MyopiaNCT02542072

Multi-Center Clinical Evaluation of Two Reusable Soft Contact Lenses

A study testing comfilcon A and samfilcon A in people with Myopia, run by CooperVision, Inc. at 5 sites in 2 countries.

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 compare the subjective performance of comfilcon A lens against samfilcon A lens after 4 weeks of reusable lens wear. Read more about this study

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Myopia
What is being tested?: comfilcon A and samfilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 5 sitesin 2 countries
Study dates: Aug 2015to Mar 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 18 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Spherical distance Contact Lens prescription between -1.00 and -6.00D or +1.00 to +4.00D in both eyes (inclusive)
Adapted soft Contact Lens wearers (i.e. >1 month), daily disposable and reusable lens wearers.
Spectacle cylinder 0.75D in both eyes.
Correctable to 6/9 (20/30) in both eyes
Be between 18 and 50 years of age (inclusive)
Able to read, comprehend and sign an informed consent
Own a mobile phone and be willing to respond to Short Message Service (SMS) survey
Willing to comply with the wear and study visit schedule

Who cannot join

Existing Biofinity or Ultra wearers
Any active corneal infection, injury or inflammation
Systemic or ocular allergies, which might interfere with Contact Lens wear
Systemic disease, which might interfere with Contact Lens wear
Ocular disease, which might interfere with Contact Lens wear
Strabismus or amblyopia

Show all 12Show fewer

Subjects who have undergone corneal refractive surgery
Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
Pregnant or lactating
Use of systemic/topical medication contraindicating Contact Lens wear
Diabetic
Site employees or family members of site employees

Trial locations and contacts

5 sites in 2 countries.

Country

City, postcode or hospital

5 sites in 2 countries

United Kingdom3 sites

Tempany's Boutique Opticians
Broadstone, Dorset, BH18 8DP
Brock & Houlford
Chew Magna, Bristol, BS40 8PR
David Gould Opticians
Rawtenstall, Lancashire, BB4 7QN

Other trials in United Kingdom

United States2 sites

Complete Eye Care of Medina
Medina, Minnesota, 55340
Golden Optometric Group
Whittier, California, 90606

Other trials in United States

About this study

The purpose of this study is to compare the subjective performance of comfilcon A lens against samfilcon A lens after 4 weeks of reusable lens wear.

Read the detailed description

This will be a 90 subject, randomized, bilateral, subject-masked, dispensing, cross-over study comparing comfilcon A versus samfilcon A lenses over 8 weeks of daily wear (2 x 4-weeks). Both eyes will wear the same lens (test or control) for 4 weeks in a randomized fashion. Subjects will be masked to lens type and investigators will be masked to the lens codes.

Conditions: Myopia
Being tested: comfilcon A, samfilcon A
Medical subject headings: Myopia

What participants receive

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

comfilcon ADevice
contact lens
samfilcon ADevice
contact lens

Study groups in NCT02542072
Study group	Role	What they receive
comfilcon A	Active comparator	Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study. Receives: Device: comfilcon A
samfilcon A	Active comparator	Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study. Receives: Device: samfilcon A

What is being measured

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

Comfort
Subjective ratings of comfort (comfort after insertion, typical comfort just prior to removal, and overall comfort) for comfilcon A and samfilcon A assessed at baseline, 2 weeks, and 4 weeks. Scale of 0-10 (0=painful, 10=can't feel the lenses).
Measured: Baseline, 2 weeks, 4 weeks

Secondary outcomes (17)

