PresbyopiaNCT01254760

Comparison of Two Multifocal Contact Lenses Worn on a Daily Disposable Basis

A study testing Nelfilcon A multifocal contact lens, investigational and Nelfilcon A multifocal contact lens, commercial in people with Presbyopia and Myopia, run by CIBA VISION.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this trial is to evaluate and compare the clinical performance of two multifocal contact lenses. Read more about this study

Who is it for?: Ages 41 to 68 years
Conditions the study is for: Presbyopia, Myopia
What is being tested?: Nelfilcon A multifocal contact lens, investigational and Nelfilcon A multifocal contact lens, commercial
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 79 participants
Where: No sites listed yet
Study dates: Dec 2010to Jan 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 41 to 68 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 41 to 68 (inclusive).
Spectacle add between +0.75 and +2.75D (inclusive).
Habitual spectacle prescription ≤ 1.00DC (cyl).
Other protocol-defined inclusion criteria may apply.

Who cannot join

Eye injury or surgery within twelve weeks of enrollment.
Pre-existing ocular irritation that would preclude contact lens fitting.
Currently enrolled in a clinical trial.
Prior refractive surgery.
Other protocol-defined exclusion criteria may apply.

About this study

The purpose of this trial is to evaluate and compare the clinical performance of two multifocal contact lenses.

Conditions: Presbyopia, Myopia
Being tested: Nelfilcon A multifocal contact lens, investigational, Nelfilcon A multifocal contact lens, commercial
Medical subject headings: Presbyopia, Myopia

What participants receive

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

Nelfilcon A multifocal contact lens, investigationalDevice
Investigational, soft, multifocal contact lens for daily wear, daily disposable use.
Nelfilcon A multifocal contact lens, commercialDevice
Also called Focus® DAILIES® Progressive
Commercially marketed, soft, multifocal contact lens FDA-approved for daily wear, daily disposable use.

Study groups in NCT01254760
Study group	Role	What they receive
Investigational multifocal / Commercial multifocal	Other	Investigational multifocal contact lenses worn first, with commercial multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days. Receives: Device: Nelfilcon A multifocal contact lens, investigational; Device: Nelfilcon A multifocal contact lens, commercial
Commercial multifocal / Investigational multifocal	Other	Commercial multifocal contact lenses worn first, with investigational multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days. Receives: Device: Nelfilcon A multifocal contact lens, investigational; Device: Nelfilcon A multifocal contact lens, commercial

What is being measured

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

End of Day Comfort
End of day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Measured: 5 days of wear, lenses replaced daily
End of Day Dryness
End of day dryness was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.
Measured: 5 days of wear, lenses replaced daily
Handling at Removal
Handling at removal was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Handling at removal was measured on a 10-point scale, with 1 being poor/difficult and 10 being excellent/easy.
Measured: 5 days of wear, lenses replaced daily
Overall Vision
Overall vision was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Measured: 5 days of wear, lenses replaced daily

Secondary outcomes (1)

Overall Fit
Overall lens fit was assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was assessed by eye and graded on a 5-point scale, with 2=unacceptably loose, 1= acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight
Measured: Day 5, lenses replaced daily

Timeline

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

Dec 2010Jan 2011

First posted7 Dec 2010 (estimated)
Study startDec 2010
Primary completionJan 2011
Study completionJan 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 PresbyopiaStudies 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: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01254760
Sponsor's protocol ID: P-416-C-001 Sub 04
Status last verified: Jan 2012
First submitted: 3 Dec 2010
Last updated: 10 Jul 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

Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
Presbyopia

All Presbyopia 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: Comparison of Two Multifocal Contact Lenses Worn on a Daily Disposable Basis
ClinicalTrials.gov ID: NCT01254760
Acronym / sponsor ID: P-416-C-001 Sub 04
Conditions: Presbyopia, Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 79 participants (actual)
Lead sponsor: CIBA VISIONIndustry (pharma, biotech, devices)
Study start: Dec 2010
Primary completion: Jan 2011 (actual)
Study completion: Jan 2011 (actual)
First posted: 7 Dec 2010 (estimated)
Results: Posted 17 Feb 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 trial is to evaluate and compare the clinical performance of two multifocal contact lenses.

