MyopiaNCT02299869
Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs. Competitor) of Color Soft Contact Lenses.
A study testing Green (CVI-test) and Grey (CVI-test) in people with Myopia, run by CooperVision, Inc. at 1 site in Mexico.
Trial summary
Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs. Competitor)of Color Soft Contact Lenses Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Myopia
- What is being tested?
- Green (CVI-test) and Grey (CVI-test)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteMexico
- Study dates
- Oct 2014to Nov 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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Is between 18 and 40 years of age (inclusive).
- Has had a self-reported visual exam in the last two years.
- Is an adapted wearer of spherical soft contact lenses.
- Has a contact lens spherical prescription between - 1.00 and - 10.00 (inclusive).
- Has a spectacle cylinder up to 0.75 diopter (D) in each eye
- Can achieve best corrected spectacle distance visual acuity of 20/30 (0.18 logMAR) or better in each eye.
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- Has clear corneas and no active ocular disease.
- Has read, understood and signed the information consent letter.
- Is willing to wear his/hers spectacles over the study contact lenses.
- Is willing to comply with the wear schedule.
- 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 contact lens wear (5 days per week; > 8 hours/day)
- Has a contact lens prescription outside the range of - 1.00 to -10.00D.
- Has a spectacle cylinder ≥1.00D of cylinder in either eye.
- Does not have a pair of corrective spectacles at the time of the visit.
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- Cannot achieve best corrected spectacle distance visual acuity of 20/30 (0.18 logMAR) or better in each eye.
- Presence of clinically significant (grade > 2.0, scale 0-4) anterior segment abnormalities.
- Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
- Slit lamp findings that would contraindicate contact lens wear such as:
- Pathological dry eye or associated findings
- Pterygium, pinguecula, or corneal scars within the visual axis
- Neovascularization > 0.75 mm in from of the limbus
- Giant papillary conjunctivitis (GCP) worse than grade 1
- Anterior uveitis or iritis (past or present)
- Seborrheic eczema, Seborrheic conjunctivitis
- History of corneal ulcers or fungal infections
- Poor personal hygiene
- Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
- Has aphakia, keratoconus or a highly irregular cornea.
- Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
- Has undergone corneal refractive surgery.
- Is participating in any other type of eye related clinical or research study.
Trial locations and contacts
1 site in 1 country.
About this study
Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs. Competitor)of Color Soft Contact Lenses
Read the detailed description
Each lens pair comparison will require two visits over two days, as follows: Visits: V1 (lens dispensing), V2 (20 minutes post lens settling). Each subject will be randomized to wear the test and control lenses in a series of four short fitting comparisons.
- Conditions
- Myopia
- Being tested
- Verde (Competitor-control), Green (CVI-test), Cinza (Competitor-control), Grey (CVI-test), Esmeralda (Competitor-control)
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verde (Competitor-control)Device
Also called methafilcon A
contact lens
Green (CVI-test)Device
Also called methafilcon A
contact lens
Cinza (Competitor-control)Device
Also called methafilcon A
contact lens
Grey (CVI-test)Device
Also called methafilcon A
contact lens
Esmeralda (Competitor-control)Device
Also called methafilcon A
contact lens
Jade (CVI-test)Device
Also called methafilcon A
contact lens
Azul (Competitor-control)Device
Also called methafilcon A
contact lens
Blue (CVI-test)Device
Also called methafilcon A
contact lens
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Verde (Competitor-control) vs. Green (CVI-test) | Other | Each subject was randomized to wear the test and control lenses contralaterally. Receives: Device: Verde (Competitor-control); Device: Green (CVI-test) |
| Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test) | Other | Each subject was randomized to wear the test and control lenses contralaterally. Receives: Device: Cinza (Competitor-control); Device: Grey (CVI-test) |
| Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test) | Other | Each subject was randomized to wear the test and control lenses contralaterally. Receives: Device: Esmeralda (Competitor-control); Device: Jade (CVI-test) |
| Group 4 - Azul (Competitor-control) vs. Blue (CVI-test) | Other | Each subject was randomized to wear the test and control lenses contralaterally. Receives: Device: Azul (Competitor-control); Device: Blue (CVI-test) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cosmetic Appearance Preference
Participant's subjective preference for cosmetic appearance. 3 point Likert Scale. 1=prefer CVI-test lens 2=prefer Competitor-control lens, 3=no preference
Measured: 20 minutes
Comfort
Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent).
Measured: Baseline
Comfort
Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent).