Comfortable Wearing Time Via SMS (Short Message Service)
Comfortable wearing times (WTs) via SMS (Short Message Service) for comfilcon A and samfilcon A lenses assessed at days 3, 12, and 26 at hours 8:00 am, 12:00 pm, 4:00 pm, and 8:00 pm. Scale of 0-10 (0=painful, 10=can't feel the lenses).
Measured: Days 3, 12, 26
Wearing Times
Average wear time and comfortable wearing times (WTs) in hours for habitual, comfilcon A, and samfilcon A lenses.
Measured: Baseline, 2 weeks, 4 weeks
Deterioration in Comfort
Deterioration of comfortable wearing time for habitual, comfilcon A, samfilcon A lenses. Subjects answered 'yes' or 'no' to the following question 'does contact lens comfort deteriorate during wear?'. Yes=deterioration in comfort present, No=deterioration in comfort absent
Measured: Baseline, 2 weeks, 4 weeks
Vision Quality
Vision quality of comfilcon A and samfilcon A lenses. Scale 0-10, 0=completely dissatisfied, 10=completely satisfied.
Measured: Baseline, 2 weeks, 4 weeks
Overall Lens Handling
Handling (ease of insertion and ease of removal) for comfilcon A and samfilcon A lenses. Scale 0-10, 0=very difficult to handle, 10=very easy to handle.
Measured: Baseline, 2 weeks, 4 weeks
Biomicroscopy Scores
Biomicroscopy for comfilcon A and samfilcon A lens assessed. Scale 0-4 in 0.5 steps 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Measured: Baseline, 2 weeks, 4 weeks
Lens Surface Wetting
Lens surface wettability assessment for comfilcon A and samfilcon A lenses. Scale 0-4 in 0.5 steps, 0=very poor, 4=excellent
Measured: Baseline, 2 weeks, 4 weeks
Film Deposits
Front surface film deposits for comfilcon A and samfilcon A lenses. Scale 0-4, 0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=Heavy film visible to the naked eye.
Measured: 2 weeks and 4 weeks
White Spot Deposits
Number of white spot deposits for comfilcon A and samfilcon A lenses.
Measured: 2 weeks and 4 weeks
Visual Acuity (VA)
Visual acuity (VA) for comfilcon A and samfilcon A lens wear is assessed using Snellen.
Measured: Baseline, 2 weeks, 4 weeks
Lens Centration
Lens centration will be recorded by degree and direction in the primary position. 0=Centered -optimal, 1=Decentered slightly, 2=Substantially decentered (>0.5mm)
Measured: Baseline, 2 weeks, 4 weeks
Corneal Coverage
Investigator assessment of corneal coverage for comfilcon A and samfilcon A lenes.
Yes = coverage at all times or No = coverage incomplete
Measured: Baseline Visit, 2 weeks follow-up, 4-weeks follow-up
Post-Blink Movement
Post-blink movement for comifilcon A and samfilcon A lenses are assessed. 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement
Measured: Baseline, 2 weeks, 4 weeks
Primary Gaze Lag
Investigator assessment of primary gaze lag for comfilcon A and samfilcon A lenses. Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement
Measured: Baseline, 2 weeks, and 4 weeks
Lens Tightness Push-up
Investigator assessment of lens tightness push-up for comfilcon A and samfilcon A lenses.
Scale 0%-100% continuous scale, 100%=No movement, 50%=Optimum, 0%=Falls from cornea without lid support
Measured: Baseline, 2 weeks, 4 weeks
Overall Fit Acceptance
Overall fit acceptance for comfilcon A and samfilcon A lenses. Scale 0-4, 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimum acceptable, early review, 3=Not perfect but okay to dispense, 4=Perfect
Measured: Baseline, 2 weeks, 4 weeks
Dryness
Subjective response of dryness for comfilcon A and samfilcon A lenses during a typical day of wear and prior to removal. Scale of 0-10, 10=No dryness, 0=Extremely dry
Measured: Baseline, 2 weeks, 4 weeks

Timeline

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

Aug 2015Mar 2016

First posted4 Sep 2015 (estimated)
Study startAug 2015
Primary completionFeb 2016
Study completionMar 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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02542072
Sponsor's protocol ID: EX-MKTG-59 (VISA-406)
Status last verified: Sep 2017
First submitted: 31 Aug 2015
Last updated: 24 Oct 2017
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

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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-Center Clinical Evaluation of Two Reusable Soft Contact Lenses
ClinicalTrials.gov ID: NCT02542072
Acronym / sponsor ID: EX-MKTG-59 (VISA-406)
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: Aug 2015
Primary completion: Feb 2016 (actual)
Study completion: Mar 2016 (actual)
First posted: 4 Sep 2015 (estimated)
Results: Posted 21 Mar 2017

