MyopiaNCT01797783

Clinical Evaluation of the Safety and Efficacy of a New Multifocal Contact Lens

A study testing Nelfilcon A multifocal contact lens with comfort additive and Nelfilcon A multifocal contact lens in people with Myopia and Ametropia, 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 demonstrate substantial equivalence of the new DAILIES® AquaComfort Plus® Multifocal (DACP MF) contact lens to the commercially available Focus® DAILIES® Progressives (FDP) contact lens. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myopia, Ametropia, Presbyopia
What is being tested?: Nelfilcon A multifocal contact lens with comfort additive and Nelfilcon A multifocal contact lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 83 participants
Where: No sites listed yet
Study dates: Feb 2013to Apr 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

Sign Informed Consent Document.
Presbyopic and require a spectacle add of up to and including 3.00 diopters (D).
Currently wear soft contact lenses.
Willing and able to wear multifocal contact lenses in both eyes within the available range of powers for this trial and comply with the wearing and replacement schedule.
Manifest cylinder less than or equal to 1.00 D.
Able to achieve best corrected visual acuity (BCVA) of 20/25 or better (Snellen) in each eye at distance (as determined by manifest refraction).
Able to achieve distance visual acuity of 20/40 (Snellen) or better in each eye with study lenses and deem subjective vision as satisfactory at time of dispense.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment.
Any use of systemic or ocular medications for which contact lens wear could be contraindicated.
History of corneal or refractive surgery.
Biomicroscopy findings greater than Grade 2 at baseline.
A pathologically dry eye that precludes contact lens wear.
Monocular (only one eye with functional vision).

Show all 11Show fewer

Wear habitual contact lenses on an extended wear schedule (any number of nights of overnight wear on a regular basis).
History of intolerance or hypersensitivity to any component of the investigational products.
Concurrent participation in a contact lens or contact lens care product clinical trial or within the previous 30 days.
Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment.
Other protocol-defined exclusion criteria may apply.

About this study

Conditions: Myopia, Ametropia, Presbyopia, Refractive Error
Being tested: Nelfilcon A multifocal contact lens with comfort additive, Nelfilcon A multifocal contact lens
Keywords: Myopia, Presbyopia, Refractive error, Contact lenses, Multifocal
Medical subject headings: Myopia, Refractive Errors, Presbyopia

What participants receive

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

Nelfilcon A multifocal contact lens with comfort additiveDevice
Nelfilcon A multifocal contact lensDevice

Study groups in NCT01797783
Study group	Role	What they receive
DAILIES® AquaComfort Plus® Multifocal	Experimental	Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis Receives: Device: Nelfilcon A multifocal contact lens with comfort additive
Focus® DAILIES® Progressives	Active comparator	Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis Receives: Device: Nelfilcon A multifocal contact lens

What is being measured

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

Subjective Overall Vision
The participant was instructed to, "Please rate the aggregate of distance, intermediate, and near vision quality. Fill in the circle below the number that indicates your selection. Rate eyes together, marking only 1 circle for both eyes. Higher numbers mean better vision." The response was recorded on a continuous scale from 1-10 (1=poor, 10=excellent).
Measured: Up to Day 30

Secondary outcomes (2)

Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses
Visual Acuity was tested while reading a chart at 20-foot equivalent distance from the participant with both eyes together. The Snellen fraction compares the participant's result to the result expected from the 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity.
Measured: Up to Day 30
Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses
Visual Acuity was tested while reading charts at a distance of 40 cm from the participant with both eyes together. The Snellen fraction 20/20 represents 'normal' near vision. A larger denominator indicates a lower visual acuity.
Measured: Up to Day 30

Timeline

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

Feb 2013Apr 2013

First posted25 Feb 2013 (estimated)
Study startFeb 2013
Primary completionApr 2013
Study completionApr 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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 83 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01797783
Sponsor's protocol ID: C-12-054
Status last verified: Apr 2014
First submitted: 21 Feb 2013
Last updated: 23 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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Study at a glance

