MyopiaNCT01338402
Evaluation of the Performance of AIR OPTIX® COLORS
A study testing Lotrafilcon B contact lens, Lotrafilcon B contact lens with color and Phemfilcon A contact lens with color in people with Myopia, run by CIBA VISION at 1 site in Canada.
Trial summary
The purpose of this study was to assess the ocular response to and performance of the cosmetically printed silicone hydrogel contact lens AIR OPTIX® COLORS compared to FRESHLOOK® COLORBLENDS. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- Lotrafilcon B contact lens, Lotrafilcon B contact lens with color and Phemfilcon A contact lens with color
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2011to Mar 2012
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Full legal capacity to volunteer;
- Read and sign information and consent letter;
- Willing and able to follow instructions and maintain the appointment schedule;
- Ocular examination in the last two years;
- Currently wears soft contact lenses on a daily wear basis;
- Contact lens prescription between -1.50 diopters and -5.00 diopters;
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Any ocular disease;
- Any systemic condition that may affect a study outcome variable;
- Any systemic or topical medications that may affect ocular health;
- Known sensitivity to the diagnostic pharmaceuticals used in the study;
- Unable to achieve an acceptable fit with the study lenses;
- Anisometropia >1.00 diopter or astigmatism >0.75 diopter;
- Use of lubricating/rewetting eye drops.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Contact Lens Research, University of Waterloo
Waterloo, Ontario, N2L 3G1
About this study
The purpose of this study was to assess the ocular response to and performance of the cosmetically printed silicone hydrogel contact lens AIR OPTIX® COLORS compared to FRESHLOOK® COLORBLENDS.
Read the detailed description
The study was conducted in two phases. Phase 1 was an adaptation phase where participants wore AIR OPTIX® AQUA contact lenses bilaterally (same product in both eyes) on a daily wear basis for 1 week. In Phase 2, participants wore AIR OPTIX® COLORS and FRESHLOOK® COLORBLENDS contact lenses contralaterally (different product in each eye) on a daily wear basis for 4 weeks.
- Conditions
- Myopia
- Being tested
- Lotrafilcon B contact lens, Lotrafilcon B contact lens with color, Phemfilcon A contact lens with color
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lotrafilcon B contact lensDevice
Also called AIR OPTIX® AQUA
Silicone hydrogel contact lens
Lotrafilcon B contact lens with colorDevice
Also called AIR OPTIX® COLORS
Silicone hydrogel contact lens with color
Phemfilcon A contact lens with colorDevice
Also called FRESHLOOK® COLORBLENDS
Hydrogel contact lens with color
| Study group | Role | What they receive |
|---|---|---|
| AIR OPTIX® AQUA | Other | Lotrafilcon B contact lenses worn in both eyes on a daily wear basis for one week in Phase 1. Receives: Device: Lotrafilcon B contact lens |
| AIR OPTIX® COLORS | Experimental | Lotrafilcon B contact lens with color randomly assigned to one eye, with phemfilcon A contact lens with color in the fellow eye for contralateral wear. Both products worn on a daily wear basis for 4 weeks in Phase 2. A replacement phemfilcon A lens was dispensed at the Week 2 visit. Receives: Device: Lotrafilcon B contact lens with color |
| FRESHLOOK® COLORBLENDS | Active comparator | Phemfilcon A contact lens with color randomly assigned to one eye, with lotrafilcon B contact lens with color in the fellow eye for contralateral wear. Both products worn on a daily wear basis for 4 weeks in Phase 2. A replacement phemfilcon A lens was dispensed at the Week 2 visit. Receives: Device: Phemfilcon A contact lens with color |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Measured: Phase 2: Up to Week 4
Corneal Staining
Measured: Phase 2: Up to Week 4
Conjunctival Staining
Measured: Phase 2: Up to Week 4
Surface Regularity Index (SRI)
Measured: Up to Phase 2, Week 4
Surface Asymmetry Index (SAI)
Measured: Up to Phase 2, Week 4
Subjective ratings
Measured: Phase 2: Up to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- CIBA VISION
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Waterloo
- Responsible party
- Sponsor
- Investigators
- Desmond Fonn, MOptom, FAAO, Principal investigator, University of Waterloo Centre for Contact Lens ResearchLyndon Jones, PhD, FCOptom, FAAO, Principal investigator, University of Waterloo Centre for Contact Lens Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01338402
- Sponsor's protocol ID
- P-368-C-108
- Other IDs
- P/363/10/C
- Status last verified
- Feb 2014
- First submitted
- 15 Apr 2011
- Last updated
- 20 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance of AIR OPTIX® COLORS
- ClinicalTrials.gov ID
- NCT01338402
- Acronym / sponsor ID
- P-368-C-108
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- CIBA VISIONIndustry (pharma, biotech, devices)
- Collaborators
- University of Waterloo
- Study start
- Apr 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 19 Apr 2011 (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 study was to assess the ocular response to and performance of the cosmetically printed silicone hydrogel contact lens AIR OPTIX® COLORS compared to FRESHLOOK® COLORBLENDS.
