MyopiaNCT01254747

Clinical Evaluation of an Investigational Soft Contact Lens

A study testing Delefilcon A contact lens, Lotrafilcon B contact lens (O2 OPTIX, AIR OPTIX) and Nelfilcon A contact lens (DAILIES AquaComfort Plus) in people with Myopia, run by CIBA VISION at 2 sites in 2 countries.

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 4-week dispensing trial is to evaluate and compare an investigational soft contact lens worn on a daily disposable basis with three other soft contact lenses also worn on a daily disposable basis. 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, Lotrafilcon B contact lens (O2 OPTIX, AIR OPTIX) and Nelfilcon A contact lens (DAILIES AquaComfort Plus)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 130 participants
Where: 2 sitesin 2 countries
Study dates: Nov 2010to Dec 2010
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

Germany: Be of legal age.
USA: Be of legal age or, if under legal age, have written consent of parent/guardian to participate and sign informed assent.
Sign Informed Consent.
Wear soft contact lenses for at least 3 months prior to the study.
Wear soft contact lenses on a daily disposable basis, daily wear basis, or occasional extended wear basis.
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.
Currently enrolled in any clinical trial.
Regularly wear contact lenses on an extended/overnight basis.
Germany: pregnant or lactating.
Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

United States1 site

CIBA VISION Research Clinic
Duluth, Georgia, 30097

Other trials in United States

Germany1 site

CIBA VISION Research Clinic
Großwallstadt, 63868

Other trials in Germany

About this study

Conditions: Myopia
Being tested: Delefilcon A contact lens, Lotrafilcon B contact lens (O2 OPTIX, AIR OPTIX), Nelfilcon A contact lens (DAILIES AquaComfort Plus), Narafilcon A contact lens (1-DAY ACUVUE TRUEYE)
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 contact lens for daily wear, daily disposable use
Lotrafilcon B contact lens (O2 OPTIX, AIR OPTIX)Device
Also called O2 OPTIX®, AIR OPTIX®
Commercially marketed silicone hydrogel, single vision contact lens for daily wear, daily disposable use
Nelfilcon A contact lens (DAILIES AquaComfort Plus)Device
Also called DAILIES® AquaComfort Plus®
Commercially marketed hydrogel, single vision contact lens for daily wear, daily disposable use
Narafilcon A contact lens (1-DAY ACUVUE TRUEYE)Device
Also called 1-DAY ACUVUE® TRUEYE™
Commercially marketed (Europe) silicone hydrogel, single vision contact lens for daily wear, daily disposable use

Study groups in NCT01254747
Study group	Role	What they receive
Delefilcon A	Experimental	Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks. Receives: Device: Delefilcon A contact lens
Lotrafilcon B	Active comparator	Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks. Receives: Device: Lotrafilcon B contact lens (O2 OPTIX, AIR OPTIX)
Nelfilcon A	Active comparator	Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks. Receives: Device: Nelfilcon A contact lens (DAILIES AquaComfort Plus)
Narafilcon A	Active comparator	Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks. Receives: Device: Narafilcon A contact lens (1-DAY ACUVUE TRUEYE)

What is being measured

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

Overall Comfort
Overall comfort was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Measured: 4 weeks
Vision Quality During the Day
Vision quality during the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Vision quality during the day was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Measured: 4 weeks
Overall Handling
Overall handling was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall handling was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Measured: 4 weeks
Dryness Throughout the Day
Dryness throughout the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Dryness throughout the day was measured on a 10-point scale, with 1 being very dry and 10 being not dry.
Measured: 4 weeks
Average Daily Wear Time
Average daily wear time (hours) was reported by the participant as a single, retrospective evaluation of 4 weeks of wear.
Measured: 4 weeks

Secondary outcomes (3)

Lens Fit
Lens fit was assessed by the investigator for each eye using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptable loose, 1=acceptable loose, 0=optimal, -1=acceptable tight, and -2=unacceptable tight.
Measured: 4 weeks
Corrected Visual Acuity
Corrected visual acuity was tested for each eye while the participant read distant charts in normal lighting. Corrected visual acuity was measured with a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.
Measured: 4 weeks
Overall Satisfaction
Overall satisfaction was recorded on a 5-point Likert scale as a single, retrospective evaluation of 4 weeks of wear. The following scale was used: 2=very satisfied, 1=somewhat satisfied, 0=neither, -1=somewhat dissatisfied, and -2=very dissatisfied.
Measured: 4 weeks

Timeline

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

Nov 2010Dec 2010

First posted7 Dec 2010 (estimated)
Study startNov 2010
Primary completionDec 2010
Study completionDec 2010

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: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01254747
Sponsor's protocol ID: P-347-C-003v2s2v2
Status last verified: Apr 2012
First submitted: 3 Dec 2010
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 an Investigational Soft Contact Lens
ClinicalTrials.gov ID: NCT01254747
Acronym / sponsor ID: P-347-C-003v2s2v2
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: CIBA VISIONIndustry (pharma, biotech, devices)
Study start: Nov 2010
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 7 Dec 2010 (estimated)
Results: Posted 17 May 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
Delefilcon A	Experimental	Device: Delefilcon A contact lensDelefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Lotrafilcon B	Active comparator	Device: Lotrafilcon B contact lens (O2 OPTIX, AIR OPTIX)Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Nelfilcon A	Active comparator	Device: Nelfilcon A contact lens (DAILIES AquaComfort Plus)Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Narafilcon A	Active comparator	Device: Narafilcon A contact lens (1-DAY ACUVUE TRUEYE)Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.

