MyopiaNCT02537730

BIOCLEAN MPS (Multi-Purpose Solution) VII in Combination With Biofinity Lens: A Two Week Crossover Study

A study testing Bioclean MPS VII, Aosept Clearcare and comfilcon A in people with Myopia, run by CooperVision, Inc. at 3 sites in Japan.

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

Two week, Open Label, randomized, bilateral, crossover, 1 week of daily wear in each combination (lens / disinfecting cleaning system). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myopia
What is being tested?: Bioclean MPS VII, Aosept Clearcare and comfilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 3 sitesJapan
Study dates: Sep 2015to Jun 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Is over 18 years of age (inclusive)
Has had a self-reported visual exam in the last two years
Has a CL (contact lens) spherical prescription between -0.25D (Diopters) and -12.00D (inclusive)
Has less than 1.00 D spectacle cylinder in each eye
Is correctable to a visual acuity of 20/20 or better in both eyes
Has clear corneas and no active ocular disease

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Has read, understood and signed the informed consent letter
Is willing to comply with the wear schedule (at least 40hrs per week)
Is willing to comply with the visit schedule

Who cannot join

Has never worn contact lenses before
Currently wears rigid gas permeable contact lens
Has a history of not achieving comfortable CL (contact lens) wear (5 days per week; > 8 hours per day)
Has a CL prescription outside the range of -0.25D to -12.00D
Has a spectacle cylinder greater than -0.75D of cylinder in either eye
Has best corrected spectacle distant vision worse than 20/20 in ether eye

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Has any systemic disease affecting ocular health
Is using any systemic or topical medications that will affect ocular health
Has any ocular pathology or sever insufficiency of lacrimal secretion
Has persistent, clinically significant corneal or conjunctival staining
Has active neovascularization or any central corneal scars
Is aphakic
Is pregnant or lactating

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

Kodama Eye Clinic
Joyo-shi, Kyoto, 610-0121
Higashihara Eye Clinic
Kameoka, Kyoto, 621-0861
Iwasaki Eye Clinic
Osaka, Osaka, 542-0082

Other trials in Japan

About this study

Two week, Open Label, randomized, bilateral, crossover, 1 week of daily wear in each combination (lens / disinfecting cleaning system).

Read the detailed description

To determine if patients are unreactive to the lens care solution / Biofinity combination. It is expected that there will be a total of three visits: V1 (Initial), V2 (1 week), \& V3 (2 weeks).

Conditions: Myopia
Being tested: Bioclean MPS VII, Aosept Clearcare, comfilcon A
Medical subject headings: Myopia

What participants receive

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

Bioclean MPS VIIDevice
PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system
Aosept ClearcareDevice
Hydrogen Peroxide Disinfecting and Cleaning system
comfilcon ADevice
Also called Biofinity
contact lens

Study groups in NCT02537730
Study group	Role	What they receive
Bioclean MPS VII / comfilcon A combination	Active comparator	Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study. Receives: Device: Bioclean MPS VII; Device: comfilcon A
Aosept Clearcare / comfilcon A combination	Active comparator	Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study. Receives: Device: Aosept Clearcare; Device: comfilcon A

What is being measured

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

Ocular Health - Corneal Staining
Corneal staining for Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination assessed by slit lamp. Grade 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe.
Measured: 1 week

Secondary outcomes (3)

Comfort
Subjective ratings of comfort scores for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination were assessed at 1 week: after insertion, after 4 hours of wear, after 8 hours of wear, before removal, and after all day wear. Scale 0-10, 0=very bad/poor, 10=very good/excellent.
Measured: 1 week
Dryness
Subjective ratings of dryness for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination were assessed at 1 week: after insertion, after 4 hours of wear, after 8 hours of wear, before removal, and after all day wear. Scale 0-10, 0=very bad/poor, 10=very good/excellent.
Measured: 1 week
Stinging and Burning Sensation
Subjective ratings of stinging and burning sensation for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination. Scale 0-10, 0=difficult to wear, 10=no sensation at all.
Measured: Baseline

