MyopiaNCT01362907

Clinical Comparison of Silicone Hydrogel and HEMA-based Daily Disposable Contact Lenses

A study testing Delefilcon 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.

Trial summary

The purpose of this trial was to compare the performance of an investigational daily disposable contact lens to a commercially available 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 Etafilcon A contact lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: No sites listed yet
Study dates: May 2011to Jun 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

Normal eyes with no use of 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 protocol-specified timeframe within the available range of powers (-1.00 D to -6.00D in 0.25D steps).
Visual acuity with study lenses 20/25 or better.
Cylinder less than or equal to 0.75 D.
Currently wearing daily disposable lenses.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Anterior segment infection, inflammation, or abnormality.
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.
Eye injury within twelve weeks immediately prior to enrollment for this trial.
Currently enrolled in any clinical trial.
Other protocol-defined exclusion criteria may apply.

About this study

The purpose of this trial was to compare the performance of an investigational daily disposable contact lens to a commercially available daily disposable contact lens.

Conditions: Myopia
Being tested: Delefilcon A contact lens, Etafilcon 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.

Delefilcon A contact lensDevice
Also called DAILIES® Total1®
Investigational, silicone hydrogel, single vision, soft contact lens for daily disposable wear
Etafilcon A contact lensDevice
Also called 1-DAY ACUVUE® MOIST™
Commercially marketed, HEMA-based, single vision, soft contact lens for daily disposable wear

Study groups in NCT01362907
Study group	Role	What they receive
Delefilcon A / etafilcon A	Other	Delefilcon A contact lenses worn first, with etafilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each. Receives: Device: Delefilcon A contact lens; Device: Etafilcon A contact lens
Etafilcon A / delefilcon A	Other	Etafilcon A contact lenses worn first, with delefilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each. Receives: Device: Delefilcon A contact lens; Device: Etafilcon A contact lens

What is being measured

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

Corrected Distance Monocular Visual Measurement Reported as Visual Acuity (VA)
As tested for each eye individually while wearing study lenses. VA was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. Positive logMAR values indicated poorer vision, and negative values denoted better visual acuity.
Measured: 1 week of wear, replacing lenses daily
Overall Comfort
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Measured: 1 week of wear, replacing lenses daily
Overall Vision Quality
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision quality was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Measured: 1 week of wear, replacing lenses daily
Overall Handling
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being difficult and 10 being easy.
Measured: 1 week of wear, replacing lenses daily

Secondary outcomes (1)

Overall Lens Fit
As assessed for each eye individually by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit is reported on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight.
Measured: 1 week of wear, replacing lenses daily

Timeline

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

May 2011Jun 2011

First posted1 Jun 2011 (estimated)
Study startMay 2011
Primary completionJun 2011
Study completionJun 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: Crossover
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01362907
Sponsor's protocol ID: P-347-C-013
Status last verified: Jun 2012
First submitted: 27 May 2011
Last updated: 3 Aug 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

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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Comparison of Silicone Hydrogel and HEMA-based Daily Disposable Contact Lenses
ClinicalTrials.gov ID: NCT01362907
Acronym / sponsor ID: P-347-C-013
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: CIBA VISIONIndustry (pharma, biotech, devices)
Study start: May 2011
Primary completion: Jun 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 1 Jun 2011 (estimated)
Results: Posted 3 Aug 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 trial was to compare the performance of an investigational daily disposable contact lens to a commercially available daily disposable contact lens.

Study design

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

Arm	Type	Receives
Delefilcon A / etafilcon A	Other	Device: Delefilcon A contact lens, Device: Etafilcon A contact lensDelefilcon A contact lenses worn first, with etafilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
Etafilcon A / delefilcon A	Other	Device: Delefilcon A contact lens, Device: Etafilcon A contact lensEtafilcon A contact lenses worn first, with delefilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.

Who may qualify

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

Key inclusion criteria (7 listed)

Normal eyes with no use of 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 protocol-specified timeframe within the available range of powers (-1.00 D to -6.00D in 0.25D steps).
Visual acuity with study lenses 20/25 or better.
Cylinder less than or equal to 0.75 D.

Key exclusion criteria (7 listed)

Anterior segment infection, inflammation, or abnormality.
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.
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 lensAlso: DAILIES® Total1®Investigational, silicone hydrogel, single vision, soft contact lens for daily disposable wear	Device	Delefilcon A / etafilcon A, Etafilcon A / delefilcon A
Etafilcon A contact lensAlso: 1-DAY ACUVUE® MOIST™Commercially marketed, HEMA-based, single vision, soft contact lens for daily disposable wear	Device	Delefilcon A / etafilcon A, Etafilcon A / delefilcon A

Primary outcome

Corrected Distance Monocular Visual Measurement Reported as Visual Acuity (VA)
Time frame: 1 week of wear, replacing lenses daily
As tested for each eye individually while wearing study lenses. VA was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. Positive logMAR values indicated poorer vision, and negative values denoted better visual acuity.
Overall Comfort
Time frame: 1 week of wear, replacing lenses daily
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Overall Vision Quality
Time frame: 1 week of wear, replacing lenses daily
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision quality was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Overall Handling
Time frame: 1 week of wear, replacing lenses daily
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being difficult and 10 being easy.

1 secondary outcome

Overall Lens Fit
Time frame: 1 week of wear, replacing lenses daily

Results and safety

Results posted to the registry on 3 Aug 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 / Etafilcon A	20	20
Etafilcon A / Delefilcon A	20	20

Primary outcome: Corrected Distance Monocular Visual Measurement Reported as Visual Acuity (VA)

Time frame: 1 week of wear, replacing lenses daily. Mean (Standard Deviation). Unit: logMAR

Measure	Delefilcon A n = 40	Etafilcon A n = 40
Value	-0.02 (0.06)	-0.02 (0.05)

Population analysed: All enrolled and dispensed participants.

Primary outcome: Overall Comfort

Time frame: 1 week of wear, replacing lenses daily. Mean (Standard Deviation). Unit: Units on a scale

Measure	Delefilcon A n = 40	Etafilcon A n = 40
Value	9.0 (1.5)	8.1 (1.6)

Population analysed: All enrolled and dispensed participants.

Primary outcome: Overall Vision Quality

Time frame: 1 week of wear, replacing lenses daily. Mean (Standard Deviation). Unit: Units on a scale

Measure	Delefilcon A n = 40	Etafilcon A n = 40
Value	9.4 (1.0)	8.9 (1.2)

Population analysed: All enrolled and dispensed participants.

Primary outcome: Overall Handling

Time frame: 1 week of wear, replacing lenses daily. Mean (Standard Deviation). Unit: Units on a scale

Measure	Delefilcon A n = 40	Etafilcon A n = 40
Value	8.5 (1.9)	8.6 (1.4)

Population analysed: All enrolled and dispensed participants.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected for the duration of the trial: 1 month.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Delefilcon A	0 of 40 (0%)	0 of 40 (0%)	Not reported
Etafilcon A	0 of 40 (0%)	0 of 40 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 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 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 7 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 3 Aug 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 3 Aug 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 Reported as Visual Acuity (VA) (time frame: 1 week of wear, replacing lenses daily). The study lists 4 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 NCT01362907.

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 3 Aug 2012.