Who may qualify

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

Key inclusion criteria (6 listed)

Germany: Be of legal age.
USA: Be of legal age or, if under legal age, have written consent of parent/guardian to participate and sign informed assent.
Sign Informed Consent.
Wear soft contact lenses for at least 3 months prior to the study.
Wear soft contact lenses on a daily disposable basis, daily wear basis, or occasional extended wear basis.

Key exclusion criteria (6 listed)

Eye injury or surgery within twelve weeks prior to enrollment.
Pre-existing ocular irritation that would preclude contact lens fitting.
Currently enrolled in any clinical trial.
Regularly wear contact lenses on an extended/overnight basis.
Germany: pregnant or lactating.

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 contact lens for daily wear, daily disposable use	Device	Delefilcon A
Lotrafilcon B contact lens (O2 OPTIX, AIR OPTIX)Also: O2 OPTIX®, AIR OPTIX®Commercially marketed silicone hydrogel, single vision contact lens for daily wear, daily disposable use	Device	Lotrafilcon B
Nelfilcon A contact lens (DAILIES AquaComfort Plus)Also: DAILIES® AquaComfort Plus®Commercially marketed hydrogel, single vision contact lens for daily wear, daily disposable use	Device	Nelfilcon A
Narafilcon A contact lens (1-DAY ACUVUE TRUEYE)Also: 1-DAY ACUVUE® TRUEYE™Commercially marketed (Europe) silicone hydrogel, single vision contact lens for daily wear, daily disposable use	Device	Narafilcon A

Primary outcome

Overall Comfort
Time frame: 4 weeks
Overall comfort was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Vision Quality During the Day
Time frame: 4 weeks
Vision quality during the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Vision quality during the day was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Overall Handling
Time frame: 4 weeks
Overall handling was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall handling was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Dryness Throughout the Day
Time frame: 4 weeks
Dryness throughout the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Dryness throughout the day was measured on a 10-point scale, with 1 being very dry and 10 being not dry.
Average Daily Wear Time
Time frame: 4 weeks
Average daily wear time (hours) was reported by the participant as a single, retrospective evaluation of 4 weeks of wear.

3 secondary outcomes

Lens Fit
Time frame: 4 weeks
Corrected Visual Acuity
Time frame: 4 weeks
Overall Satisfaction
Time frame: 4 weeks

Results and safety

Results posted to the registry on 17 May 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	40	40
Lotrafilcon B	29	23
Nelfilcon A	30	26
Narafilcon A	30	28

Primary outcome: Overall Comfort

Time frame: 4 weeks. Mean (Standard Deviation). Unit: Units on a scale

Measure	Delefilcon A n = 40	Lotrafilcon B n = 23	Nelfilcon A n = 26	Narafilcon A n = 28
Value	9.5 (0.7)	7.9 (1.6)	9.0 (0.9)	8.6 (1.2)

Population analysed: Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Primary outcome: Vision Quality During the Day

Time frame: 4 weeks. Mean (Standard Deviation). Unit: Units on a scale

Measure	Delefilcon A n = 40	Lotrafilcon B n = 23	Nelfilcon A n = 26	Narafilcon A n = 28
Value	9.6 (0.6)	8.8 (1.2)	9.5 (0.9)	8.7 (1.3)

Population analysed: Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Primary outcome: Overall Handling

Time frame: 4 weeks. Mean (Standard Deviation). Unit: Units on a scale

Measure	Delefilcon A n = 40	Lotrafilcon B n = 23	Nelfilcon A n = 26	Narafilcon A n = 28
Value	9.3 (0.9)	8.5 (1.4)	9.3 (0.9)	9.1 (1.3)

Population analysed: Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Primary outcome: Dryness Throughout the Day

Time frame: 4 weeks. Mean (Standard Deviation). Unit: Units on a scale

Measure	Delefilcon A n = 40	Lotrafilcon B n = 23	Nelfilcon A n = 26	Narafilcon A n = 28
Value	9.5 (0.6)	7.7 (2.0)	9.0 (1.5)	8.5 (1.5)

Population analysed: Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected for the duration of the trial: 15-NOV-2010 to 20-DEC-2010.. 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
Lotrafilcon B	0 of 29 (0%)	5 of 29 (17.2%)	Not reported
Nelfilcon A	0 of 30 (0%)	2 of 30 (6.7%)	Not reported
Narafilcon A	0 of 30 (0%)	2 of 30 (6.7%)	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.

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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.

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 6 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 2 sites in United States, Germany. 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 17 May 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?

Overall Comfort (time frame: 4 weeks). The study lists 5 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 NCT01254747.

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.