MyopiaNCT01629693

Clinical Evaluation of Two Monthly Replacement Silicone Hydrogel Contact Lenses

A study testing Lotrafilcon B contact lenses and Comfilcon A contact lenses in people with Myopia and Astigmatism, 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 is to evaluate differences in the comfort at the end of the month between Air Optix® lenses versus Biofinity® lenses in habitual daily wear symptomatic soft contact lens wearers. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myopia, Astigmatism
What is being tested?: Lotrafilcon B contact lenses and Comfilcon A contact lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 398 participants
Where: No sites listed yet
Study dates: Jul 2013to Nov 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Must sign written informed consent document.
Currently wearing weekly/biweekly or monthly sphere or toric soft contact lenses (NOT including AIR OPTIX Aqua, AIR OPTIX NIGHT \& DAY Aqua, AIR OPTIX for Astigmatism, Biofinity Sphere, Biofinity Toric, or ProClear Toric soft contact lenses) bilaterrally (in both eyes) and have worn these lenses for at least 3 months, daily wear use only (no extended wear).
Symptomatic for contact lens-related ocular discomfort at the end of the lens wearing day.
Current contact lens prescription within the available parameters of both study products.
Able to achieve visual acuity (VA) of at least 6/7.5 (20/25) in each eye with study lenses in the available parameters.
Willing to wear study lenses for at least 4 hours/day and at least 5 days/week for the 1 month trial period.
Willing and able to follow instructions, study procedures and maintain the appointment schedule.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Neophytes and current wearers of AIR OPTIX Aqua, AIR OPTIX NIGHT \& DAY Aqua, AIR OPTIX for Astigmatism, Biofinity sphere, Biofinity Toric, or ProClear Toric soft contact lenses.
Any systemic or ocular disease or disorder (refractive disorder allowed and dry eye is permitted), complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
Recent (within 7 days of enrollment) or current ocular infections, active ocular inflammation, glaucoma or preauricular lymphadenopathy.
A history of ocular surgery/trauma within the last 6 months.
Topical or systemic antibiotics use within 7 days of enrollment.
Topical ocular or systemic corticosteroids use within 14 days of enrollment.
Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
Other protocol-defined exclusion criteria may apply.

About this study

Conditions: Myopia, Astigmatism
Being tested: Lotrafilcon B contact lenses, Comfilcon A contact lenses
Keywords: contact lenses, myopia, astigmatism
Medical subject headings: Myopia, Astigmatism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lotrafilcon B contact lensesDevice
Also called AIR OPTIX® AQUA, AIR OPTIX® for ASTIGMATISM
Silicone hydrogel contact lenses (sphere or toric) per subject's habitual prescription
Comfilcon A contact lensesDevice
Also called Biofinity® Sphere, Biofinity® Toric
Silicone hydrogel contact lenses (sphere or toric) per subject's habitual prescription

Study groups in NCT01629693
Study group	Role	What they receive
Air Optix	Experimental	Lotrafilcon B contact lenses worn bilaterally (in both eyes) for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis (removed nightly for cleaning and disinfection). Receives: Device: Lotrafilcon B contact lenses
Biofinity	Active comparator	Comfilcon A contact lenses worn bilaterally (in both eyes) for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis (removed nightly for cleaning and disinfection). Receives: Device: Comfilcon A contact lenses

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Likert Response: "I Can Comfortably Wear my Lenses" at Day 30
Overall comfort was assessed by the participant as a response to the questionnaire item 'I can comfortably wear my lenses', using a 10-point Likert scale, with 1=poor and 10=excellent.
Measured: Baseline, Day 30

