MyopiaNCT02196766
BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens
A study testing Bioclean First Care EX / comfilcon A and Aosept Clearcare / comfilcon A in people with Myopia, run by CooperVision, Inc. at 3 sites in Japan.
Trial summary
To determine if patients are unreactive to the lens care solution / Biofinity combination. 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 First Care EX / comfilcon A and Aosept Clearcare / comfilcon A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesJapan
- Study dates
- Jul 2014to Aug 2014
- 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
- Is currently an adapted spherical soft CL wearer
- Has a CL spherical prescription between - 0.25 and - 12.00 (inclusive)
- Has less than 1.00D spectacle cylinder in each eye.
- Is correctable to a visual acuity of 20/20 or better in both eyes
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- Has clear corneas and no active ocular disease
- Has read, understood and signed the information consent letter.
- Is willing to comply with the wear schedule (at least 40 hrs 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 lenses.
- Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
- Has a CL prescription outside the range of - 0.25 to -12.00D
- Has a spectacle cylinder greater than -0.75D of cylinder in either eye.
- Has best corrected spectacle distance vision worse than 20/20 in either 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 severe 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.
- Has undergone corneal refractive surgery.
- Is participating in any other type of eye related clinical or research study.
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Kokama Eye Clinic
Joyo-shi, Kyoto, 610-0121
Higashihara Clinic
Kameoka, Kyoto, 621-0861
Dougenzaka Ioti Eye Clinic
Shibuya-ku, Tokyo-to, 150-0043
About this study
Official title: BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens: A Two Week Crossover Study
To determine if patients are unreactive to the lens care solution / Biofinity combination.
Read the detailed description
To determine if patients are unreactive to the lens care solution / Biofinity combination in this cross-over study.
- Conditions
- Myopia
- Being tested
- Bioclean First Care EX / comfilcon A, 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 First Care EX / comfilcon AOther
Subjects dispensed Bioclean First Care EX / comfilcon A combination then crossed over to the alternate combination.
Aosept Clearcare / comfilcon AOther
Subjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the alternate combination.
| Study group | Role | What they receive |
|---|---|---|
| Bioclean First Care EX combo, then Aosept Clearcare combo | Active comparator | Subjects dispensed Bioclean First Care EX / comfilcon A combination then crossed over to the Aosept Clearcare / comfilcon A combination. Receives: Other: Bioclean First Care EX / comfilcon A; Other: Aosept Clearcare / comfilcon A |
| Aosept Clearcare combo, then Bioclean First Care EX combo | Active comparator | Subjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the Bioclean First Care EX / comfilcon A combination. Receives: Other: Bioclean First Care EX / comfilcon A; Other: Aosept Clearcare / 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 each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Measured: 1 week
Ocular Health - Conjunctival Redness
Conjunctival redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Measured: 1 week
Ocular Health - Limbal Redness
Limbal redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Measured: 1 week
Ocular Health - Papillary Conjunctivitis
Papillary conjunctivitis for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Measured: 1 week
Secondary outcomes (2)
Stinging Sensation Right After Insertion (Subjective Rating)
Subjective rating of stinging sensation for the combinations is assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).
Measured: Baseline
Burning Sensation Right After Insertion (Subjective Rating)
Subjective rating of burning sensation right after insertion for each combination assessed at baseline. (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.
- First posted22 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionAug 2014
- Study completionAug 2014
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Taku Muraoka, OD, Study director, Director Professional Services, CVI Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196766
- Sponsor's protocol ID
- CVJ-EX-MKTG-1818
- Status last verified
- Jul 2020
- First submitted
- 18 Jul 2014
- Last updated
- 29 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens: A Two Week Crossover Study
- ClinicalTrials.gov ID
- NCT02196766
- Acronym / sponsor ID
- CVJ-EX-MKTG-1818
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 22 Jul 2014 (estimated)
- Results
- Posted 29 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if patients are unreactive to the lens care solution / Biofinity combination.
Detailed description
To determine if patients are unreactive to the lens care solution / Biofinity combination in this cross-over study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioclean First Care EX combo, then Aosept Clearcare combo | Active comparator | Other: Bioclean First Care EX / comfilcon A, Other: Aosept Clearcare / comfilcon ASubjects dispensed Bioclean First Care EX / comfilcon A combination then crossed over to the Aosept Clearcare / comfilcon A combination. |
| Aosept Clearcare combo, then Bioclean First Care EX combo | Active comparator | Other: Bioclean First Care EX / comfilcon A, Other: Aosept Clearcare / comfilcon ASubjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the Bioclean First Care EX / comfilcon A combination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Is over 18 years of age (inclusive)
- Has had a self-reported visual exam in the last two years
- Is currently an adapted spherical soft CL wearer
- Has a CL spherical prescription between - 0.25 and - 12.00 (inclusive)
- Has less than 1.00D spectacle cylinder in each eye.
Key exclusion criteria (15 listed)
- Has never worn contact lenses before.
- Currently wears rigid gas permeable contact lenses.
- Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
- Has a CL prescription outside the range of - 0.25 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 First Care EX / comfilcon ASubjects dispensed Bioclean First Care EX / comfilcon A combination then crossed over to the alternate combination. | Other | Aosept Clearcare combo, then Bioclean First Care EX combo, Bioclean First Care EX combo, then Aosept Clearcare combo |
| Aosept Clearcare / comfilcon ASubjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the alternate combination. | Other | Aosept Clearcare combo, then Bioclean First Care EX combo, Bioclean First Care EX combo, then Aosept Clearcare combo |
Primary outcome
Ocular Health - Corneal Staining
Time frame: 1 week
Corneal staining for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Ocular Health - Conjunctival Redness
Time frame: 1 week
Conjunctival redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Ocular Health - Limbal Redness
Time frame: 1 week
Limbal redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Ocular Health - Papillary Conjunctivitis
Time frame: 1 week
Papillary conjunctivitis for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
2 secondary outcomes
Stinging Sensation Right After Insertion (Subjective Rating)
Time frame: Baseline
Burning Sensation Right After Insertion (Subjective Rating)
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 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.
Taku Muraoka, OD study director
Director Professional Services, CVI Japan
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 First Care EX / comfilcon A and Aosept Clearcare / 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 10 inclusion and 15 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 29 Jul 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 29 Apr 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2020.