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
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.
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- 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