Measured: 20 minutes
Comfort Preference
Participant's subjective preference for comfort on a 3 point Likert Scale. 1=prefer CVI-test lens, 2=prefer Competitor-control lens, 3=no preference
Measured: Baseline
Comfort Preference
Participant's subjective preference for comfort on a 3 point Likert Scale. 1=prefer CVI-test lens, 2=prefer Competitor-control lens, 3=no preference
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2014
- Study completionNov 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruben Velazquez Guerrero, MSc FIACLE, Principal investigator, School of Optometry, National Autonomous University (UNAM), Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299869
- Sponsor's protocol ID
- EX-MKTG-51
- Status last verified
- Jan 2017
- First submitted
- 20 Nov 2014
- Last updated
- 10 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs. Competitor) of Color Soft Contact Lenses.
- ClinicalTrials.gov ID
- NCT02299869
- Acronym / sponsor ID
- EX-MKTG-51
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Posted 24 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs. Competitor)of Color Soft Contact Lenses
Detailed description
Each lens pair comparison will require two visits over two days, as follows: Visits: V1 (lens dispensing), V2 (20 minutes post lens settling). Each subject will be randomized to wear the test and control lenses in a series of four short fitting comparisons.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Verde (Competitor-control) vs. Green (CVI-test) | Other | Device: Verde (Competitor-control), Device: Green (CVI-test)Each subject was randomized to wear the test and control lenses contralaterally. |
| Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test) | Other | Device: Cinza (Competitor-control), Device: Grey (CVI-test)Each subject was randomized to wear the test and control lenses contralaterally. |
| Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test) | Other | Device: Esmeralda (Competitor-control), Device: Jade (CVI-test)Each subject was randomized to wear the test and control lenses contralaterally. |
| Group 4 - Azul (Competitor-control) vs. Blue (CVI-test) | Other | Device: Azul (Competitor-control), Device: Blue (CVI-test)Each subject was randomized to wear the test and control lenses contralaterally. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Is between 18 and 40 years of age (inclusive).
- Has had a self-reported visual exam in the last two years.
- Is an adapted wearer of spherical soft contact lenses.
- Has a contact lens spherical prescription between - 1.00 and - 10.00 (inclusive).
- Has a spectacle cylinder up to 0.75 diopter (D) in each eye
Key exclusion criteria (23 listed)
- Has never worn contact lenses before.
- Currently wears rigid gas permeable contact lenses.
- Has a history of not achieving comfortable contact lens wear (5 days per week; > 8 hours/day)
- Has a contact lens prescription outside the range of - 1.00 to -10.00D.
- Has a spectacle cylinder ≥1.00D 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 |
|---|---|---|
| Verde (Competitor-control)Also: methafilcon Acontact lens | Device | Group 1 - Verde (Competitor-control) vs. Green (CVI-test) |
| Green (CVI-test)Also: methafilcon Acontact lens | Device | Group 1 - Verde (Competitor-control) vs. Green (CVI-test) |
| Cinza (Competitor-control)Also: methafilcon Acontact lens | Device | Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test) |
| Grey (CVI-test)Also: methafilcon Acontact lens | Device | Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test) |
| Esmeralda (Competitor-control)Also: methafilcon Acontact lens | Device | Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test) |
| Jade (CVI-test)Also: methafilcon Acontact lens | Device | Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test) |
| Azul (Competitor-control)Also: methafilcon Acontact lens | Device | Group 4 - Azul (Competitor-control) vs. Blue (CVI-test) |
| Blue (CVI-test)Also: methafilcon Acontact lens | Device | Group 4 - Azul (Competitor-control) vs. Blue (CVI-test) |
Primary outcome
Cosmetic Appearance Preference
Time frame: 20 minutes
Participant's subjective preference for cosmetic appearance. 3 point Likert Scale. 1=prefer CVI-test lens 2=prefer Competitor-control lens, 3=no preference
Comfort
Time frame: Baseline
Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent).
Comfort
Time frame: 20 minutes
Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent).
Comfort Preference
Time frame: Baseline
Participant's subjective preference for comfort on a 3 point Likert Scale. 1=prefer CVI-test lens, 2=prefer Competitor-control lens, 3=no preference
Comfort Preference
Time frame: 20 minutes
Participant's subjective preference for comfort on a 3 point Likert Scale. 1=prefer CVI-test lens, 2=prefer Competitor-control lens, 3=no preference
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 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.
Ruben Velazquez Guerrero, MSc FIACLE principal investigator
School of Optometry, National Autonomous University (UNAM), Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Green (CVI-test) and Grey (CVI-test) in people with Myopia, run by CooperVision, Inc. at 1 site in Mexico.
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 11 inclusion and 23 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 10 Mar 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 Mexico. 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 24 Aug 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?
Cosmetic Appearance Preference (time frame: 20 minutes). The study lists 5 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 10 Mar 2017.