Refractive ErrorCOPPERNCT01233089
Fitting Children With Contact Lenses
A study testing Lotrafilcon B contact lens, investigational, Lotrafilcon B contact lens, commercial (AIR OPTIX AQUA) and Lotrafilcon B multifocal contact lens, commercial (AIR OPTIX AQUA MULTIFOCAL) in people with Refractive Error, run by CIBA VISION at 1 site in Canada.
Trial summary
The purpose of this three-month study is to compare the quality of life and ease of fit among children wearing investigational single-vision contact lenses, commercially marketed single-vision contact lenses, and commercially marketed multifocal contact lenses. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Refractive Error
- What is being tested?
- Lotrafilcon B contact lens, investigational, Lotrafilcon B contact lens, commercial (AIR OPTIX AQUA) and Lotrafilcon B multifocal contact lens, commercial (AIR OPTIX AQUA MULTIFOCAL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2010to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Is between 8 and 16 years of age.
- Has the permission of a parent/legal guardian.
- Is willing and able to, or has a parent/legal guardian who is willing and able to help them, follow instructions and maintain the appointment schedule.
- Has had an ocular examination in the last two years.
- Has never worn contact lenses before.
- Has clear corneas and no active ocular disease.
Show all 9Show fewer
- Can be successfully fit with the lenses to be used in the study.
- Has 20/25 or better best corrected visual acuity in each eye.
- Other protocol-defined inclusion/exclusion criteria may apply.
Who cannot join
- Has any ocular disease.
- Has a systemic condition that may affect a study outcome variable.
- Is using any systemic or topical medications that may affect ocular health.
- Has ocular or systemic allergies that could interfere with contact lens wear.
- Has any ocular pathology or condition that would affect the wearing of contact lenses.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality of Life and Ease of Fit, Fitting Children With Contact Lenses
The purpose of this three-month study is to compare the quality of life and ease of fit among children wearing investigational single-vision contact lenses, commercially marketed single-vision contact lenses, and commercially marketed multifocal contact lenses.
- Conditions
- Refractive Error
- Being tested
- Lotrafilcon B contact lens, investigational, Lotrafilcon B contact lens, commercial (AIR OPTIX AQUA), Lotrafilcon B multifocal contact lens, commercial (AIR OPTIX AQUA MULTIFOCAL), Contact lens care system (ClearCare)
- Keywords
- Myopia, contact lenses, children
- Medical subject headings
- Refractive Errors, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lotrafilcon B contact lens, investigationalDevice
Investigational silicone hydrogel, spherical contact lens worn on a daily wear basis and replaced monthly
Lotrafilcon B contact lens, commercial (AIR OPTIX AQUA)Device
Also called AIR OPTIX AQUA
Commercially available silicone hydrogel, spherical contact lens worn on a daily wear basis and replaced monthly.
Lotrafilcon B multifocal contact lens, commercial (AIR OPTIX AQUA MULTIFOCAL)Device
Also called AIR OPTIX AQUA MULTIFOCAL
Commercially available silicone hydrogel, multifocal, contact lens worn on a daily wear basis and replaced monthly.
Contact lens care system (ClearCare)Device
Also called CLEAR CARE
Commercially available, hydrogen peroxide-based system for cleaning, disinfecting, and storing contact lenses
| Study group | Role | What they receive |
|---|---|---|
| CARE | Experimental | Investigational single-vision contact lenses worn bilaterally on a daily wear basis and replaced monthly Receives: Device: Lotrafilcon B contact lens, investigational; Device: Contact lens care system (ClearCare) |
| AIR OPTIX AQUA | Active comparator | Commercially available single-vision contact lenses worn bilaterally on a daily wear basis and replaced monthly Receives: Device: Lotrafilcon B contact lens, commercial (AIR OPTIX AQUA); Device: Contact lens care system (ClearCare) |
| AIR OPTIX AQUA MULTIFOCAL | Active comparator | Commercially available multifocal contact lenses worn bilaterally on a daily wear basis and replaced monthly Receives: Device: Lotrafilcon B multifocal contact lens, commercial (AIR OPTIX AQUA MULTIFOCAL); Device: Contact lens care system (ClearCare) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Measured: 3 months
Ease of fit
A participant was deemed to be successfully fit if they could insert/remove, handle and maintain study lenses by the 1-week visit and continued in the study.
