MyopiaNCT02920983

A Clinical Comparison of Three Soft Daily Disposable Contact Lenses

A study testing somofilcon A, nelfilcon A II 2 and omafilcon A ll 2 in people with Myopia, run by CooperVision, Inc. at 1 site in United Kingdom.

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

This study aims to compare the clinical performance of the somfilcon A, nelfilcon A II 2 and omafilcon A II 2 daily disposable contact lenses. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Myopia
What is being tested?: somofilcon A, nelfilcon A II 2 and omafilcon A ll 2
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteUnited Kingdom
Study dates: Sep 2016to Feb 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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects will only be eligible for the study if:
They are of legal age (18) and capacity to volunteer.
They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
They are willing and able to follow the protocol.
They agree not to participate in other clinical research for the duration of this study.
They have a contact lens spherical prescription between -1.00 to - 6.00D (Diopters) (inclusive)

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They have a spectacle cylindrical correction of -0.75D or less in each eye.
At dispensing, they can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
They currently use soft contact lenses or have done so in the previous six months.
They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).

Who cannot join

Subjects will not be eligible to take part in the study if:
They have an ocular disorder which would normally contra-indicate contact lens wear.
They have a systemic disorder which would normally contra-indicate contact lens wear.
They are using any topical medication such as eye drops or ointment.
They have had cataract surgery.
They have had corneal refractive surgery.

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They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
They are pregnant or breast-feeding.
They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Eurolens Research - The University of Manchester
Manchester, M13 9PL

Other trials in United Kingdom

About this study

This study aims to compare the clinical performance of the somfilcon A, nelfilcon A II 2 and omafilcon A II 2 daily disposable contact lenses.

Read the detailed description

This will be a randomised, subject-masked, crossover, bilateral study, controlled by cross comparison. Fifty subjects will use each lens type for a week in random sequence. Follow-up visits for each lens will be performed after one week of wear. Lenses will be worn on a daily wear, daily disposable wear schedule.

Conditions: Myopia
Being tested: somofilcon A, nelfilcon A II 2, omafilcon A ll 2
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
nelfilcon A II 2Device
contact lens
omafilcon A ll 2Device
contact lens

Study groups in NCT02920983
Study group	Role	What they receive
somofilcon A	Active comparator	Subjects are randomized to wear somofilcon A for one week during the cross over study. Receives: Device: somofilcon A
nelfilcon A II 2	Active comparator	Subjects are randomized to wear nelfilcon A II 2 for one week during the cross over study. Receives: Device: nelfilcon A II 2
omafilcon A ll 2	Active comparator	Subjects are randomized to wear omafilcon A ll 2 for one week during the cross over study. Receives: Device: omafilcon A ll 2

What is being measured

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

Ocular Physiology
Ocular physiology assessment of by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Measured: 1 week

Secondary outcomes (7)

Lens Fit - Horizontal Centration
Horizontal centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal.
Measured: 1 week
Lens Fit - Vertical Centration
Vertical centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.
Measured: 1 week
Lens Fit - Corneal Coverage
Corneal coverage will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.
Measured: 1 week
Lens Fit - Movement
Lens movement assessed using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.
Measured: 1 week
Lens Surface - Deposition
Lens surface will be assessed using Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Measured: 1 week
Lens Surface - Wettability
Lens wettability will be assessed using Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Measured: 1 week
Visual Acuity
Visual acuity will be assessed by LogMAR.
Measured: 1 week

Timeline

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

Sep 2016Feb 2017

First posted30 Sep 2016 (estimated)
Study startSep 2016
Primary completionNov 2016
Study completionFeb 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: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02920983
Sponsor's protocol ID: EX-MTKG-74 (C16-596)
Status last verified: Oct 2019
First submitted: 29 Sep 2016
Last updated: 17 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Comparison of Three Soft Daily Disposable Contact Lenses
ClinicalTrials.gov ID: NCT02920983
Acronym / sponsor ID: EX-MTKG-74 (C16-596)
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: Sep 2016
Primary completion: Nov 2016 (actual)
Study completion: Feb 2017 (actual)
First posted: 30 Sep 2016 (estimated)
Results: Posted 26 Jun 2019