Clinical summary

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

The purpose of this study is to compare the subjective performance of comfilcon A lens against samfilcon A lens after 4 weeks of reusable lens wear.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
comfilcon A	Active comparator	Device: comfilcon AParticipants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
samfilcon A	Active comparator	Device: samfilcon AParticipants were randomized to wear the samfilcon A lens pair for one month during the cross over study.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Spherical distance Contact Lens prescription between -1.00 and -6.00D or +1.00 to +4.00D in both eyes (inclusive)
Adapted soft Contact Lens wearers (i.e. >1 month), daily disposable and reusable lens wearers.
Spectacle cylinder 0.75D in both eyes.
Correctable to 6/9 (20/30) in both eyes
Be between 18 and 50 years of age (inclusive)

Key exclusion criteria (12 listed)

Existing Biofinity or Ultra wearers
Any active corneal infection, injury or inflammation
Systemic or ocular allergies, which might interfere with Contact Lens wear
Systemic disease, which might interfere with Contact Lens wear
Ocular disease, which might interfere with Contact Lens wear

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
comfilcon Acontact lens	Device	comfilcon A
samfilcon Acontact lens	Device	samfilcon A

Primary outcome

Comfort
Time frame: Baseline, 2 weeks, 4 weeks
Subjective ratings of comfort (comfort after insertion, typical comfort just prior to removal, and overall comfort) for comfilcon A and samfilcon A assessed at baseline, 2 weeks, and 4 weeks. Scale of 0-10 (0=painful, 10=can't feel the lenses).

17 secondary outcomes

Comfortable Wearing Time Via SMS (Short Message Service)
Time frame: Days 3, 12, 26
Wearing Times
Time frame: Baseline, 2 weeks, 4 weeks
Deterioration in Comfort
Time frame: Baseline, 2 weeks, 4 weeks
Vision Quality
Time frame: Baseline, 2 weeks, 4 weeks
Overall Lens Handling
Time frame: Baseline, 2 weeks, 4 weeks
Biomicroscopy Scores
Time frame: Baseline, 2 weeks, 4 weeks
Lens Surface Wetting
Time frame: Baseline, 2 weeks, 4 weeks
Film Deposits
Time frame: 2 weeks and 4 weeks
White Spot Deposits
Time frame: 2 weeks and 4 weeks
Visual Acuity (VA)
Time frame: Baseline, 2 weeks, 4 weeks
Lens Centration
Time frame: Baseline, 2 weeks, 4 weeks
Corneal Coverage
Time frame: Baseline Visit, 2 weeks follow-up, 4-weeks follow-up
Post-Blink Movement
Time frame: Baseline, 2 weeks, 4 weeks
Primary Gaze Lag
Time frame: Baseline, 2 weeks, and 4 weeks
Lens Tightness Push-up
Time frame: Baseline, 2 weeks, 4 weeks
Overall Fit Acceptance
Time frame: Baseline, 2 weeks, 4 weeks
Dryness
Time frame: Baseline, 2 weeks, 4 weeks

Results and safety

Results posted to the registry on 21 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Comfilcon A, Then Samfilcon A	44	39
Samfilcon A, Then Comfilcon A	46	43

Primary outcome: Comfort

Time frame: Baseline, 2 weeks, 4 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Habitual Lens (Baseline) n = 90	Comfilcon A (2 Weeks) n = 82	Samfilcon A (2 Weeks) n = 82	Comfilcon A (4 Weeks) n = 82	Samfilcon A (4 Weeks) n = 80
Comfort after insertion	8.85 (1.92)	9.06 (1.40)	8.71 (1.81)	8.84 (1.56)	8.60 (1.80)
Typical comfort just prior to removal	7.72 (2.06)	7.68 (2.11)	7.09 (2.30)	7.38 (2.32)	6.94 (2.22)
Overall comfort	8.80 (1.75)	8.33 (1.81)	7.90 (1.90)	8.01 (1.95)	7.76 (1.76)

Population analysed: Number of participants analyzed is different from participant flow due to protocol deviations.

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected over the course of the study duration (8 week wear period). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Comfilcon A	0 of 90 (0%)	0 of 90 (0%)	Not reported
Samfilcon A	0 of 90 (0%)	0 of 90 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
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
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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.

Graeme Young principal investigator

VisionCare

5 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing comfilcon A and samfilcon A in people with Myopia, run by CooperVision, Inc. at 5 sites in 2 countries.

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 12 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 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United Kingdom, United States. 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 21 Mar 2017). 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: Baseline, 2 weeks, 4 weeks). 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 NCT02542072.

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 24 Oct 2017.