MyopiaNCT01233076

Clinical Comparison of Two Daily Disposable Contact Lenses in a Population of Daily Disposable Contact Lens Wearers

A study testing Nelfilcon A contact lens and Narafilcon B contact lens in people with Myopia, run by CIBA VISION.

Completed

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

Trial summary

The purpose of this study is to evaluate the performance of two commercially marketed daily disposable contact lenses in a population of daily disposable contact lens wearers. Read more about this study

Who is it for?: Any age
Conditions the study is for: Myopia
What is being tested?: Nelfilcon A contact lens and Narafilcon B contact lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: No sites listed yet
Study dates: Oct 2010to Nov 2010
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Currently wearing daily disposable lenses in daily wear, daily disposable modality, except DAILIES AquaComfort Plus and 1-DAY ACUVUE TruEye.
Able to wear study lenses in the available powers from -1.00D to -6.00D.
Other protocol-defined inclusion/exclusion criteria may apply.

Who cannot join

Eye injury within twelve weeks of enrollment.
History of corneal or refractive surgery.
Pre-existing ocular irritation that would preclude contact lens fitting.
Currently enrolled in any clinical trial.
Currently wearing DAILIES AquaComfort Plus or 1-DAY ACUVUE TruEye lenses.
Monovision correction during the study.
Other protocol-defined inclusion/exclusion criteria may apply.

About this study

The purpose of this study is to evaluate the performance of two commercially marketed daily disposable contact lenses in a population of daily disposable contact lens wearers.

Conditions: Myopia
Being tested: Nelfilcon A contact lens, Narafilcon B 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.

Nelfilcon A contact lensDevice
Also called DAILIES AquaComfort Plus
Commercially marketed, spherical contact lens for daily wear, daily disposable use
Narafilcon B contact lensDevice
Also called 1-DAY ACUVUE TruEye
Commercially marketed (US), spherical contact lens for daily wear, daily disposable use

Study groups in NCT01233076
Study group	Role	What they receive
Nelfilcon A / Narafilcon B	Other	Nelfilcon A worn first, with narafilcon B worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week. Receives: Device: Nelfilcon A contact lens; Device: Narafilcon B contact lens
Narafilcon B / Nelfilcon A	Other	Narafilcon B worn first, with nelfilcon A worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week. Receives: Device: Nelfilcon A contact lens; Device: Narafilcon B contact lens

What is being measured

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

Overall Vision Quality
Overall vision quality, as interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear. Overall vision quality is evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Measured: 1 week of wear

Timeline

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

Oct 2010Nov 2010

First posted3 Nov 2010 (estimated)
Study startOct 2010
Primary completionNov 2010
Study completionNov 2010

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: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01233076
Sponsor's protocol ID: P-337-C-034
Status last verified: Jan 2012
First submitted: 1 Nov 2010
Last updated: 10 Jul 2012
Results posted: Yes, on ClinicalTrials.gov

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

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
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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
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
Hyperopia and Myopia

All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Comparison of Two Daily Disposable Contact Lenses in a Population of Daily Disposable Contact Lens Wearers
ClinicalTrials.gov ID: NCT01233076
Acronym / sponsor ID: P-337-C-034
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: CIBA VISIONIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 3 Nov 2010 (estimated)
Results: Posted 8 Sep 2011

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 performance of two commercially marketed daily disposable contact lenses in a population of daily disposable contact lens wearers.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Nelfilcon A / Narafilcon B	Other	Device: Nelfilcon A contact lens, Device: Narafilcon B contact lensNelfilcon A worn first, with narafilcon B worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.
Narafilcon B / Nelfilcon A	Other	Device: Nelfilcon A contact lens, Device: Narafilcon B contact lensNarafilcon B worn first, with nelfilcon A worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Currently wearing daily disposable lenses in daily wear, daily disposable modality, except DAILIES AquaComfort Plus and 1-DAY ACUVUE TruEye.
Able to wear study lenses in the available powers from -1.00D to -6.00D.
Other protocol-defined inclusion/exclusion criteria may apply.

Key exclusion criteria (7 listed)

Eye injury within twelve weeks of enrollment.
History of corneal or refractive surgery.
Pre-existing ocular irritation that would preclude contact lens fitting.
Currently enrolled in any clinical trial.
Currently wearing DAILIES AquaComfort Plus or 1-DAY ACUVUE TruEye lenses.

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
Nelfilcon A contact lensAlso: DAILIES AquaComfort PlusCommercially marketed, spherical contact lens for daily wear, daily disposable use	Device	Narafilcon B / Nelfilcon A, Nelfilcon A / Narafilcon B
Narafilcon B contact lensAlso: 1-DAY ACUVUE TruEyeCommercially marketed (US), spherical contact lens for daily wear, daily disposable use	Device	Narafilcon B / Nelfilcon A, Nelfilcon A / Narafilcon B

Primary outcome

Overall Vision Quality
Time frame: 1 week of wear
Overall vision quality, as interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear. Overall vision quality is evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.

Results and safety

Results posted to the registry on 8 Sep 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nelfilcon A / Narafilcon B	30	30
Narafilcon B / Nelfilcon A	30	30

Primary outcome: Overall Vision Quality

Time frame: 1 week of wear. Mean (Standard Deviation). Unit: units on a scale

Measure	Nelfilcon A n = 59	Narafilcon B n = 59
Value	8.2 (1.7)	8.7 (1.5)

Population analysed: Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Adverse events

Time frame: Adverse event data were collected for the duration of the trial: 41 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nelfilcon A	0 of 60 (0%)	0 of 60 (0%)	Not reported
Narafilcon B	0 of 60 (0%)	0 of 60 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 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
Hyperopia and Myopia

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Nelfilcon A contact lens and Narafilcon B contact lens in people with Myopia, 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 3 inclusion and 7 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 10 Jul 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 8 Sep 2011). 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?

Overall Vision Quality (time frame: 1 week of wear). 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 NCT01233076.

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 10 Jul 2012.