MyopiaNCT01362894

Clinical Comparison of Two Daily Disposable Toric Lenses

A study testing nelfilcon A contact lens and etafilcon A contact lens in people with Myopia and Astigmatism, 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 trial was to compare the performance of two contact lenses commercially available for people with astigmatism. 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?: nelfilcon A contact lens and etafilcon A contact lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 240 participants
Where: No sites listed yet
Study dates: May 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Sign written informed consent.
Germany: Be of legal age.
Current monthly or weekly toric soft lens wearer able to be fit in both eyes with soft toric lenses in the study parameters.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Eye injury or surgery within twelve weeks.
Pre-existing ocular irritation that would preclude contact lens fitting.
Currently enrolled in an ophthalmic clinical trial.
Wears contact lenses overnight while sleeping.
Habitual daily disposable contact lens wearer.
Monovision correction during the study.
Other protocol-defined exclusion criteria may apply.

About this study

The purpose of this trial was to compare the performance of two contact lenses commercially available for people with astigmatism.

Read the detailed description

This trial compared the performance of two commercialized daily disposable contact lenses in Germany.

Conditions: Myopia, Astigmatism
Being tested: nelfilcon A contact lens, etafilcon A contact lens
Medical subject headings: Myopia, Astigmatism

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 Focus® DAILIES® Toric
Commercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear.
etafilcon A contact lensDevice
Also called 1-DAY ACUVUE® MOIST® FOR ASTIGMATISM
Commercially marketed, etafilcon A, toric, soft contact lens for daily disposable wear.

Study groups in NCT01362894
Study group	Role	What they receive
nelfilcon A / etafilcon A	Other	Nelfilcon A lenses worn first, with etafilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each. Receives: Device: nelfilcon A contact lens; Device: etafilcon A contact lens
etafilcon A / nelfilcon A	Other	Etafilcon A lenses worn first, with nelfilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each. Receives: Device: nelfilcon A contact lens; Device: etafilcon A contact lens

What is being measured

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

Overall Vision
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.
Measured: 1 week, replacing lenses daily
Overall Comfort
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was rated on a 10-point scale, with 1 being poor and 10 being excellent.
Measured: 1 week, replacing lenses daily
Overall Handling
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was rated on a 10-point scale, with 1 being difficult and 10 being easy.
Measured: 1 week, replacing lenses daily
Overall Satisfaction
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.
Measured: 1 week, replacing lenses daily

Secondary outcomes (1)

Ease of Selecting Final Lens Power
As interpreted by the investigator at time of lens fitting and recorded on a questionnaire. Ease of selecting final lens power was rated on a 10-point scale, with 1 being difficult and 10 being easy.
Measured: Day 0

Timeline

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

May 2011Aug 2011

First posted1 Jun 2011 (estimated)
Study startMay 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: None (open label)
Enrolment: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01362894
Sponsor's protocol ID: P-346-C-013
Status last verified: Jul 2012
First submitted: 27 May 2011
Last updated: 9 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 9 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Comparison of Two Daily Disposable Toric Lenses
ClinicalTrials.gov ID: NCT01362894
Acronym / sponsor ID: P-346-C-013
Conditions: Myopia, Astigmatism
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: CIBA VISIONIndustry (pharma, biotech, devices)
Study start: May 2011
Primary completion: Aug 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 1 Jun 2011 (estimated)
Results: Posted 9 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 trial was to compare the performance of two contact lenses commercially available for people with astigmatism.

Detailed description

This trial compared the performance of two commercialized daily disposable contact lenses in Germany.

Study design

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

Arm	Type	Receives
nelfilcon A / etafilcon A	Other	Device: nelfilcon A contact lens, Device: etafilcon A contact lensNelfilcon A lenses worn first, with etafilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
etafilcon A / nelfilcon A	Other	Device: nelfilcon A contact lens, Device: etafilcon A contact lensEtafilcon A lenses worn first, with nelfilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.

Who may qualify

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

Key inclusion criteria (4 listed)

Sign written informed consent.
Germany: Be of legal age.
Current monthly or weekly toric soft lens wearer able to be fit in both eyes with soft toric lenses in the study parameters.
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (7 listed)

Eye injury or surgery within twelve weeks.
Pre-existing ocular irritation that would preclude contact lens fitting.
Currently enrolled in an ophthalmic clinical trial.
Wears contact lenses overnight while sleeping.
Habitual daily disposable contact lens wearer.

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: Focus® DAILIES® ToricCommercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear.	Device	etafilcon A / nelfilcon A, nelfilcon A / etafilcon A
etafilcon A contact lensAlso: 1-DAY ACUVUE® MOIST® FOR ASTIGMATISMCommercially marketed, etafilcon A, toric, soft contact lens for daily disposable wear.	Device	etafilcon A / nelfilcon A, nelfilcon A / etafilcon A

Primary outcome

Overall Vision
Time frame: 1 week, replacing lenses daily
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.
Overall Comfort
Time frame: 1 week, replacing lenses daily
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was rated on a 10-point scale, with 1 being poor and 10 being excellent.
Overall Handling
Time frame: 1 week, replacing lenses daily
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was rated on a 10-point scale, with 1 being difficult and 10 being easy.
Overall Satisfaction
Time frame: 1 week, replacing lenses daily
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.

1 secondary outcome

Ease of Selecting Final Lens Power
Time frame: Day 0

Results and safety

Results posted to the registry on 9 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
Nelfilcon A / Etafilcon A	119	119
Etafilcon A / Nelfilcon A	117	117

Primary outcome: Overall Vision

Time frame: 1 week, replacing lenses daily. Mean (Standard Deviation). Unit: Units on a scale

Measure	Nelfilcon A n = 226	Etafilcon A n = 228
Value	8.2 (1.7)	7.5 (2.1)

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: Overall Comfort

Time frame: 1 week, replacing lenses daily. Mean (Standard Deviation). Unit: Units on a scale

Measure	Nelfilcon A n = 227	Etafilcon A n = 229
Value	7.8 (1.8)	7.2 (2.0)

Primary outcome: Overall Handling

Time frame: 1 week, replacing lenses daily. Mean (Standard Deviation). Unit: Units on a scale

Measure	Nelfilcon A n = 227	Etafilcon A n = 229
Value	8.2 (1.8)	6.8 (2.2)

Primary outcome: Overall Satisfaction

Time frame: 1 week, replacing lenses daily. Mean (Standard Deviation). Unit: Units on a scale

Measure	Nelfilcon A n = 227	Etafilcon A n = 229
Value	7.7 (1.9)	6.9 (2.0)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected for the duration of the study: 20-May-2011 to 15-AUG-2011.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nelfilcon A	2 of 234 (0.9%)	0 of 234 (0%)	Not reported
Etafilcon A	0 of 235 (0%)	0 of 235 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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
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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.

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 etafilcon A contact lens in people with Myopia and Astigmatism, 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 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 9 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 9 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?

Overall Vision (time frame: 1 week, replacing lenses 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 NCT01362894.

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 9 Aug 2012.