Timeline

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

Jul 2013Nov 2013

First posted28 Jun 2012 (estimated)
Study startJul 2013
Primary completionNov 2013
Study completionNov 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.
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: 398 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01629693
Sponsor's protocol ID: A00973
Status last verified: Oct 2014
First submitted: 26 Jun 2012
Last updated: 6 Nov 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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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of Two Monthly Replacement Silicone Hydrogel Contact Lenses
ClinicalTrials.gov ID: NCT01629693
Acronym / sponsor ID: A00973
Conditions: Myopia, Astigmatism
Keywords: contact lenses, myopia, astigmatism
Study type: Interventional
Recruitment status: Completed
Enrolment: 398 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Jul 2013
Primary completion: Nov 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 28 Jun 2012 (estimated)
Results: Posted 6 Nov 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Air Optix	Experimental	Device: Lotrafilcon B contact lensesLotrafilcon B contact lenses worn bilaterally (in both eyes) for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis (removed nightly for cleaning and disinfection).
Biofinity	Active comparator	Device: Comfilcon A contact lensesComfilcon A contact lenses worn bilaterally (in both eyes) for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis (removed nightly for cleaning and disinfection).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Must sign written informed consent document.
Currently wearing weekly/biweekly or monthly sphere or toric soft contact lenses (NOT including AIR OPTIX Aqua, AIR OPTIX NIGHT \& DAY Aqua, AIR OPTIX for Astigmatism, Biofinity Sphere, Biofinity Toric, or ProClear Toric soft contact lenses) bilaterrally (in both eyes) and have worn these lenses for at least 3 months, daily wear use only (no extended wear).
Symptomatic for contact lens-related ocular discomfort at the end of the lens wearing day.
Current contact lens prescription within the available parameters of both study products.
Able to achieve visual acuity (VA) of at least 6/7.5 (20/25) in each eye with study lenses in the available parameters.

Key exclusion criteria (8 listed)

Neophytes and current wearers of AIR OPTIX Aqua, AIR OPTIX NIGHT \& DAY Aqua, AIR OPTIX for Astigmatism, Biofinity sphere, Biofinity Toric, or ProClear Toric soft contact lenses.
Any systemic or ocular disease or disorder (refractive disorder allowed and dry eye is permitted), complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
Recent (within 7 days of enrollment) or current ocular infections, active ocular inflammation, glaucoma or preauricular lymphadenopathy.
A history of ocular surgery/trauma within the last 6 months.
Topical or systemic antibiotics use within 7 days of 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 lensesAlso: AIR OPTIX® AQUA, AIR OPTIX® for ASTIGMATISMSilicone hydrogel contact lenses (sphere or toric) per subject's habitual prescription	Device	Air Optix
Comfilcon A contact lensesAlso: Biofinity® Sphere, Biofinity® ToricSilicone hydrogel contact lenses (sphere or toric) per subject's habitual prescription	Device	Biofinity

Primary outcome

Change From Baseline in Likert Response: "I Can Comfortably Wear my Lenses" at Day 30
Time frame: Baseline, Day 30
Overall comfort was assessed by the participant as a response to the questionnaire item 'I can comfortably wear my lenses', using a 10-point Likert scale, with 1=poor and 10=excellent.

Results and safety

Results posted to the registry on 6 Nov 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	193	188
Biofinity	188	178

Primary outcome: Change From Baseline in Likert Response: "I Can Comfortably Wear my Lenses" at Day 30

Time frame: Baseline, Day 30. Mean (Standard Deviation). Unit: units on a scale

Measure	Air Optix n = 179	Biofinity n = 168
Baseline	6.1 (2.2)	6.3 (2.1)
Change from Baseline at Day 30	1.5 (2.8)	1.4 (2.7)

Population analysed: This analysis population includes all participants who completed the protocol and had no major protocol violations.

Adverse events

Time frame: Adverse events (AEs) were collected from 10 Jul 2013 to 20 Nov 2013. AEs were obtained through volunteered and elicited comments from the participants.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Air Optix	1 of 193 (0.5%)	0 of 193 (0%)	Not reported
Biofinity	1 of 188 (0.5%)	0 of 188 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Recruiting
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Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
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Active, not recruiting
Effect of IOP Lowering on Progressive HM
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Recruiting
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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.

Jami Kern, Ph.D. study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A study testing Lotrafilcon B contact lenses and Comfilcon A contact lenses in people with Myopia and Astigmatism, 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 8 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 6 Nov 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 6 Nov 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?

Change From Baseline in Likert Response: "I Can Comfortably Wear my Lenses" at Day 30 (time frame: Baseline, Day 30). 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 NCT01629693.

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 6 Nov 2014.