From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of the Safety and Efficacy of a New Multifocal Contact Lens
ClinicalTrials.gov ID: NCT01797783
Acronym / sponsor ID: C-12-054
Conditions: Myopia, Ametropia, Presbyopia, Refractive Error
Keywords: Myopia, Presbyopia, Refractive error, Contact lenses, Multifocal
Study type: Interventional
Recruitment status: Completed
Enrolment: 83 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Feb 2013
Primary completion: Apr 2013 (actual)
Study completion: Apr 2013 (actual)
First posted: 25 Feb 2013 (estimated)
Results: Posted 23 May 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

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

Arm	Type	Receives
DAILIES® AquaComfort Plus® Multifocal	Experimental	Device: Nelfilcon A multifocal contact lens with comfort additiveNelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
Focus® DAILIES® Progressives	Active comparator	Device: Nelfilcon A multifocal contact lensNelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis

Who may qualify

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

Key inclusion criteria (8 listed)

Sign Informed Consent Document.
Presbyopic and require a spectacle add of up to and including 3.00 diopters (D).
Currently wear soft contact lenses.
Willing and able to wear multifocal contact lenses in both eyes within the available range of powers for this trial and comply with the wearing and replacement schedule.
Manifest cylinder less than or equal to 1.00 D.

Key exclusion criteria (11 listed)

Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment.
Any use of systemic or ocular medications for which contact lens wear could be contraindicated.
History of corneal or refractive surgery.
Biomicroscopy findings greater than Grade 2 at baseline.
A pathologically dry eye that precludes contact lens wear.

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 with comfort additive	Device	DAILIES® AquaComfort Plus® Multifocal
Nelfilcon A multifocal contact lens	Device	Focus® DAILIES® Progressives

Primary outcome

Subjective Overall Vision
Time frame: Up to Day 30
The participant was instructed to, "Please rate the aggregate of distance, intermediate, and near vision quality. Fill in the circle below the number that indicates your selection. Rate eyes together, marking only 1 circle for both eyes. Higher numbers mean better vision." The response was recorded on a continuous scale from 1-10 (1=poor, 10=excellent).

2 secondary outcomes

Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses
Time frame: Up to Day 30
Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses
Time frame: Up to Day 30

Results and safety

Results posted to the registry on 23 May 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
DAILIES® AquaComfort Plus® Multifocal	52	50
Focus® DAILIES® Progressives	27	26

Primary outcome: Subjective Overall Vision

Time frame: Up to Day 30. Mean (Standard Deviation). Unit: Units on a scale

Measure	DAILIES® AquaComfort Plus® Multifocal n = 50	Focus® DAILIES® Progressives n = 26
Dispense (Day 0) (n=49,26)	8.7 (1.1)	8.4 (1.2)
Day 3 (n=49,26)	8.4 (1.3)	7.5 (1.7)
Day 14 (n=50,26)	8.6 (1.2)	7.7 (1.9)
Day 30 (n=50,26)	8.5 (1.1)	7.6 (1.9)

Population analysed: This analysis population includes all randomized and dispensed participants who completed the study. No imputation was used for 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: An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign in subjects, users, or other persons, whether or not related to the medical device. AEs were collected for the duration of the study (2 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DAILIES® AquaComfort Plus® Multifocal	0 of 52 (0%)	0 of 52 (0%)	Not reported
Focus® DAILIES® Progressives	0 of 27 (0%)	0 of 27 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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
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Active, not recruiting
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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.

Justin Webb, O.D. study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A study testing Nelfilcon A multifocal contact lens with comfort additive and Nelfilcon A multifocal contact lens in people with Myopia and Ametropia, 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 11 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 23 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 23 May 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 Overall Vision (time frame: Up to 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 NCT01797783.

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 23 May 2014.