Timeline

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

Sep 2015Jun 2016

First posted2 Sep 2015 (estimated)
Study startSep 2015
Primary completionOct 2015
Study completionJun 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: Crossover
Masking: None (open label)
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02537730
Sponsor's protocol ID: CVJ-EX-MKTG-1318
Status last verified: Aug 2020
First submitted: 26 Aug 2015
Last updated: 18 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

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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A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: BIOCLEAN MPS (Multi-Purpose Solution) VII in Combination With Biofinity Lens: A Two Week Crossover Study
ClinicalTrials.gov ID: NCT02537730
Acronym / sponsor ID: CVJ-EX-MKTG-1318
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: Sep 2015
Primary completion: Oct 2015 (actual)
Study completion: Jun 2016 (actual)
First posted: 2 Sep 2015 (estimated)
Results: Posted 20 Sep 2016

Clinical summary

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

Two week, Open Label, randomized, bilateral, crossover, 1 week of daily wear in each combination (lens / disinfecting cleaning system).

Detailed description

To determine if patients are unreactive to the lens care solution / Biofinity combination. It is expected that there will be a total of three visits: V1 (Initial), V2 (1 week), \& V3 (2 weeks).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Bioclean MPS VII / comfilcon A combination	Active comparator	Device: Bioclean MPS VII, Device: comfilcon AParticipants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.
Aosept Clearcare / comfilcon A combination	Active comparator	Device: Aosept Clearcare, Device: comfilcon AParticipants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Is over 18 years of age (inclusive)
Has had a self-reported visual exam in the last two years
Has a CL (contact lens) spherical prescription between -0.25D (Diopters) and -12.00D (inclusive)
Has less than 1.00 D spectacle cylinder in each eye
Is correctable to a visual acuity of 20/20 or better in both eyes

Key exclusion criteria (13 listed)

Has never worn contact lenses before
Currently wears rigid gas permeable contact lens
Has a history of not achieving comfortable CL (contact lens) wear (5 days per week; > 8 hours per day)
Has a CL prescription outside the range of -0.25D to -12.00D
Has a spectacle cylinder greater than -0.75D of cylinder in either eye

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
Bioclean MPS VIIPHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system	Device	Bioclean MPS VII / comfilcon A combination
Aosept ClearcareHydrogen Peroxide Disinfecting and Cleaning system	Device	Aosept Clearcare / comfilcon A combination
comfilcon AAlso: Biofinitycontact lens	Device	Aosept Clearcare / comfilcon A combination, Bioclean MPS VII / comfilcon A combination

Primary outcome

Ocular Health - Corneal Staining
Time frame: 1 week
Corneal staining for Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination assessed by slit lamp. Grade 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe.

3 secondary outcomes

Comfort
Time frame: 1 week
Dryness
Time frame: 1 week
Stinging and Burning Sensation
Time frame: Baseline

Results and safety

Results posted to the registry on 20 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bioclean MPS VII Combo, Then Aosept Clearcare Combo	17	17
Aosept Clearcare Combo, Then Bioclean MPS VII Combo	16	16

Primary outcome: Ocular Health - Corneal Staining

Time frame: 1 week. Number. Unit: Eyes

Measure	Bioclean MPS VII / Comfilcon A Combination n = 33	Aosept Clearcare / Comfilcon A Combination n = 33
Normal	45	53
Trace	21	13
Mild	0	0
Moderate	0	0
Severe	0	0

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From dispense up to two weeks for each study lenses. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bioclean MPS VII / Comfilcon A Combination	0 of 33 (0%)	0 of 33 (0%)	Not reported
Aosept Clearcare / Comfilcon A Combination	0 of 33 (0%)	0 of 33 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
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.

Yuji Kodama, MD, PhD principal investigator

Kodama Eye Clinic

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

Questions about this trial

What is this clinical trial studying?

A study testing Bioclean MPS VII, Aosept Clearcare and comfilcon A in people with Myopia, run by CooperVision, Inc. at 3 sites in Japan.

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 13 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 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Japan. 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 20 Sep 2016). 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 Health - Corneal Staining (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 NCT02537730.

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 18 Aug 2020; AzTrials last refreshed its copy on 26 Oct 2026.