Study design

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

Arm	Type	Receives
Investigational multifocal / Commercial multifocal	Other	Device: Nelfilcon A multifocal contact lens, investigational, Device: Nelfilcon A multifocal contact lens, commercialInvestigational multifocal contact lenses worn first, with commercial multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.
Commercial multifocal / Investigational multifocal	Other	Device: Nelfilcon A multifocal contact lens, investigational, Device: Nelfilcon A multifocal contact lens, commercialCommercial multifocal contact lenses worn first, with investigational multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.

Who may qualify

Ages: 41 to 68 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age 41 to 68 (inclusive).
Spectacle add between +0.75 and +2.75D (inclusive).
Habitual spectacle prescription ≤ 1.00DC (cyl).
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (5 listed)

Eye injury or surgery within twelve weeks of enrollment.
Pre-existing ocular irritation that would preclude contact lens fitting.
Currently enrolled in a clinical trial.
Prior refractive surgery.
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
Nelfilcon A multifocal contact lens, investigationalInvestigational, soft, multifocal contact lens for daily wear, daily disposable use.	Device	Commercial multifocal / Investigational multifocal, Investigational multifocal / Commercial multifocal
Nelfilcon A multifocal contact lens, commercialAlso: Focus® DAILIES® ProgressiveCommercially marketed, soft, multifocal contact lens FDA-approved for daily wear, daily disposable use.	Device	Commercial multifocal / Investigational multifocal, Investigational multifocal / Commercial multifocal

Primary outcome

End of Day Comfort
Time frame: 5 days of wear, lenses replaced daily
End of day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.
End of Day Dryness
Time frame: 5 days of wear, lenses replaced daily
End of day dryness was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.
Handling at Removal
Time frame: 5 days of wear, lenses replaced daily
Handling at removal was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Handling at removal was measured on a 10-point scale, with 1 being poor/difficult and 10 being excellent/easy.
Overall Vision
Time frame: 5 days of wear, lenses replaced daily
Overall vision was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.

1 secondary outcome

Overall Fit
Time frame: Day 5, lenses replaced daily

Results and safety

Results posted to the registry on 17 Feb 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
Investigational Multifocal / Commercial Multifocal	34	34
Commercial Multifocal / Investigational Multifocal	38	38

Primary outcome: End of Day Comfort

Time frame: 5 days of wear, lenses replaced daily. Mean (Standard Deviation). Unit: Units on a scale

Measure	Nelfilcon A Investigational n = 71	Nelfilcon A Commercial n = 71
Value	7.7 (2.2)	7.2 (2.3)

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.

Primary outcome: End of Day Dryness

Time frame: 5 days of wear, lenses replaced daily. Mean (Standard Deviation). Unit: Units on a Scale

Measure	Nelfilcon A Investigational n = 71	Nelfilcon A Commercial n = 71
Value	7.2 (2.5)	6.9 (2.5)

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.

Primary outcome: Handling at Removal

Time frame: 5 days of wear, lenses replaced daily. Mean (Standard Deviation). Unit: Units on a Scale

Measure	Nelfilcon A Investigational n = 71	Nelfilcon A Commercial n = 70
Value	8.7 (1.6)	8.2 (2.1)

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.

Primary outcome: Overall Vision

Time frame: 5 days of wear, lenses replaced daily. Mean (Standard Deviation). Unit: Units on a Scale

Measure	Nelfilcon A Investigational n = 70	Nelfilcon A Commercial n = 71
Value	7.2 (1.9)	6.2 (2.1)

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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected for the duration of the trial: 53 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nelfilcon A Investigational	0 of 77 (0%)	0 of 77 (0%)	Not reported
Nelfilcon A Commercial	0 of 77 (0%)	0 of 77 (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 Presbyopia

Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
Presbyopia

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 multifocal contact lens, investigational and Nelfilcon A multifocal contact lens, commercial in people with Presbyopia and 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 4 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 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 17 Feb 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?

End of Day Comfort (time frame: 5 days of wear, lenses replaced daily). The study lists 4 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 NCT01254760.

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.