MyopiaNCT01035905

Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Daily Disposable Lens Wearers

A study testing Nelfilcon A contact lens and Narafilcon A 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 extent to which symptoms improve in symptomatic contact lens wearers when fit with one of two different daily disposable contact lenses. 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 A contact lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 63 participants
Where: No sites listed yet
Study dates: Sep 2009to Dec 2009
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 wear daily disposable, spherical, soft lens wearers (except the two study products) for at least the past 6 months.
Habitually wear lenses for at least 8 hours per day and 4 days per week.
Report 2 or more qualifying symptoms with current contact lenses.
Able to achieve visual acuity of at least 20/40 in each eye with habitual and with study lenses at dispense.
Other protocol-defined inclusion/exclusion criteria may apply.

Who cannot join

Eye injury or surgery within twelve weeks immediately prior to enrollment.
Currently enrolled in any clinical trial.
Any use of ocular medications, exclusive of contact lens rewetting drops.
History of corneal or refractive surgery.
Cylinder correction greater than 1.00 D
Current monovision contact lens wearers.
Other protocol-defined inclusion/exclusion criteria may apply.

About this study

The purpose of this study is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of two different daily disposable contact lenses.

Conditions: Myopia
Being tested: Nelfilcon A contact lens, Narafilcon A 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
Daily disposable contact lens worn in a daily wear, daily disposable mode
Narafilcon A contact lensDevice
Daily disposable contact lens worn in a daily wear, daily disposable mode

Study groups in NCT01035905
Study group	Role	What they receive
Nelfilcon A	Experimental	Nelfilcon A contact lens Receives: Device: Nelfilcon A contact lens
Narafilcon A	Active comparator	Narafilcon A contact lens Receives: Device: Narafilcon A contact lens

What is being measured

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

Lens Awareness
Lens awareness, as interpreted by the subject and reported by the subject in a questionnaire as a single, retrospective evaluation of 4-week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being always. Four-week ratings were compared to baseline ratings, and a negative difference (4 week minus baseline) represented an improvement.
Measured: 4 weeks of wear

Timeline

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

Sep 2009Dec 2009

First posted21 Dec 2009 (estimated)
Study startSep 2009
Primary completionNov 2009
Study completionDec 2009

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: Parallel groups
Masking: None (open label)
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01035905
Sponsor's protocol ID: P-337-C-030
Status last verified: Jan 2012
First submitted: 18 Dec 2009
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
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
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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: Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Daily Disposable Lens Wearers
ClinicalTrials.gov ID: NCT01035905
Acronym / sponsor ID: P-337-C-030
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: CIBA VISIONIndustry (pharma, biotech, devices)
Study start: Sep 2009
Primary completion: Nov 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 21 Dec 2009 (estimated)
Results: Posted 19 Oct 2010

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 extent to which symptoms improve in symptomatic contact lens wearers when fit with one of two different daily disposable contact lenses.

Study design

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

Arm	Type	Receives
Nelfilcon A	Experimental	Device: Nelfilcon A contact lensNelfilcon A contact lens
Narafilcon A	Active comparator	Device: Narafilcon A contact lensNarafilcon A contact lens

Who may qualify

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

Key inclusion criteria (5 listed)

Currently wear daily disposable, spherical, soft lens wearers (except the two study products) for at least the past 6 months.
Habitually wear lenses for at least 8 hours per day and 4 days per week.
Report 2 or more qualifying symptoms with current contact lenses.
Able to achieve visual acuity of at least 20/40 in each eye with habitual and with study lenses at dispense.
Other protocol-defined inclusion/exclusion criteria may apply.

Key exclusion criteria (7 listed)

Eye injury or surgery within twelve weeks immediately prior to enrollment.
Currently enrolled in any clinical trial.
Any use of ocular medications, exclusive of contact lens rewetting drops.
History of corneal or refractive surgery.
Cylinder correction greater than 1.00 D

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 lensDaily disposable contact lens worn in a daily wear, daily disposable mode	Device	Nelfilcon A
Narafilcon A contact lensDaily disposable contact lens worn in a daily wear, daily disposable mode	Device	Narafilcon A

Primary outcome

Lens Awareness
Time frame: 4 weeks of wear
Lens awareness, as interpreted by the subject and reported by the subject in a questionnaire as a single, retrospective evaluation of 4-week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being always. Four-week ratings were compared to baseline ratings, and a negative difference (4 week minus baseline) represented an improvement.

Results and safety

Results posted to the registry on 19 Oct 2010, 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	32	31
Narafilcon A	31	30

Primary outcome: Lens Awareness

Time frame: 4 weeks of wear. Number. Unit: Participants

Measure	Nelfilcon A n = 31	Narafilcon A n = 30
Value	8	9

Population analysed: Per Protocol

Adverse events

Time frame: 63 days, duration of the study. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nelfilcon A	0 of 32 (0%)	0 of 32 (0%)	Not reported
Narafilcon A	0 of 31 (0%)	0 of 31 (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 A 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 5 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 19 Oct 2010). 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?

Lens Awareness (time frame: 4 weeks 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 NCT01035905.

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.