MyopiaNCT01782482
A Comparison of Two Color Contact Lenses in Habitual Clear Contact Lens Wearers
A study testing Lotrafilcon B contact lens with color and Phemfilcon A contact lens with color in people with Myopia and Refractive Error, run by Alcon Research.
Trial summary
The purpose of this study was to evaluate overall satisfaction with AIR OPTIX® COLORS as compared to FRESHLOOK® COLORBLENDS contact lenses. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Myopia, Refractive Error
- What is being tested?
- 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
- 574 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Apr 2013
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Willing and able to sign Informed Consent Document. If under legal age of consent, legally authorized representative must also sign Informed Consent Document.
- Able to achieve best corrected visual acuity (BCVA) of 20/25 (Snellen) or better in each eye at distance.
- Manifest cylinder less than or equal to 0.75 diopter in each eye.
- Wear contact lenses within protocol-defined specifications.
- Require spherical contact lenses within the available range of powers.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Any eye condition that contraindicates contact lens wear.
- Any systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
- Moderate or severe ocular findings upon examination.
- Any use of systemic or ocular medications that could contraindicate contact lens wear, including use of topical ocular medications requiring instillation during contact lens wear, except for approved lubricating drops.
- Habitual lenses worn in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week or more) over the last 3 months prior to enrollment.
- Previous corneal or refractive surgery or irregular cornea.
Show all 10Show fewer
- Eye injury or surgery within the last 6 months (excluding placement of punctal plugs).
- Monovision and monocular subjects (only one eye with functional vision) or subjects fit with only one lens.
- History of intolerance or hypersensitivity to any component of the test articles.
- Other protocol-defined exclusion criteria may apply.
About this study
The purpose of this study was to evaluate overall satisfaction with AIR OPTIX® COLORS as compared to FRESHLOOK® COLORBLENDS contact lenses.
- Conditions
- Myopia, Refractive Error
- Being tested
- Lotrafilcon B contact lens with color, Phemfilcon A contact lens with color
- Keywords
- Color contact lenses, Refractive error, Myopia
- Medical subject headings
- Myopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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® COLORS | Experimental | Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day. Receives: Device: Lotrafilcon B contact lens with color |
| FRESHLOOK® COLORBLENDS | Active comparator | Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day. 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.
Subjective Rating of Overall Satisfaction
Overall satisfaction, as rated by the participant on a 10-point scale, with 1 being very dissatisfied to 10 being very satisfied. The participant rated both eyes together by providing one single rating.
Measured: Day 7
Secondary outcomes (1)
Positive Purchase Intent
As reported on a questionnaire in response to, "Assuming these lenses were at a price you would expect to pay, how likely would you be to purchase these lenses?" The binary 'positive' vs 'negative' response variable was derived from a 5-point Likert scale. Positive purchase intent is reported as the percentage of participants choosing "Definitely would purchase" or "Probably would purchase."
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionApr 2013
- Study completionApr 2013
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 574 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sharon Holden Thomas, O.D., Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782482
- Sponsor's protocol ID
- C-12-003
- Status last verified
- Mar 2014
- First submitted
- 31 Jan 2013
- Last updated
- 9 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Color Contact Lenses in Habitual Clear Contact Lens Wearers
- ClinicalTrials.gov ID
- NCT01782482
- Acronym / sponsor ID
- C-12-003
- Conditions
- Myopia, Refractive Error
- Keywords
- Color contact lenses, Refractive error, Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 574 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 4 Feb 2013 (estimated)
- Results
- Posted 28 Mar 2014
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 evaluate overall satisfaction with AIR OPTIX® COLORS as compared to FRESHLOOK® COLORBLENDS contact lenses.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIR OPTIX® COLORS | Experimental | Device: Lotrafilcon B contact lens with colorLotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day. |
| FRESHLOOK® COLORBLENDS | Active comparator | Device: Phemfilcon A contact lens with colorPhemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Willing and able to sign Informed Consent Document. If under legal age of consent, legally authorized representative must also sign Informed Consent Document.
- Able to achieve best corrected visual acuity (BCVA) of 20/25 (Snellen) or better in each eye at distance.
- Manifest cylinder less than or equal to 0.75 diopter in each eye.
- Wear contact lenses within protocol-defined specifications.
- Require spherical contact lenses within the available range of powers.
Key exclusion criteria (10 listed)
- Any eye condition that contraindicates contact lens wear.
- Any systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
- Moderate or severe ocular findings upon examination.
- Any use of systemic or ocular medications that could contraindicate contact lens wear, including use of topical ocular medications requiring instillation during contact lens wear, except for approved lubricating drops.
- Habitual lenses worn in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week or more) over the last 3 months prior to enrollment.
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 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
Subjective Rating of Overall Satisfaction
Time frame: Day 7
Overall satisfaction, as rated by the participant on a 10-point scale, with 1 being very dissatisfied to 10 being very satisfied. The participant rated both eyes together by providing one single rating.
1 secondary outcome
Positive Purchase Intent
Time frame: Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2014.
- 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.
Sharon Holden Thomas, O.D. study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A study testing Lotrafilcon B contact lens with color and Phemfilcon A contact lens with color in people with Myopia and Refractive Error, run by Alcon Research.
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 10 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 9 May 2014. Status can change between updates, so confirm with the study contact before making plans.
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 28 Mar 2014). 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?
Subjective Rating of Overall Satisfaction (time frame: Day 7). 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 9 May 2014; AzTrials last refreshed its copy on 26 Oct 2026.