MyopiaNCT00953407

Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Lens Wearers

A study testing Nelfilcon A contact lens, Narafilcon A contact lens and Etafilcon 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.

Official record

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Trial summary

The purpose of this trial is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of 5 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, Narafilcon 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: 128 participants
Where: No sites listed yet
Study dates: Jul 2009to Sep 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 spherical, soft contact lenses replaced at intervals of 2 weeks or monthly.
Habitually wear lenses for at least 8 hours per day, 4 days per week, for at least the past 6 months.
Report 2 or more qualifying symptoms with current contact lenses with a frequency of "frequently" or "all the time"
Able to achieve VA of at least 20/40 in each eye with habitual correction and with study lenses at dispense.
Other protocol 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 medications for which contact lens wear could be contraindicated as determined by the investigator.
History of corneal refractive surgery.
Cylinder correction greater than 1.00 D.
Current monovision contact lens wearers.
Other protocol inclusion/exclusion criteria may apply.

About this study

The purpose of this trial is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of 5 different daily disposable contact lenses.

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

Study groups in NCT00953407
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
Etafilcon A	Active comparator	Etafilcon A contact lens Receives: Device: Etafilcon A contact lens
Omafilcon A	Active comparator	Omafilcon A contact lens Receives: Device: Omafilcon A contact lens
Hilafilcon B	Active comparator	Hilafilcon B contact lens Receives: Device: Hilafilcon B 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, was reported by the subject 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 all the time. 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.

Jul 2009Sep 2009

First posted6 Aug 2009 (estimated)
Study startJul 2009
Primary completionSep 2009
Study completionSep 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: 128 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00953407
Sponsor's protocol ID: P-337-C-027
Status last verified: Jan 2012
First submitted: 8 Jul 2009
Last updated: 10 Jul 2012
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 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 Lens Wearers
ClinicalTrials.gov ID: NCT00953407
Acronym / sponsor ID: P-337-C-027
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 128 participants (actual)
Lead sponsor: CIBA VISIONIndustry (pharma, biotech, devices)
Study start: Jul 2009
Primary completion: Sep 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 6 Aug 2009 (estimated)
Results: Posted 1 Nov 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 trial is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of 5 different daily disposable contact lenses.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

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
Etafilcon A	Active comparator	Device: Etafilcon A contact lensEtafilcon A contact lens
Omafilcon A	Active comparator	Device: Omafilcon A contact lensOmafilcon A contact lens
Hilafilcon B	Active comparator	Device: Hilafilcon B contact lensHilafilcon B contact lens

Who may qualify

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

Key inclusion criteria (5 listed)

Currently wear spherical, soft contact lenses replaced at intervals of 2 weeks or monthly.
Habitually wear lenses for at least 8 hours per day, 4 days per week, for at least the past 6 months.
Report 2 or more qualifying symptoms with current contact lenses with a frequency of "frequently" or "all the time"
Able to achieve VA of at least 20/40 in each eye with habitual correction and with study lenses at dispense.
Other protocol 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 medications for which contact lens wear could be contraindicated as determined by the investigator.
History of corneal 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
Etafilcon A contact lensDaily disposable contact lens worn in a daily wear, daily disposable mode	Device	Etafilcon A
Omafilcon A contact lensDaily disposable contact lens worn in a daily wear, daily disposable mode	Device	Omafilcon A
Hilafilcon B contact lensDaily disposable contact lens worn in a daily wear, daily disposable mode	Device	Hilafilcon B

Primary outcome

Lens Awareness
Time frame: 4 weeks of wear
Lens awareness, as interpreted by the subject, was reported by the subject 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 all the time. 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 1 Nov 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	26	25
Narafilcon A	25	24
Etafilcon A	26	25
Omafilcon A	25	23
Hilafilcon B	24	23

Primary outcome: Lens Awareness

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

Measure	Nelfilcon A n = 25	Narafilcon A n = 24	Etafilcon A n = 24	Omafilcon A n = 23	Hilafilcon B n = 23
Value	16 (2.3)	12 (2.8)	11 (3.1)	9 (2.5)	13 (3.1)

Population analysed: Per protocol. Analysis excluded major protocol deviations as determined by masked review.

Adverse events

Time frame: 8-1/2 weeks, 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 26 (0%)	0 of 26 (0%)	Not reported
Narafilcon A	0 of 25 (0%)	0 of 25 (0%)	Not reported
Etafilcon A	0 of 26 (0%)	0 of 26 (0%)	Not reported
Omafilcon A	0 of 25 (0%)	0 of 25 (0%)	Not reported
Hilafilcon B	0 of 24 (0%)	0 of 24 (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
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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
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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.

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, Narafilcon A contact lens and Etafilcon 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 1 Nov 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 NCT00953407.

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.