MyopiaNCT02510820

The Clinical Performance of the Biofinity Contact Lens (Comfilcon A) With Two Lens Care Systems

A study testing comfilcon A, Synergi and Biotrue 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

Who is it for?: Any age
Conditions the study is for: Myopia
What is being tested?: comfilcon A, Synergi and Biotrue
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: May 2015to Oct 2015
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

They are of legal age 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 - 0.50 to - 6.00 (inclusive)
They have a spectacle cylindrical correction of -1.00D (Diopters) or less in each eye.

Show all 9Show fewer

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 silicone hydrogel soft contact lenses.
They are willing to comply with the wear schedule (at least 5 days per week, ≥8 hours/day).

Who cannot join

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.
They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.

Show all 10Show fewer

They are pregnant or lactating.
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
Manchester, M13 9PL

Other trials in United Kingdom

About this study

This will be a controlled and randomized, single-masked, crossover study in which 48 subjects will use the Biofinity Contact Lens (comfilcon A) with each of the two lens care products ('solutions'), (Synergi and Biotrue Multi-purpose Solution) for one month each. Follow-up visits for each solution will take place at one week, two weeks and four weeks: with a one-week 'wash-out' period between the solutions. Key outcome measures for this study include biomicroscopic and subjective responses to the lens/solution combinations.

Conditions: Myopia
Being tested: comfilcon A, Synergi, Biotrue, stenfilcon 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
Also called Biofinity
soft contact lens
SynergiDevice
Multipurpose solution
BiotrueDevice
Multipurpose solution
stenfilcon AOther
daily disposable contact lenses for washout period

Study groups in NCT02510820
Study group	Role	What they receive
Synergi / comfilcon A	Active comparator	Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study. Receives: Device: comfilcon A; Device: Synergi; Other: stenfilcon A
Biotrue / comfilcon A	Active comparator	Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study. Receives: Device: comfilcon A; Device: Biotrue; Other: stenfilcon A

What is being measured

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

Conjunctival Hyperaemia
Conjunctival hyperaemia of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.
Measured: Baseline, 1 week, 2 weeks, 4 weeks
Limbal Hyperaemia
Limbal hyperaemia of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.
Measured: Baseline, 1 week, 2 weeks, 4 weeks
Corneal Staining
Corneal staining of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=none, 4=patch.
Measured: Baseline, 1 week, 2 weeks, 4 weeks
Papillary Conjunctivitis
Papillary conjunctivitis of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.
Measured: Baseline, 1 week, 2 weeks, 4 weeks
Comfort
Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 1 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.
Measured: 1 week
Comfort
Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 2 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.
Measured: 2 weeks
Comfort
Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 4 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.
Measured: 4 weeks
Vision
Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.
Measured: 1 week
Vision
Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 2 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.
Measured: 2 weeks
Vision
Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 4 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.
Measured: 4 weeks
Dryness
Subjective assessment of dryness for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week visit. Scale 0-100, 0=extremely dry 100=not dry at all.
Measured: 1 week, 2 weeks, 4 weeks
Burning/Stinging
Subjective assessment of burning/stinging for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week visit. Scale 0-100, 0=Extreme stinging / burning, 100=No stinging / burning sensation.
Measured: 1 week, 2 weeks, 4 weeks
Ocular Redness
Subjective ocular redness of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=extremely poor. intolerable levels of redness, 100=excellent, no redness.
Measured: 1 week, 2 weeks, 4 weeks
Ease of Lens Insertion
Subjective assessment of insertionfor Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=unmanageable. lenses impossible to insert, 100=excellent. no problem with lens insertion.
Measured: 1 week, 2 weeks, 4 weeks
Ease of Lens Removal
Subjective assessment of removal for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=unmanageable. lenses impossible to remove, 100=excellent. no problem with lens remove.
Measured: 1 week, 2 weeks, 4 weeks
Ease of Use of Solution
Subjective ease of use for Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visit. Scale 0-100, 0=very difficult, 100=very easy
Measured: 1 week, 2 weeks, 4 weeks
Overall Score
Subjective overall scores Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visit. Scale 0-100, 0=extremely poor, 100=excellent, highly impressed.
Measured: 1 week, 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.

May 2015Oct 2015

First posted29 Jul 2015 (estimated)
Study startMay 2015
Primary completionSep 2015
Study completionOct 2015

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: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02510820
Sponsor's protocol ID: EX-MKTG-54
Status last verified: Jan 2017
First submitted: 16 Jul 2015
Last updated: 1 Feb 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 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Clinical Performance of the Biofinity Contact Lens (Comfilcon A) With Two Lens Care Systems
ClinicalTrials.gov ID: NCT02510820
Acronym / sponsor ID: EX-MKTG-54
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: May 2015
Primary completion: Sep 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 29 Jul 2015 (estimated)
Results: Posted 1 Feb 2017

Clinical summary

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

Study design

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

Arm	Type	Receives
Synergi / comfilcon A	Active comparator	Device: comfilcon A, Device: Synergi, Other: stenfilcon AParticipants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
Biotrue / comfilcon A	Active comparator	Device: comfilcon A, Device: Biotrue, Other: stenfilcon AParticipants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (9 listed)

They are of legal age 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 - 0.50 to - 6.00 (inclusive)

Key exclusion criteria (10 listed)

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.

