MyopiaNCT03134599
Comparison of Clinical Performance and Subjective Preference of Three Contact Lenses
A study testing etafilcon A, methafilcon A - Interozzo and methafilcon A - CVI (CooperVision) in people with Myopia, run by CooperVision, Inc. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the clinical performance and subject's preference out of three LRE (Limbal Ring Enhancing) lens types: etafilcon A (Johnson\&Johnson), methafilcon A (Interozzo), and methafilcon A (CooperVision). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- etafilcon A, methafilcon A - Interozzo and methafilcon A - CVI (CooperVision)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 May 2017to 24 Jun 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18 years and above and has full legal capacity as a volunteer Understand the rights as a research subject and willing and able sign a statement of informed consent
- Existing soft contact lens wearers or previous experience of contact lens wear
- Being able to wear the study lenses for at least eight hours a day
- At least 6/9 visual acuity in each eye with the study lenses
- Astigmatism less than 1.50 D (Diopter) in both eyes
- Agreed to follow the protocol and not to participate in other clinical research for the duration of this study
Who cannot join
- Have an ocular disorder which would normally contraindicate contact lens wear
- Have a systemic disorder or any infectious diseases which would normally contraindicate contact lens wear
- Have previously had any ocular surgery such as corneal refractive surgery
- Have less than 6/9 visual acuity in each eye with the study lenses
- Are currently using any topical medication such as eye drops or ointment
- Have any corneal distortion resulting from previous rigid lens wear or have keratoconus
- Are currently pregnant or lactating
- No previous contact lens wear
Trial locations and contacts
1 site in 1 country.
South Korea1 site
School of Optometry & Vision Science, Catholic University of Daegu, Korea (Rep)
Daegu
About this study
Official title: Comparison of Clinical Performance and Subjective Preference Out of Three Cosmetic Contact Lenses (Limbal Ring-enhancing Lenses, LRE Lenses)
The purpose of this study is to evaluate the clinical performance and subject's preference out of three LRE (Limbal Ring Enhancing) lens types: etafilcon A (Johnson\&Johnson), methafilcon A (Interozzo), and methafilcon A (CooperVision).
Read the detailed description
This will be a subject-masked, bilateral, randomized, crossover dispensing study to compare clinical performance and subjective preference out of three lens types. Sixty subjects will be assigned into three groups and each group will wear the test and control lenses as matched pairs for one week in random order. Lenses will be worn on a daily wear, daily disposable schedule.
- Conditions
- Myopia
- Being tested
- etafilcon A, methafilcon A - Interozzo, methafilcon A - CVI (CooperVision)
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etafilcon ADevice
contact lens
methafilcon A - InterozzoDevice
contact lens
methafilcon A - CVI (CooperVision)Device
contact lens
| Study group | Role | What they receive |
|---|---|---|
| etafilcon A | Active comparator | Not described Receives: Device: etafilcon A |
| methafilcon A - Interozzo | Active comparator | Not described Receives: Device: methafilcon A - Interozzo |
| methafilcon A - CVI | Active comparator | Not described Receives: Device: methafilcon A - CVI (CooperVision) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort
Subjective ratings of comfort for each lens pair was assessed. Scale 0-100, 0=causes pain, 100=very comfortable.
Measured: 1 week per intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start23 May 2017
- Primary completion24 Jun 2017
- Study completion24 Jun 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134599
- Sponsor's protocol ID
- CV_BSCHU
- Status last verified
- Dec 2019
- First submitted
- 26 Apr 2017
- Last updated
- 19 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Performance and Subjective Preference Out of Three Cosmetic Contact Lenses (Limbal Ring-enhancing Lenses, LRE Lenses)
- ClinicalTrials.gov ID
- NCT03134599
- Acronym / sponsor ID
- CV_BSCHU
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 May 2017 (actual)
- Primary completion
- 24 Jun 2017 (actual)
- Study completion
- 24 Jun 2017 (actual)
- First posted
- 1 May 2017 (actual)
- Results
- Posted 22 Feb 2019
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 evaluate the clinical performance and subject's preference out of three LRE (Limbal Ring Enhancing) lens types: etafilcon A (Johnson\&Johnson), methafilcon A (Interozzo), and methafilcon A (CooperVision).
Detailed description
This will be a subject-masked, bilateral, randomized, crossover dispensing study to compare clinical performance and subjective preference out of three lens types. Sixty subjects will be assigned into three groups and each group will wear the test and control lenses as matched pairs for one week in random order. Lenses will be worn on a daily wear, daily disposable schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| etafilcon A | Active comparator | Device: etafilcon A |
| methafilcon A - Interozzo | Active comparator | Device: methafilcon A - Interozzo |
| methafilcon A - CVI | Active comparator | Device: methafilcon A - CVI (CooperVision) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age of 18 years and above and has full legal capacity as a volunteer Understand the rights as a research subject and willing and able sign a statement of informed consent
- Existing soft contact lens wearers or previous experience of contact lens wear
- Being able to wear the study lenses for at least eight hours a day
- At least 6/9 visual acuity in each eye with the study lenses
- Astigmatism less than 1.50 D (Diopter) in both eyes
Key exclusion criteria (8 listed)
- Have an ocular disorder which would normally contraindicate contact lens wear
- Have a systemic disorder or any infectious diseases which would normally contraindicate contact lens wear
- Have previously had any ocular surgery such as corneal refractive surgery
- Have less than 6/9 visual acuity in each eye with the study lenses
- Are currently using any topical medication such as eye drops or ointment
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 |
|---|---|---|
| etafilcon Acontact lens | Device | etafilcon A |
| methafilcon A - Interozzocontact lens | Device | methafilcon A - Interozzo |
| methafilcon A - CVI (CooperVision)contact lens | Device | methafilcon A - CVI |
Primary outcome
Comfort
Time frame: 1 week per intervention
Subjective ratings of comfort for each lens pair was assessed. Scale 0-100, 0=causes pain, 100=very comfortable.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing etafilcon A, methafilcon A - Interozzo and methafilcon A - CVI (CooperVision) in people with Myopia, run by CooperVision, Inc. at 1 site in South Korea.
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 6 inclusion and 8 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 19 Dec 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 South Korea. 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 22 Feb 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?
Comfort (time frame: 1 week per intervention). 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 19 Dec 2019.