MyopiaNCT01635933

A Comparison of AIR OPTIX® COLORS Versus FRESHLOOK® COLORBLENDS

A study testing Lotrafilcon B contact lens with color and Phemfilcon A contact lens with color in people with Myopia, run by Alcon Research.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study was to evaluate the overall comfort of AIR OPTIX® COLORS compared to FRESHLOOK® COLORBLENDS in habitual wearers of the FRESHLOOK® COLORBLENDS . 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 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: 370 participants
Where: No sites listed yet
Study dates: Jun 2012to Sep 2012
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

Able and willing to sign the Informed Consent document. If under legal age of consent, legally authorized representative must sign also Informed Consent document.
Able to achieve visual acuity of at least 20/30 (Snellen) in each eye at distance with contact lenses and best corrected visual acuity (BCVA) ≥ 20/25 in each eye.
Manifest cylinder less than or equal to 0.75 diopters (within the previous year) in each eye.
Successful wear of FRESHLOOK® COLORBLENDS spherical soft contact lenses in both eyes (in the protocol-specified colors) during the past three months for a minimum of 5 days per week and 8 hours per day.
History of at least 5 days of successful use with both lenses (minimum of 8 hours/day) of one of the protocol-specified lens care solutions/multi-purpose solutions (MPS).
Other protocol-specified inclusion criteria may apply.

Who cannot join

Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the test articles or affect the results of this study.
Wears habitual lenses in an extended wear modality (sleeping in lenses overnight / not removing lenses on a daily basis).
Monovision, monocular (only one eye with functional vision) or fit with only one lens.
History of intolerance or hypersensitivity to any component of the test articles.
Use of any over-the-counter or prescribed topical ocular medications within the previous 7 days (excluding rewetting drops).
Moderate or severe corneal edema, corneal vascularization, corneal staining, injection, tarsal abnormalities, "other" complications; and any corneal infiltrates.

Show all 10Show fewer

Current or history of ocular infection, severe inflammation, or disease within previous 6 months.
Any systemic disease (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions.
Participation in any investigational clinical study within previous 30 days.
Other protocol-defined exclusion criteria may apply.

About this study

Official title: A Comparison of a Colored Silicone Hydrogel Lens Versus a Colored HEMA Lens

The purpose of this study was to evaluate the overall comfort of AIR OPTIX® COLORS compared to FRESHLOOK® COLORBLENDS in habitual wearers of the FRESHLOOK® COLORBLENDS .

Conditions: Myopia
Being tested: Lotrafilcon B contact lens with color, Phemfilcon A contact lens with color
Keywords: contact lenses, color contact lenses, myopia
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 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 groups in NCT01635933
Study group	Role	What they receive
AIR OPTIX® COLORS	Experimental	Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. 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 in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 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 Comfort
Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.
Measured: Up to Day 28

Secondary outcomes (2)

Subjective Rating of Overall Vision
Overall vision, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.
Measured: Up to Day 28
Proportion of Subjects Preferring Study Lens (Strongly or Somewhat)
Participants were asked to compare the study lenses to their habitual lenses using a 5-point scale: strongly prefer study lenses, somewhat prefer study lenses, no preference, somewhat prefer habitual lenses, and strongly prefer habitual lenses, where 'study lenses' refer to either test or control depending on the treatment group. Proportion of subjects preferring study lens is reported as the percentage of participants who strongly or somewhat preferred the study lens.
Measured: Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2012Sep 2012

First posted10 Jul 2012 (estimated)
Study startJun 2012
Primary completionSep 2012
Study completionSep 2012

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: 370 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01635933
Sponsor's protocol ID: C-12-005
Status last verified: Apr 2014
First submitted: 5 Jul 2012
Last updated: 9 May 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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All Myopia trials

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 a Colored Silicone Hydrogel Lens Versus a Colored HEMA Lens
ClinicalTrials.gov ID: NCT01635933
Acronym / sponsor ID: C-12-005
Conditions: Myopia
Keywords: contact lenses, color contact lenses, myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 370 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Jun 2012
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 10 Jul 2012 (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 the overall comfort of AIR OPTIX® COLORS compared to FRESHLOOK® COLORBLENDS in habitual wearers of the FRESHLOOK® COLORBLENDS .

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 in daily wear modality for 4 weeks. 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 in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 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)

Able and willing to sign the Informed Consent document. If under legal age of consent, legally authorized representative must sign also Informed Consent document.
Able to achieve visual acuity of at least 20/30 (Snellen) in each eye at distance with contact lenses and best corrected visual acuity (BCVA) ≥ 20/25 in each eye.
Manifest cylinder less than or equal to 0.75 diopters (within the previous year) in each eye.
Successful wear of FRESHLOOK® COLORBLENDS spherical soft contact lenses in both eyes (in the protocol-specified colors) during the past three months for a minimum of 5 days per week and 8 hours per day.
History of at least 5 days of successful use with both lenses (minimum of 8 hours/day) of one of the protocol-specified lens care solutions/multi-purpose solutions (MPS).

Key exclusion criteria (10 listed)

Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the test articles or affect the results of this study.
Wears habitual lenses in an extended wear modality (sleeping in lenses overnight / not removing lenses on a daily basis).
Monovision, monocular (only one eye with functional vision) or fit with only one lens.
History of intolerance or hypersensitivity to any component of the test articles.
Use of any over-the-counter or prescribed topical ocular medications within the previous 7 days (excluding rewetting drops).

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 Comfort
Time frame: Up to Day 28
Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.

2 secondary outcomes

Subjective Rating of Overall Vision
Time frame: Up to Day 28
Proportion of Subjects Preferring Study Lens (Strongly or Somewhat)
Time frame: Day 28

Results and safety

Results posted to the registry on 28 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AIR OPTIX® COLORS	178	176
FRESHLOOK® COLORBLENDS	185	177

Primary outcome: Subjective Rating of Overall Comfort

Time frame: Up to Day 28. Mean (Standard Deviation). Unit: Units on a scale

Measure	AIR OPTIX® COLORS n = 178	FRESHLOOK® COLORBLENDS n = 185
Day 14 (n=175,181)	8.7 (1.7)	8.6 (1.8)
Day 28 (n=176,176)	8.7 (1.7)	8.5 (1.7)

Population analysed: The analysis population includes all enrolled and dispensed participants who had at least one study visit after being dispensed with study lenses (N=178,185). No imputation was used for the missing values. Here, "n" is the number of participants with non-missing values at the specific time point for each arm group.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events (AE) were collected for the duration of the study (3 months). AEs were obtained as solicited comments from subjects and as observations by the study Investigator as outlined in the study protocol.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AIR OPTIX® COLORS	1 of 178 (0.6%)	0 of 178 (0%)	Not reported
FRESHLOOK® COLORBLENDS	2 of 185 (1.1%)	0 of 185 (0%)	Not reported

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.

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
Recruiting
Mobility Performance in Daily Activities Among Children Wearing Spectacle Lenses
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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, 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 Comfort (time frame: Up to Day 28). 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 NCT01635933.

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 7 Nov 2026.