Detailed description
The study was conducted in two phases. Phase 1 was an adaptation phase where participants wore AIR OPTIX® AQUA contact lenses bilaterally (same product in both eyes) on a daily wear basis for 1 week. In Phase 2, participants wore AIR OPTIX® COLORS and FRESHLOOK® COLORBLENDS contact lenses contralaterally (different product in each eye) on a daily wear basis for 4 weeks.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AIR OPTIX® AQUA | Other | Device: Lotrafilcon B contact lensLotrafilcon B contact lenses worn in both eyes on a daily wear basis for one week in Phase 1. |
| AIR OPTIX® COLORS | Experimental | Device: Lotrafilcon B contact lens with colorLotrafilcon B contact lens with color randomly assigned to one eye, with phemfilcon A contact lens with color in the fellow eye for contralateral wear. Both products worn on a daily wear basis for 4 weeks in Phase 2. A replacement phemfilcon A lens was dispensed at the Week 2 visit. |
| FRESHLOOK® COLORBLENDS | Active comparator | Device: Phemfilcon A contact lens with colorPhemfilcon A contact lens with color randomly assigned to one eye, with lotrafilcon B contact lens with color in the fellow eye for contralateral wear. Both products worn on a daily wear basis for 4 weeks in Phase 2. A replacement phemfilcon A lens was dispensed at the Week 2 visit. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Full legal capacity to volunteer;
- Read and sign information and consent letter;
- Willing and able to follow instructions and maintain the appointment schedule;
- Ocular examination in the last two years;
- Currently wears soft contact lenses on a daily wear basis;
Key exclusion criteria (8 listed)
- Any ocular disease;
- Any systemic condition that may affect a study outcome variable;
- Any systemic or topical medications that may affect ocular health;
- Known sensitivity to the diagnostic pharmaceuticals used in the study;
- Unable to achieve an acceptable fit with the study 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 lensAlso: AIR OPTIX® AQUASilicone hydrogel contact lens | Device | AIR OPTIX® AQUA |
| Lotrafilcon B contact lens with colorAlso: AIR OPTIX® COLORSSilicone hydrogel contact lens with color | Device | AIR OPTIX® COLORS |
| Phemfilcon A contact lens with colorAlso: FRESHLOOK® COLORBLENDSHydrogel contact lens with color | Device | FRESHLOOK® COLORBLENDS |
Primary outcome
Visual Acuity
Time frame: Phase 2: Up to Week 4
Corneal Staining
Time frame: Phase 2: Up to Week 4
Conjunctival Staining
Time frame: Phase 2: Up to Week 4
Surface Regularity Index (SRI)
Time frame: Up to Phase 2, Week 4
Surface Asymmetry Index (SAI)
Time frame: Up to Phase 2, Week 4
Subjective ratings
Time frame: Phase 2: Up to Week 4
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 20 Feb 2014.
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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.
Desmond Fonn, MOptom, FAAO principal investigator
University of Waterloo Centre for Contact Lens Research
Lyndon Jones, PhD, FCOptom, FAAO principal investigator
University of Waterloo Centre for Contact Lens Research
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, Lotrafilcon B contact lens with color and Phemfilcon A contact lens with color in people with Myopia, 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 7 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 20 Feb 2014. 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: Phase 2: Up to Week 4). The study lists 6 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 20 Feb 2014.