Measured: 1 week
PREP score
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Refractive ErrorStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- CIBA VISION
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Waterloo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233089
- Sponsor's protocol ID
- P-368-C-107
- Other IDs
- P/346/10/C
- Acronym
- COPPER
- Status last verified
- Sep 2011
- First submitted
- 1 Nov 2010
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Paquette L, Jones DA, Sears M, Nandakumar K, Woods CA. Contact lens fitting and training in a child and youth population. Cont Lens Anterior Eye. 2015 Dec;38(6):419-23. doi: 10.1016/j.clae.2015.05.002. Epub 2015 Jun 9.
PubMed 26070228
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Ease of Fit, Fitting Children With Contact Lenses
- ClinicalTrials.gov ID
- NCT01233089
- Acronym / sponsor ID
- COPPER / P-368-C-107
- Conditions
- Refractive Error
- Keywords
- Myopia, contact lenses, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- CIBA VISIONIndustry (pharma, biotech, devices)
- Collaborators
- University of Waterloo
- Study start
- Sep 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 3 Nov 2010 (estimated)
- Results
- Not posted in the source record
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 three-month study is to compare the quality of life and ease of fit among children wearing investigational single-vision contact lenses, commercially marketed single-vision contact lenses, and commercially marketed multifocal contact lenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CARE | Experimental | Device: Lotrafilcon B contact lens, investigational, Device: Contact lens care system (ClearCare)Investigational single-vision contact lenses worn bilaterally on a daily wear basis and replaced monthly |
| AIR OPTIX AQUA | Active comparator | Device: Lotrafilcon B contact lens, commercial (AIR OPTIX AQUA), Device: Contact lens care system (ClearCare)Commercially available single-vision contact lenses worn bilaterally on a daily wear basis and replaced monthly |
| AIR OPTIX AQUA MULTIFOCAL | Active comparator | Device: Lotrafilcon B multifocal contact lens, commercial (AIR OPTIX AQUA MULTIFOCAL), Device: Contact lens care system (ClearCare)Commercially available multifocal contact lenses worn bilaterally on a daily wear basis and replaced monthly |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Is between 8 and 16 years of age.
- Has the permission of a parent/legal guardian.
- Is willing and able to, or has a parent/legal guardian who is willing and able to help them, follow instructions and maintain the appointment schedule.
- Has had an ocular examination in the last two years.
- Has never worn contact lenses before.
Key exclusion criteria (6 listed)
- Has any ocular disease.
- Has a systemic condition that may affect a study outcome variable.
- Is using any systemic or topical medications that may affect ocular health.
- Has ocular or systemic allergies that could interfere with contact lens wear.
- Has any ocular pathology or condition that would affect the wearing of contact lenses.
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 |
|---|---|---|
| Lotrafilcon B contact lens, investigationalInvestigational silicone hydrogel, spherical contact lens worn on a daily wear basis and replaced monthly | Device | CARE |
| Lotrafilcon B contact lens, commercial (AIR OPTIX AQUA)Also: AIR OPTIX AQUACommercially available silicone hydrogel, spherical contact lens worn on a daily wear basis and replaced monthly. | Device | AIR OPTIX AQUA |
| Lotrafilcon B multifocal contact lens, commercial (AIR OPTIX AQUA MULTIFOCAL)Also: AIR OPTIX AQUA MULTIFOCALCommercially available silicone hydrogel, multifocal, contact lens worn on a daily wear basis and replaced monthly. | Device | AIR OPTIX AQUA MULTIFOCAL |
| Contact lens care system (ClearCare)Also: CLEAR CARECommercially available, hydrogen peroxide-based system for cleaning, disinfecting, and storing contact lenses | Device | AIR OPTIX AQUA, AIR OPTIX AQUA MULTIFOCAL, CARE |
Primary outcome
Visual acuity
Time frame: 3 months
Ease of fit
Time frame: 1 week
A participant was deemed to be successfully fit if they could insert/remove, handle and maintain study lenses by the 1-week visit and continued in the study.
PREP score
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2016.
- Results publication: PubMed 26070228Paquette L, Jones DA, Sears M, Nandakumar K, Woods CA. Contact lens fitting and training in a child and youth population. Cont Lens Anterior Eye. 2015 Dec;38(6):419-23. doi: 10.1016/j.clae.2015.05.002. Epub 2015 Jun 9.
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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 Lotrafilcon B contact lens, investigational, Lotrafilcon B contact lens, commercial (AIR OPTIX AQUA) and Lotrafilcon B multifocal contact lens, commercial (AIR OPTIX AQUA MULTIFOCAL) in people with Refractive Error, run by CIBA VISION at 1 site in Canada.
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 6 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 21 Nov 2016. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual acuity (time frame: 3 months). The study lists 3 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 NCT01233089, which also lists 1 linked publication.
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 21 Nov 2016.