Clinical summary

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

This study aims to compare the clinical performance of the somfilcon A, nelfilcon A II 2 and omafilcon A II 2 daily disposable contact lenses.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
somofilcon A	Active comparator	Device: somofilcon ASubjects are randomized to wear somofilcon A for one week during the cross over study.
nelfilcon A II 2	Active comparator	Device: nelfilcon A II 2Subjects are randomized to wear nelfilcon A II 2 for one week during the cross over study.
omafilcon A ll 2	Active comparator	Device: omafilcon A ll 2Subjects are randomized to wear omafilcon A ll 2 for one week during the cross over study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 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 Acontact lens	Device	somofilcon A
nelfilcon A II 2contact lens	Device	nelfilcon A II 2
omafilcon A ll 2contact lens	Device	omafilcon A ll 2

Primary outcome

Ocular Physiology
Time frame: 1 week
Ocular physiology assessment of by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

7 secondary outcomes

Lens Fit - Horizontal Centration
Time frame: 1 week
Lens Fit - Vertical Centration
Time frame: 1 week
Lens Fit - Corneal Coverage
Time frame: 1 week
Lens Fit - Movement
Time frame: 1 week
Lens Surface - Deposition
Time frame: 1 week
Lens Surface - Wettability
Time frame: 1 week
Visual Acuity
Time frame: 1 week

Results and safety

Results posted to the registry on 26 Jun 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, Nelfilcon A II 2, Omafilcon A II 2	8	8
Somofilcon A, Omafilcon A II 2, Nelfilcon A II 2	10	10
Nelfilcon A II 2, Somofilcon A, Omafilcon A II 2	7	7
Nelfilcon A II 2, Omafilcon A II 2, Somofilcon A	6	6
Omafilcon A II 2, Nelficon A II 2, Somofilcon A	13	12
Omafilcon A II 2, Somofilcon A, Nelfilcon A II 2	7	7

Primary outcome: Ocular Physiology

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

Measure	Somofilcon A n = 49	Nelfilcon A II 2 n = 48	Omafilcon A ll 2 n = 49
Conjunctival Hyperemia	0.76 (0.26)	0.79 (0.31)	0.78 (0.28)
Limbal Hyperaemia	0.63 (0.24)	0.66 (0.30)	0.65 (0.28)
Corneal Vascularization	0.05 (0.11)	0.05 (0.10)	0.06 (0.09)
Microcysts	0.00 (0.00)	0.00 (0.00)	0.00 (0.00)
Oedema	0.00 (0.00)	0.00 (0.00)	0.00 (0.00)
Corneal Staining	0.33 (0.42)	0.42 (0.43)	0.26 (0.36)
Conjunctival Staining	1.37 (0.65)	0.41 (0.43)	0.23 (0.20)
Paipliiary Conjunctivitis	0.95 (0.28)	0.88 (0.35)	0.93 (0.34)

Population analysed: Protocol deviations and discontinuations account for difference in analysis population

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Subjects were randomized to wear each pair of lenses (Somofilcon A, Nelfilcon A II 2, Omafilcon A II 2 at a random sequence) for One- Week in a random sequence, assessed overall for up to 4 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Somofilcon A	0 of 49 (0%)	4 of 49 (8.2%)	0 of 49
Nelfilcon A II 2	0 of 48 (0%)	3 of 48 (6.3%)	0 of 48
Omafilcon A II 2	0 of 49 (0%)	4 of 49 (8.2%)	0 of 49

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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
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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.

Carole Maldonado-Codinal, PhD, FAAO principal investigator

Eurolens Research, University of Manchester

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, nelfilcon A II 2 and omafilcon A ll 2 in people with Myopia, run by CooperVision, Inc. at 1 site in United Kingdom.

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 10 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 17 Oct 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 United Kingdom. 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 26 Jun 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?

Ocular Physiology (time frame: 1 week). 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 NCT02920983.

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 17 Oct 2019.