MyopiaNCT01371539

Clinical Comparison of Two Multifocal Contact Lenses Made of Silicone Hydrogel Materials

A study testing Lotrafilcon B contact lens and Comfilcon A contact lens in people with Myopia and Presbyopia, run by CIBA VISION.

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 compare visual performance measures between two multifocal contact lenses on presbyopic wearers. Read more about this study

Who is it for?: Ages 35 years and older
Conditions the study is for: Myopia, Presbyopia
What is being tested?: Lotrafilcon B contact lens and Comfilcon A contact lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 109 participants
Where: No sites listed yet
Study dates: Jun 2011to Aug 2011
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 35 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

At least 35 years of age.
Spectacle add of +0.50 to +2.50 diopters (inclusive).
Currently wearing soft contact lenses at least 5 days per week and at least 8 hours per day.
Able to be fit in both eyes with soft multifocal lenses in available powers.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Eye injury or surgery within 12 weeks of enrollment in trial.
Currently enrolled in any clinical trial.
Astigmatism of 1.00 diopter or more.
Currently wearing excluded brands of multifocal lenses, as specified by protocol.
Other protocol-defined exclusion criteria may apply.

About this study

The purpose of this study was to compare visual performance measures between two multifocal contact lenses on presbyopic wearers.

Conditions: Myopia, Presbyopia
Being tested: Lotrafilcon B contact lens, Comfilcon A contact lens
Keywords: Myopia, Presbyopia
Medical subject headings: Myopia, Presbyopia

What participants receive

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

Lotrafilcon B contact lensDevice
Also called AIR OPTIX AQUA MULTIFOCAL
Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use.
Comfilcon A contact lensDevice
Also called Biofinity Multifocal
Commercially marketed (France), silicone hydrogel, multifocal contact lens for daily wear use.

Study groups in NCT01371539
Study group	Role	What they receive
Lotrafilcon B / Comfilcon A	Other	Lotrafilcon B contact lenses worn first, with comfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each. Receives: Device: Lotrafilcon B contact lens; Device: Comfilcon A contact lens
Comfilcon A / Lotrafilcon B	Other	Comfilcon A contact lenses worn first, with lotrafilcon B contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each. Receives: Device: Lotrafilcon B contact lens; Device: Comfilcon A contact lens

What is being measured

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

Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity
The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.
Measured: 1 week
Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity
The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal near eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.
Measured: 1 week

Timeline

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

Jun 2011Aug 2011

First posted13 Jun 2011 (estimated)
Study startJun 2011
Primary completionAug 2011
Study completionAug 2011

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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 109 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01371539
Sponsor's protocol ID: P-319-C-021
Status last verified: Jun 2012
First submitted: 9 Jun 2011
Last updated: 3 Aug 2012
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 3 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Comparison of Two Multifocal Contact Lenses Made of Silicone Hydrogel Materials
ClinicalTrials.gov ID: NCT01371539
Acronym / sponsor ID: P-319-C-021
Conditions: Myopia, Presbyopia
Keywords: Myopia, Presbyopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 109 participants (actual)
Lead sponsor: CIBA VISIONIndustry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Aug 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 13 Jun 2011 (estimated)
Results: Posted 3 Aug 2012

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 compare visual performance measures between two multifocal contact lenses on presbyopic wearers.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Lotrafilcon B / Comfilcon A	Other	Device: Lotrafilcon B contact lens, Device: Comfilcon A contact lensLotrafilcon B contact lenses worn first, with comfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.
Comfilcon A / Lotrafilcon B	Other	Device: Lotrafilcon B contact lens, Device: Comfilcon A contact lensComfilcon A contact lenses worn first, with lotrafilcon B contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.

Who may qualify

Ages: 35 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

At least 35 years of age.
Spectacle add of +0.50 to +2.50 diopters (inclusive).
Currently wearing soft contact lenses at least 5 days per week and at least 8 hours per day.
Able to be fit in both eyes with soft multifocal lenses in available powers.
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (5 listed)

Eye injury or surgery within 12 weeks of enrollment in trial.
Currently enrolled in any clinical trial.
Astigmatism of 1.00 diopter or more.
Currently wearing excluded brands of multifocal lenses, as specified by protocol.
Other protocol-defined exclusion criteria may apply.

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 lensAlso: AIR OPTIX AQUA MULTIFOCALCommercially marketed, silicone hydrogel, multifocal contact lens for daily wear use.	Device	Comfilcon A / Lotrafilcon B, Lotrafilcon B / Comfilcon A
Comfilcon A contact lensAlso: Biofinity MultifocalCommercially marketed (France), silicone hydrogel, multifocal contact lens for daily wear use.	Device	Comfilcon A / Lotrafilcon B, Lotrafilcon B / Comfilcon A

Primary outcome

Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity
Time frame: 1 week
The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.
Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity
Time frame: 1 week
The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal near eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.

Results and safety

Results posted to the registry on 3 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lotrafilcon B / Comfilcon A	53	53
Comfilcon A / Lotrafilcon B	51	50

Primary outcome: Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity

Time frame: 1 week. Mean (Standard Deviation). Unit: logMAR

Measure	Lotrafilcon B n = 98	Comfilcon A n = 101
Value	-0.00 (0.07)	0.00 (0.06)

Population analysed: The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.

Primary outcome: Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity

Time frame: 1 week. Mean (Standard Deviation). Unit: logMAR

Measure	Lotrafilcon B n = 98	Comfilcon A n = 102
Value	0.12 (0.10)	0.10 (0.12)

Adverse events

Time frame: Adverse events were collected for the duration of the study: 24-JUN-2011 to 16-AUG-2011.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lotrafilcon B	0 of 103 (0%)	0 of 103 (0%)	Not reported
Comfilcon A	0 of 104 (0%)	0 of 104 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2012.
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
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
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
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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.

Stacie Cummings, O.D. study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A study testing Lotrafilcon B contact lens and Comfilcon A contact lens in people with Myopia and Presbyopia, run by CIBA VISION.

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 5 inclusion and 5 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 3 Aug 2012. 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 3 Aug 2012). 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?

Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity (time frame: 1 week). The study lists 2 primary outcomes in all. 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 NCT01371539.

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 3 Aug 2012.