MyopiaNCT01295905

Prospective Study of an Investigational Daily Disposable Contact Lens

A study testing delefilcon A contact lens and narafilcon B 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 performance of an investigational daily disposable contact lens. Read more about this study

Who is it for?: Any age
Conditions the study is for: Myopia
What is being tested?: delefilcon A contact lens and narafilcon B contact lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: No sites listed yet
Study dates: Jan 2011to May 2011
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

Subjects with normal eyes who are not using any ocular medications.
Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
Willing and able to wear spherical contact lenses for at least 5 days per week.
Willing and able to wear spherical contact lenses within the available range of powers of -1.00 diopter(D) to -6.00D in 0.25D steps.
Best spectacle-corrected visual acuity greater than or equal to 20/25.
Manifest cylinder less than or equal to 0.75D.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Any active anterior segment ocular disease that would contraindicate contact lens wear.
Any use of systemic medications for which contact lens wear could be contraindicated as determined by the investigator.
History of refractive surgery or irregular cornea.
History of pathologically dry eye.
Eye injury within twelve weeks immediately prior to enrollment for this trial.
Currently enrolled in any clinical trial.
Participation in a contact lens or contact lens care product clinical trial within the previous 30 days.
Other protocol-defined exclusion criteria may apply.

About this study

The purpose of this study is to evaluate the performance of an investigational daily disposable contact lens.

Conditions: Myopia
Being tested: delefilcon A contact lens, narafilcon 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.

delefilcon A contact lensDevice
Investigational silicone hydrogel, single vision soft contact lens
narafilcon B contact lensDevice
Commercially marketed silicone hydrogel, single vision soft contact lens

Study groups in NCT01295905
Study group	Role	What they receive
delefilcon A	Experimental	Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months. Receives: Device: delefilcon A contact lens
narafilcon B	Active comparator	Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months. Receives: Device: narafilcon B contact lens

What is being measured

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

Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity
Each eye tested individually while reading a chart distant to the participant in normal lighting. Visual acuity was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. Visual acuity is reported as the number of eyes achieving 20/20 Snellen acuity or better.
Measured: 3 months of wear, lenses replaced daily

Secondary outcomes (3)

Overall Vision
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Measured: 3 months of wear, lenses replaced daily
Overall Comfort
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Measured: 3 months of wear, lenses replaced daily
Overall Handling
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Measured: 3 months of wear, lenses replaced daily

Timeline

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

Jan 2011May 2011

First posted15 Feb 2011 (estimated)
Study startJan 2011
Primary completionMay 2011
Study completionMay 2011

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: Single blind
Who is masked: Participant
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01295905
Sponsor's protocol ID: P-347-C-004
Status last verified: May 2012
First submitted: 11 Feb 2011
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

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
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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
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 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Study of an Investigational Daily Disposable Contact Lens
ClinicalTrials.gov ID: NCT01295905
Acronym / sponsor ID: P-347-C-004
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: CIBA VISIONIndustry (pharma, biotech, devices)
Study start: Jan 2011
Primary completion: May 2011 (actual)
Study completion: May 2011 (actual)
First posted: 15 Feb 2011 (estimated)
Results: Posted 20 Jun 2012

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 an investigational daily disposable contact lens.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
delefilcon A	Experimental	Device: delefilcon A contact lensInvestigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
narafilcon B	Active comparator	Device: narafilcon B contact lensCommercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.

Who may qualify

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

Key inclusion criteria (7 listed)

Subjects with normal eyes who are not using any ocular medications.
Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
Willing and able to wear spherical contact lenses for at least 5 days per week.
Willing and able to wear spherical contact lenses within the available range of powers of -1.00 diopter(D) to -6.00D in 0.25D steps.
Best spectacle-corrected visual acuity greater than or equal to 20/25.

Key exclusion criteria (8 listed)

Any active anterior segment ocular disease that would contraindicate contact lens wear.
Any use of systemic medications for which contact lens wear could be contraindicated as determined by the investigator.
History of refractive surgery or irregular cornea.
History of pathologically dry eye.
Eye injury within twelve weeks immediately prior to enrollment for this trial.

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
delefilcon A contact lensInvestigational silicone hydrogel, single vision soft contact lens	Device	delefilcon A
narafilcon B contact lensCommercially marketed silicone hydrogel, single vision soft contact lens	Device	narafilcon B

Primary outcome

Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity
Time frame: 3 months of wear, lenses replaced daily
Each eye tested individually while reading a chart distant to the participant in normal lighting. Visual acuity was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. Visual acuity is reported as the number of eyes achieving 20/20 Snellen acuity or better.

3 secondary outcomes

Overall Vision
Time frame: 3 months of wear, lenses replaced daily
Overall Comfort
Time frame: 3 months of wear, lenses replaced daily
Overall Handling
Time frame: 3 months of wear, lenses replaced daily

Results and safety

Results posted to the registry on 20 Jun 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Delefilcon A	60	58
Narafilcon B	30	30

Primary outcome: Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity

Time frame: 3 months of wear, lenses replaced daily. Number. Unit: eyes

Measure	Delefilcon A n = 58	Narafilcon B n = 30
Value	111	58

Population analysed: Per protocol.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected for the duration of the study: 19-JAN-2011 to 20-MAY-2011.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Delefilcon A	0 of 60 (0%)	0 of 60 (0%)	Not reported
Narafilcon B	1 of 30 (3.3%)	0 of 30 (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 delefilcon A contact lens and narafilcon B 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 7 inclusion and 8 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 20 Jun 2012). 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?

Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity (time frame: 3 months of wear, lenses replaced daily). 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 NCT01295905.

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.