MyopiaNCT01070381

Daily Disposable Toric Comparative Trial in Europe

A study testing nelfilcon A contact lens and ocufilcon D 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 study is to investigate the subjective and objective performance of two daily disposable lenses for wearers with astigmatism. Read more about this study

Who is it for?: Any age
Conditions the study is for: Myopia, Astigmatism
What is being tested?: nelfilcon A contact lens and ocufilcon D contact lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 220 participants
Where: No sites listed yet
Study dates: Jan 2010to Mar 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

Current soft contact lens wearers able to be fit with soft toric lenses in the protocol-specified parameters.
Achieve 0.5 or better distance visual acuity in each eye at time of dispense.
Achieve acceptable or optimal fit in each eye at time of dispense.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Habitual daily disposable contact lens wearer.
Sleeps in contact lenses overnight.
Currently enrolled in an ophthalmic clinical trial.
Other protocol-defined exclusion criteria may apply.

About this study

The purpose of this study is to investigate the subjective and objective performance of two daily disposable lenses for wearers with astigmatism.

Conditions: Myopia, Astigmatism
Being tested: nelfilcon A contact lens, ocufilcon D 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
Commercially marketed, toric, soft contact lens for daily disposable wear
ocufilcon D contact lensDevice
Commercially marketed, toric, soft contact lens for daily disposable wear

Study groups in NCT01070381
Study group	Role	What they receive
nelfilcon A / ocufilcon D	Other	Nelfilcon A contact lenses worn first, with ocufilcon D contact 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: ocufilcon D contact lens
ocufilcon D / nelfilcon A	Other	Ocufilcon D contact lenses worn first, with nelfilcon A contact 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: ocufilcon D contact lens

What is being measured

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

Overall Comfort
Overall Comfort, as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall comfort is measured 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.

Jan 2010Mar 2010

First posted18 Feb 2010 (estimated)
Study startJan 2010
Primary completionMar 2010
Study completionMar 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: 220 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01070381
Sponsor's protocol ID: P-346-C-008
Status last verified: Jan 2012
First submitted: 16 Feb 2010
Last updated: 13 Dec 2013
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

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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Daily Disposable Toric Comparative Trial in Europe
ClinicalTrials.gov ID: NCT01070381
Acronym / sponsor ID: P-346-C-008
Conditions: Myopia, Astigmatism
Study type: Interventional
Recruitment status: Completed
Enrolment: 220 participants (actual)
Lead sponsor: CIBA VISIONIndustry (pharma, biotech, devices)
Study start: Jan 2010
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 18 Feb 2010 (estimated)
Results: Posted 24 Mar 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 investigate the subjective and objective performance of two daily disposable lenses for wearers with astigmatism.

Study design

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

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

Who may qualify

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

Key inclusion criteria (4 listed)

Current soft contact lens wearers able to be fit with soft toric lenses in the protocol-specified parameters.
Achieve 0.5 or better distance visual acuity in each eye at time of dispense.
Achieve acceptable or optimal fit in each eye at time of dispense.
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (4 listed)

Habitual daily disposable contact lens wearer.
Sleeps in contact lenses overnight.
Currently enrolled in an ophthalmic clinical trial.
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 contact lensCommercially marketed, toric, soft contact lens for daily disposable wear	Device	nelfilcon A / ocufilcon D, ocufilcon D / nelfilcon A
ocufilcon D contact lensCommercially marketed, toric, soft contact lens for daily disposable wear	Device	nelfilcon A / ocufilcon D, ocufilcon D / nelfilcon A

Primary outcome

Overall Comfort
Time frame: 1 week of wear
Overall Comfort, as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall comfort is measured on a 10-point scale, with 1 being poor and 10 being excellent.

Results and safety

Results posted to the registry on 24 Mar 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 / Ocufilcon D	109	109
Ocufilcon D / Nelfilcon A	107	107

Primary outcome: Overall Comfort

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

Measure	Nelfilcon A n = 213	Ocufilcon D n = 213
Value	7.6 (1.9)	7.6 (1.9)

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 = 87 days. Individual exposure = 2 weeks (1 week per product). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nelfilcon A	0 of 217 (0%)	16 of 217 (7.4%)	Not reported
Ocufilcon D	0 of 216 (0%)	27 of 216 (12.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2013.
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 ocufilcon D 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 4 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 13 Dec 2013. 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 24 Mar 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 Comfort (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 NCT01070381.

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 13 Dec 2013.