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 AAlso: Biofinitysoft contact lens	Device	Biotrue / comfilcon A, Synergi / comfilcon A
SynergiMultipurpose solution	Device	Synergi / comfilcon A
BiotrueMultipurpose solution	Device	Biotrue / comfilcon A
stenfilcon Adaily disposable contact lenses for washout period	Other	Biotrue / comfilcon A, Synergi / comfilcon A

Primary outcome

Conjunctival Hyperaemia
Time frame: Baseline, 1 week, 2 weeks, 4 weeks
Conjunctival hyperaemia of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.
Limbal Hyperaemia
Time frame: Baseline, 1 week, 2 weeks, 4 weeks
Limbal hyperaemia of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.
Corneal Staining
Time frame: Baseline, 1 week, 2 weeks, 4 weeks
Corneal staining of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=none, 4=patch.
Papillary Conjunctivitis
Time frame: Baseline, 1 week, 2 weeks, 4 weeks
Papillary conjunctivitis of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.
Comfort
Time frame: 1 week
Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 1 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.
Comfort
Time frame: 2 weeks
Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 2 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.
Comfort
Time frame: 4 weeks
Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 4 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.
Vision
Time frame: 1 week
Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.
Vision
Time frame: 2 weeks
Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 2 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.
Vision
Time frame: 4 weeks
Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 4 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.
Dryness
Time frame: 1 week, 2 weeks, 4 weeks
Subjective assessment of dryness for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week visit. Scale 0-100, 0=extremely dry 100=not dry at all.
Burning/Stinging
Time frame: 1 week, 2 weeks, 4 weeks
Subjective assessment of burning/stinging for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week visit. Scale 0-100, 0=Extreme stinging / burning, 100=No stinging / burning sensation.
Ocular Redness
Time frame: 1 week, 2 weeks, 4 weeks
Subjective ocular redness of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=extremely poor. intolerable levels of redness, 100=excellent, no redness.
Ease of Lens Insertion
Time frame: 1 week, 2 weeks, 4 weeks
Subjective assessment of insertionfor Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=unmanageable. lenses impossible to insert, 100=excellent. no problem with lens insertion.
Ease of Lens Removal
Time frame: 1 week, 2 weeks, 4 weeks
Subjective assessment of removal for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=unmanageable. lenses impossible to remove, 100=excellent. no problem with lens remove.
Ease of Use of Solution
Time frame: 1 week, 2 weeks, 4 weeks
Subjective ease of use for Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visit. Scale 0-100, 0=very difficult, 100=very easy
Overall Score
Time frame: 1 week, 2 weeks, 4 weeks
Subjective overall scores Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visit. Scale 0-100, 0=extremely poor, 100=excellent, highly impressed.

Results and safety

Results posted to the registry on 1 Feb 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
Synergi/Comfilcon A Combo, Then Biotrue/Comfilcon A Combo	21	21
Biotrue/Comfilcon A Combo, Then Synergi/Comfilcon A Combo	27	26

Primary outcome: Conjunctival Hyperaemia

Time frame: Baseline, 1 week, 2 weeks, 4 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Synergi / Comfilcon A n = 47	Biotrue / Comfilcon A n = 48
Baseline	0.84 (0.24)	0.87 (0.21)
1 week	0.87 (0.21)	0.87 (0.22)
2 weeks	0.88 (0.24)	0.83 (0.21)
4 weeks	0.90 (0.21)	0.82 (0.17)

Population analysed: The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.

Primary outcome: Limbal Hyperaemia

Time frame: Baseline, 1 week, 2 weeks, 4 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Synergi / Comfilcon A n = 47	Biotrue / Comfilcon A n = 48
Baseline	0.73 (0.26)	0.77 (0.22)
1 week	0.80 (0.23)	0.75 (0.24)
2 weeks	0.73 (0.25)	0.70 (0.26)
4 weeks	0.78 (0.22)	0.72 (0.21)

Population analysed: The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.

Primary outcome: Corneal Staining

Time frame: Baseline, 1 week, 2 weeks, 4 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Synergi / Comfilcon A n = 47	Biotrue / Comfilcon A n = 48
Baseline	0.30 (0.48)	0.17 (0.34)
1 week	0.34 (0.40)	0.67 (0.47)
2 weeks	0.38 (0.46)	0.59 (0.54)
4 weeks	0.31 (0.42)	0.62 (0.51)

Population analysed: The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.

Primary outcome: Papillary Conjunctivitis

Time frame: Baseline, 1 week, 2 weeks, 4 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Synergi / Comfilcon A n = 47	Biotrue / Comfilcon A n = 48
Baseline	1.04 (0.22)	1.07 (0.24)
1 week	1.05 (0.24)	1.04 (0.23)
2 weeks	1.05 (0.26)	1.06 (0.20)
4 weeks	1.09 (0.24)	1.06 (0.24)

Population analysed: The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Synergi/Comfilcon A Combo, Then Biotrue/Comfilcon A Combo	0 of 21 (0%)	0 of 21 (0%)	Not reported
Biotrue/Comfilcon A Combo, Then Synergi/Comfilcon A Combo	0 of 27 (0%)	0 of 27 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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-Codina principal investigator

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 comfilcon A, Synergi and Biotrue 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 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 1 Feb 2017. 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 1 Feb 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?

Conjunctival Hyperaemia (time frame: Baseline, 1 week, 2 weeks, 4 weeks). The study lists 17 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 NCT02510820.

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 1 Feb 2017.