MyopiaNCT02175199
A Comparison of Two Color Contact Lenses in Habitual Clear Contact Lens Wearers
A study testing Lotrafilcon B contact lenses with color printing and Phemfilcon A contact lenses with color printing in people with Myopia, run by Alcon Research.
Trial summary
The purpose of this study is to evaluate the comfort of color contact lenses in a population of clear contact lens wearers who have an interest in wearing color contact lenses. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- Lotrafilcon B contact lenses with color printing and Phemfilcon A contact lenses with color printing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Sep 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Willing to sign an Informed Consent Document or Assent, if applicable.
- Vision correctable to 20/30 Snellen (feet) or better in each eye at distance with pre-study contact lenses.
- Manifest cylinder (at screening) less than or equal to 0.75 diopters (D) in each eye.
- Successful wear of clear/handling tint, single-vision spherical, bi-weekly/ monthly replacement soft contact lenses in both eyes during the past 2 months for a minimum of 5 days per week and 8 hours per day.
- Requires spherical contact lenses within the available range of powers (i.e.,-1.50D to -5.00D in 0.25D steps).
- Interested in wearing contact lenses that change the appearance of the color of the eyes.
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current).
- History of herpetic keratitis.
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated including any use of topical ocular medications that would require instillation during contact lens wear, except for rewetting drops.
- Corneal vascularization greater than 1 millimeter (mm) of penetration.
- 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 12Show fewer
- Monovision and monocular (only 1 eye with functional vision) or fit with only 1 lens.
- Anisometropia ≥1.50D (study contact lens prescription).
- History of intolerance or hypersensitivity to any component of the test articles.
- Eye injury or ocular or intra-ocular surgery within the last 6 months (excluding placement of punctal plugs).
- Participation in any clinical study within 30 days of Visit 1.
- Other protocol-specified exclusion criteria may apply.
About this study
The purpose of this study is to evaluate the comfort of color contact lenses in a population of clear contact lens wearers who have an interest in wearing color contact lenses.
- Conditions
- Myopia
- Being tested
- Lotrafilcon B contact lenses with color printing, Phemfilcon A contact lenses with color printing
- Keywords
- Contact lens, Vision care, Daily wear, Color contact lens
- 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 lenses with color printingDevice
Also called AIR OPTIX® COLORS
Phemfilcon A contact lenses with color printingDevice
Also called FreshLook® COLORBLENDS®
| Study group | Role | What they receive |
|---|---|---|
| AIR OPTIX COLORS | Experimental | Lotrafilcon B contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days. Receives: Device: Lotrafilcon B contact lenses with color printing |
| FreshLook COLORBLENDS | Active comparator | Phemfilcon A contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days with a 2-week replacement. Receives: Device: Phemfilcon A contact lenses with color printing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lens Comfort Likert Response at Day 30
Subject indicated agreement with the following statement, "These lenses provided the same excellent comfort at the end of the month as they did at the beginning of the month" using a 4-point Likert scale, where 1=Strongly disagree, 2=Disagree; 3=Agree; 4=Strongly agree. The Top 2 responses (agree, strongly agree) were calculated and reported as a percentage of all responses. Both eyes were rated together. This outcome measure was prespecified for the AIR OPTIX COLORS arm only.
Measured: Day 30
Secondary outcomes (2)
Lens Comfort Likert Response at Day 14
Subject indicated agreement with the following statement, "These lenses provided the same excellent comfort at the end of two weeks as they did at the beginning of the two weeks" using a 4-point Likert scale, where 1=Strongly disagree, 2=Disagree; 3=Agree; 4=Strongly agree. The Top 2 responses (agree, strongly agree) were calculated and reported as a percentage of all responses. Both eyes were rated together. This outcome measure is prespecified for the AIR OPTIX COLORS arm only.
Measured: Day 14
Lens Comfort 1-10 Scale Response
Subject was instructed, "Please rate your comfort with the study lenses," using a scale from 1-10, where 1=poor and 10=excellent. Both eyes were rated together.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2014
- Study completionSep 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.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Brand Lead, GCRA, Vision Care, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175199
- Sponsor's protocol ID
- M-14-008
- Status last verified
- Sep 2015
- First submitted
- 24 Jun 2014
- Last updated
- 14 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. 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
- NCT02175199
- Acronym / sponsor ID
- M-14-008
- Conditions
- Myopia
- Keywords
- Contact lens, Vision care, Daily wear, Color contact lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 26 Jun 2014 (estimated)
- Results
- Posted 14 Oct 2015
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 is to evaluate the comfort of color contact lenses in a population of clear contact lens wearers who have an interest in wearing color 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 lenses with color printingLotrafilcon B contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days. |
| FreshLook COLORBLENDS | Active comparator | Device: Phemfilcon A contact lenses with color printingPhemfilcon A contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days with a 2-week replacement. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Willing to sign an Informed Consent Document or Assent, if applicable.
- Vision correctable to 20/30 Snellen (feet) or better in each eye at distance with pre-study contact lenses.
- Manifest cylinder (at screening) less than or equal to 0.75 diopters (D) in each eye.
- Successful wear of clear/handling tint, single-vision spherical, bi-weekly/ monthly replacement soft contact lenses in both eyes during the past 2 months for a minimum of 5 days per week and 8 hours per day.
- Requires spherical contact lenses within the available range of powers (i.e.,-1.50D to -5.00D in 0.25D steps).
Key exclusion criteria (12 listed)
- Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current).
- History of herpetic keratitis.
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated including any use of topical ocular medications that would require instillation during contact lens wear, except for rewetting drops.
- Corneal vascularization greater than 1 millimeter (mm) of penetration.
- 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 lenses with color printingAlso: AIR OPTIX® COLORS | Device | AIR OPTIX COLORS |
| Phemfilcon A contact lenses with color printingAlso: FreshLook® COLORBLENDS® | Device | FreshLook COLORBLENDS |
Primary outcome
Lens Comfort Likert Response at Day 30
Time frame: Day 30
Subject indicated agreement with the following statement, "These lenses provided the same excellent comfort at the end of the month as they did at the beginning of the month" using a 4-point Likert scale, where 1=Strongly disagree, 2=Disagree; 3=Agree; 4=Strongly agree. The Top 2 responses (agree, strongly agree) were calculated and reported as a percentage of all responses. Both eyes were rated together. This outcome measure was prespecified for the AIR OPTIX COLORS arm only.
2 secondary outcomes
Lens Comfort Likert Response at Day 14
Time frame: Day 14
Lens Comfort 1-10 Scale Response
Time frame: Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
- 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.
Global Brand Lead, GCRA, Vision Care study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A study testing Lotrafilcon B contact lenses with color printing and Phemfilcon A contact lenses with color printing in people with Myopia, 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 7 inclusion and 12 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 14 Oct 2015. 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 14 Oct 2015). 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?
Lens Comfort Likert Response at Day 30 (time frame: Day 30). 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 14 Oct 2015.