MyopiaNCT00987623

Clinical Evaluation of Two Daily Disposable Lenses in Neophytes

A study testing nelfilcon A contact lens and narafilcon A contact lens in people with Myopia, run by CIBA VISION at 1 site in United States.

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 evaluate the performance of two daily disposable contact lenses in a population of neophytes (new wearers). Read more about this study

Who is it for?: Ages Up to 45 years
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: 326 participants
Where: 1 siteUnited States
Study dates: Aug 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 Up to 45 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

No previous contact lens experience or attempts to try contact lenses (neophytes).
Currently wearing spectacles or needing vision correction in both eyes.
No older than 45 years of age.
Able to achieve visual acuity of at least 20/40 in each eye with study lenses in the available parameters.
Interested in wearing contact lenses.
Willing to wear study lenses for at least 8 hours/day, at least 5 days/week.
Other protocol-defined inclusion/exclusion criteria may apply.

Who cannot join

Eye injury or surgery within twelve weeks prior to enrollment.
Pre-existing ocular irritation that would preclude contact lens fitting.
Previous corneal or refractive surgery.
Currently enrolled in any Clinical Trial.
Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

The Research Intelligence Group (TRiG)
Fort Washington, Pennsylvania, 19034

Other trials in United States

About this study

The purpose of this study is to evaluate the performance of two daily disposable contact lenses in a population of neophytes (new wearers).

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
Commercially marketed, hydrogel, single-vision contact lens for daily wear, daily disposable use.
narafilcon A contact lensDevice
Commercially marketed, silicone hydrogel, single-vision contact lens for daily wear, daily disposable use.

Study groups in NCT00987623
Study group	Role	What they receive
nelfilcon A	Experimental	Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week. Receives: Device: nelfilcon A contact lens
narafilcon A	Active comparator	Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week. Receives: Device: narafilcon A contact lens

What is being measured

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

Overall Lens Satisfaction
Overall Lens Satisfaction, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall lens satisfaction was measured on a 10-point scale, with 1 being Poor and 10 being Excellent
Measured: 1 week

Timeline

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

Aug 2009Dec 2009

First posted1 Oct 2009 (estimated)
Study startAug 2009
Primary completionDec 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: 326 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00987623
Sponsor's protocol ID: P-337-C-031
Status last verified: Jan 2012
First submitted: 29 Sep 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?

See locations

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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: Clinical Evaluation of Two Daily Disposable Lenses in Neophytes
ClinicalTrials.gov ID: NCT00987623
Acronym / sponsor ID: P-337-C-031
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 326 participants (actual)
Lead sponsor: CIBA VISIONIndustry (pharma, biotech, devices)
Study start: Aug 2009
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 1 Oct 2009 (estimated)
Results: Posted 13 Jan 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 evaluate the performance of two daily disposable contact lenses in a population of neophytes (new wearers).

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 lensCommercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
narafilcon A	Active comparator	Device: narafilcon A contact lensCommercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.

Who may qualify

Ages: Up to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (7 listed)

No previous contact lens experience or attempts to try contact lenses (neophytes).
Currently wearing spectacles or needing vision correction in both eyes.
No older than 45 years of age.
Able to achieve visual acuity of at least 20/40 in each eye with study lenses in the available parameters.
Interested in wearing contact lenses.

Key exclusion criteria (5 listed)

Eye injury or surgery within twelve weeks prior to enrollment.
Pre-existing ocular irritation that would preclude contact lens fitting.
Previous corneal or refractive surgery.
Currently enrolled in any Clinical Trial.
Other protocol-defined inclusion/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, hydrogel, single-vision contact lens for daily wear, daily disposable use.	Device	nelfilcon A
narafilcon A contact lensCommercially marketed, silicone hydrogel, single-vision contact lens for daily wear, daily disposable use.	Device	narafilcon A

Primary outcome

Overall Lens Satisfaction
Time frame: 1 week
Overall Lens Satisfaction, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall lens satisfaction was measured on a 10-point scale, with 1 being Poor and 10 being Excellent

Results and safety

Results posted to the registry on 13 Jan 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	145	140
Narafilcon A	154	151

Primary outcome: Overall Lens Satisfaction

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

Measure	Nelfilcon A n = 128	Narafilcon A n = 138
Value	7.9 (1.7)	7.9 (1.6)

Population analysed: Analysis conducted per protocol, with exclusions due to 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: 108 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nelfilcon A	0 of 151 (0%)	0 of 151 (0%)	Not reported
Narafilcon A	0 of 163 (0%)	0 of 163 (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
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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.

1 site in 1 country: see every site and its status.

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 at 1 site in United States.

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 7 inclusion and 5 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.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 13 Jan 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 Lens Satisfaction (time frame: 1 week). 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 NCT00987623.

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.