 (actual)
Primary completion: 27 Sep 2017 (actual)
Study completion: 27 Sep 2017 (actual)
First posted: 21 Jul 2017 (actual)
Results: Posted 4 Feb 2019

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 determine if habitual or adapted contact lens wearers of Omafilcon A can be confidently refit into Somofilcon A lenses and be successful after one week of daily wear.

The primary outcome variables for this study are:

Investigator responses to refit questions;
Lens fit.

Detailed description

This is a prospective, single-site, dispensing, bilateral wear, open label, daily wear switch study, with the test lens (Somofilcon A) being worn for 7 (+5) days.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
somofilcon A 1-day soft contact lenses	Experimental	Device: somofilcon A, Device: omafilcon AHabitual and refitted wearers of omafilcon A were refit into somofilcon A for a week

Who may qualify

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

Key inclusion criteria (8 listed)

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 soft spherical contact lenses with a power between +6.00 to -10.00D (inclusive) for a minimum 5 days per week, 10 hours per day and anticipates no difficulty wearing contact lenses for 7 days per week, 10 hours per day;
Habitually wears, or is able to be adequately refit into Proclear 1 Day lenses;

Key exclusion criteria (10 listed)

Is participating in any concurrent clinical 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;

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 Acontact lens	Device	somofilcon A 1-day soft contact lenses
omafilcon Acontact lens	Device	somofilcon A 1-day soft contact lenses

Primary outcome

Investigator Opinion On Overall Patient Refit From Omafilcon A to Somofilcon A: Does Somofilcon A Provides Easy and Quick Refit From Omafilcon A?
Time frame: 1 week
Investigator level of agreement using a Likert scale on refitting participants from omafilcon A to somofilcon A at Visit 1 (Strongly Agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree)
Investigator Assessment to Refit- Based on the Investigator Opinion and Lens Fit Outcomes, Would the Investigator Refit the Subject Into Somofilcon A From Omafilcon A?
Time frame: 1 week
Investigator level of agreement on the ease of refitting participants from omafilcon A to somofilcon A using Likert scale (Strongly agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree)
Investigator Assessment to Refit - Does Somofilcon A Performs Better Than Omafilcon A Day?
Time frame: 1 week
Investigator level of agreement on the ease of refitting participants from omafilcon A to somofilcon A using Likert scale (Strongly agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree)
Investigator Assessment to Refit - Does Somofilcon A Provides an Upgrade From Omafilcon A?
Time frame: 1 week
Investigator level of agreement on the ease of refitting participants from omafilcon A to somofilcon A using Likert scale (Strongly agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree)
Lens Fit - Post-blink Lens Movement
Time frame: Dispense and 1 Week
Graded on a scale of 0-4, 1 step, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement.
Lens Fit - Lens Tightness
Time frame: Dispense and 1 week
Graded using 0-100 scale (5% steps) where 0 = extremely loose and 100 = extremely tight.
Lens Fit - Lens Deposition
Time frame: Dispense and 1 week
Graded on a scale of 0-4, with 0.25 increments, 0=no deposits; 4=deposit ≥ 0.5mm or film >75% surface.
Lens Fit - Centration
Time frame: Dispense and 1 Week
(3 point scale: optimum, decentration acceptable, decentration unacceptable)
Lens Fit - Lens Wettability
Time frame: Dispense and 1 Week
Graded on a scale of 0-4 with 0.25 increments, 0=excellent; 4=severely reduced.
Overall Lens Fit Acceptance
Time frame: Dispense and 1 Week
Graded on a 0-4 point scale (where 0 = should not be worn, 4=perfect), providing a reason if Grade 2 or less

Results and safety

Results posted to the registry on 4 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
Overall Participants	77	71

Primary outcome: Investigator Opinion On Overall Patient Refit From Omafilcon A to Somofilcon A: Does Somofilcon A Provides Easy and Quick Refit From Omafilcon A?

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

Measure	Overall Participants n = 69
Strongly disagree	1
Disagree	0
Slightly disagree	13
Slightly Agree	11
Agree	32
Styrongly agree	12

Population analysed: Though 71 participants completed all protocol visits, two are completely excluded from all analyses. One participant was excluded because of three protocol deviations and other Participant was excluded because of an adverse event (non-significant ocular from Omafilcon A).

Primary outcome: Investigator Assessment to Refit- Based on the Investigator Opinion and Lens Fit Outcomes, Would the Investigator Refit the Subject Into Somofilcon A From Omafilcon A?

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

Measure	Overall Participants n = 69
Strongly disagree	0
Disagree	2
Slightly disagree	18
Slightly agree	20
Agree	18
Strongly agree	11

Primary outcome: Investigator Assessment to Refit - Does Somofilcon A Performs Better Than Omafilcon A Day?

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

Measure	Overall Participants n = 69
Strongly disagree	1
Disagree	3
Slightly disagree	30
Sligtly agree	19
Agree	14
Strongly Agree	2

Primary outcome: Investigator Assessment to Refit - Does Somofilcon A Provides an Upgrade From Omafilcon A?

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

Measure	Overall Participants n = 69
Strongly Disagree	1
Disagree	2
Slightly Disagree	19
Slightly agree	22
Agree	19
Strongly agree	6

Adverse events

Time frame: From dispense to completion of follow up, approximately one week for each lens, two weeks total.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Somofilcon A	0 of 71 (0%)	0 of 71 (0%)	0 of 71
Omafilcon A	0 of 71 (0%)	0 of 71 (0%)	0 of 71

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 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 and omafilcon 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 8 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 12 Sep 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 4 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?

Investigator Opinion On Overall Patient Refit From Omafilcon A to Somofilcon A: Does Somofilcon A Provides Easy and Quick Refit From Omafilcon A? (time frame: 1 week). The study lists 10 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 NCT03226353.

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 12 Sep 2019.