MyopiaNCT01445652

A Lifestyle Investigation With Spectacles and Daily Disposable Contact Lenses in Young Patients

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

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study was to evaluate the relative benefits of daily disposable contact lenses versus spectacles in young adults. Read more about this study

Who is it for?: Ages 13 to 19 years
Conditions the study is for: Myopia
What is being tested?: nelfilcon A contact lens and Spectacles
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 113 participants
Where: 1 siteUnited Kingdom
Study dates: Sep 2011to Jun 2012
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 13 to 19 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Understands rights as a research subject and willing and able to sign a Statement of Informed Consent, or if under 18, parent or guardian understands rights and is willing and able to sign a Statement of Informed Consent.
Willing and able to follow the protocol.
Currently wearing spectacles full-time (at least five days per week, eight hours per day).
Has never worn contact lenses (more than one day) before.
Agrees to not participate in other clinical research for the duration of this study.
Can attain at least 6/9 in each eye with the study optical correction.

Show all 11Show fewer

Can be fitted with study lenses in the available power range (contact lens group) or can select a satisfactory spectacle lens frame and lenses (spectacle group).
Willing and able to wear the study lenses or spectacles for a minimum of five days per week, eight hours per day.
Owns or has regular access to a mobile phone and is familiar with SMS text messaging.
Has an up-to-date and functional pair of spectacles at time of enrollment.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Has an ocular or systemic disorder that would normally contraindicate contact lens wear.
Is using any topical medication such as eye drops or ointment.
Has had corneal refractive surgery.
Has had cataract surgery.
Has diabetes.
Has taken part in other clinical research within two weeks of starting the study.
Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Eurolens Research
Manchester, M13 9PT

Other trials in United Kingdom

About this study

The purpose of this study was to evaluate the relative benefits of daily disposable contact lenses versus spectacles in young adults.

Conditions: Myopia
Being tested: nelfilcon A contact lens, Spectacles
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
Also called DAILIES AQUACOMFORT PLUS
Commercially marketed, single vision, soft contact lens for daily disposable wear
SpectaclesOther
Spectacles per current prescription

Study groups in NCT01445652
Study group	Role	What they receive
nelfilcon A	Experimental	Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months Receives: Device: nelfilcon A contact lens
Spectacles	Active comparator	Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months Receives: Other: Spectacles

What is being measured

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

Subjective Happiness With Correction Type
Participant responded to an SMS message: "Please rate your happiness (H) and vision (V) with your [contact lenses/spectacles]: 1=very poor; 2=poor; 3=neither; 4=good; and 5=very good. eg H2V4. Please send N if in you are not wearing [contact lenses/spectacles]."
Measured: Month 6
Subjective Vision With Correction Type
Participant responded to an SMS message: "Please rate your happiness (H) and vision (V) with your [contact lenses/spectacles]: 1=very poor; 2=poor; 3=neither; 4=good; and 5=very good. eg H2V4. Please send N if in you are not wearing [contact lenses/spectacles]."
Measured: Month 6

Timeline

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

Sep 2011Jun 2012

First posted4 Oct 2011 (estimated)
Study startSep 2011
Primary completionJun 2012
Study completionJun 2012

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: 113 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01445652
Sponsor's protocol ID: P-370-C-091 / CB11-500
Status last verified: Sep 2013
First submitted: 30 Sep 2011
Last updated: 19 Sep 2013
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

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

All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Lifestyle Investigation With Spectacles and Daily Disposable Contact Lenses in Young Patients
ClinicalTrials.gov ID: NCT01445652
Acronym / sponsor ID: P-370-C-091 / CB11-500
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 113 participants (actual)
Lead sponsor: CIBA VISIONIndustry (pharma, biotech, devices)
Collaborators: University of Manchester
Study start: Sep 2011
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 4 Oct 2011 (estimated)
Results: Posted 9 Sep 2013

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 was to evaluate the relative benefits of daily disposable contact lenses versus spectacles in young adults.

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 lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months
Spectacles	Active comparator	Other: SpectaclesSpectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months

Who may qualify

Ages: 13 to 19 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (11 listed)

Understands rights as a research subject and willing and able to sign a Statement of Informed Consent, or if under 18, parent or guardian understands rights and is willing and able to sign a Statement of Informed Consent.
Willing and able to follow the protocol.
Currently wearing spectacles full-time (at least five days per week, eight hours per day).
Has never worn contact lenses (more than one day) before.
Agrees to not participate in other clinical research for the duration of this study.

Key exclusion criteria (7 listed)

Has an ocular or systemic disorder that would normally contraindicate contact lens wear.
Is using any topical medication such as eye drops or ointment.
Has had corneal refractive surgery.
Has had cataract surgery.
Has diabetes.

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: DAILIES AQUACOMFORT PLUSCommercially marketed, single vision, soft contact lens for daily disposable wear	Device	nelfilcon A
SpectaclesSpectacles per current prescription	Other	Spectacles

Primary outcome

Subjective Happiness With Correction Type
Time frame: Month 6
Participant responded to an SMS message: "Please rate your happiness (H) and vision (V) with your [contact lenses/spectacles]: 1=very poor; 2=poor; 3=neither; 4=good; and 5=very good. eg H2V4. Please send N if in you are not wearing [contact lenses/spectacles]."
Subjective Vision With Correction Type
Time frame: Month 6
Participant responded to an SMS message: "Please rate your happiness (H) and vision (V) with your [contact lenses/spectacles]: 1=very poor; 2=poor; 3=neither; 4=good; and 5=very good. eg H2V4. Please send N if in you are not wearing [contact lenses/spectacles]."

Results and safety

Results posted to the registry on 9 Sep 2013, 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	57	47
Spectacles	53	50

Primary outcome: Subjective Happiness With Correction Type

Time frame: Month 6. Mean (Standard Deviation). Unit: Units on a Scale

Measure	Nelfilcon A n = 14	Spectacles n = 21
Value	4.92 (0.3)	4.50 (0.9)

Population analysed: This reporting group includes all participants who sent in an SMS response.

Primary outcome: Subjective Vision With Correction Type

Time frame: Month 6. Mean (Standard Deviation). Unit: Units on a scale

Measure	Nelfilcon A n = 14	Spectacles n = 21
Value	4.5 (0.7)	4.5 (0.8)

Population analysed: This reporting group includes all participants who sent in an SMS response.

Adverse events

Time frame: Adverse events were collected for the duration of the study (9 months). An adverse event was defined as any unfavourable or unintended sign or symptom associated with the use of a contact lens, but not necessarily caused by the contact lens.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nelfilcon A	0 of 57 (0%)	4 of 57 (7%)	Not reported
Spectacles	0 of 53 (0%)	0 of 53 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 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.

Philip Morgan, PhD MCOptom FAAO FBCLA principal investigator

University of Manchester

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 Spectacles in people with Myopia, run by CIBA VISION at 1 site in United Kingdom.

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 11 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 19 Sep 2013. 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 Kingdom. 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 9 Sep 2013). 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?

Subjective Happiness With Correction Type (time frame: Month 6). The study lists 2 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 NCT01445652.

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 19 Sep 2013.