Refractive ErrorNCT02103309

Comparative Evaluation of Contact Lens Centering of DAILIES® AquaComfort Plus® Versus 1-DAY ACUVUE® MOIST® in Japan

A study testing Nelfilcon A contact lenses and Etafilcon A contact lenses in people with Refractive Error and Myopia, run by Alcon Research.

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 lens centration and subjective impressions of DAILIES® AquaComfort Plus® (DACP) lenses compared to 1-DAY ACUVUE® MOIST® (1DAM) lenses in ball sports players. Read more about this study

Who is it for?: Ages 18 to 29 years
Conditions the study is for: Refractive Error, Myopia, Myopic Astigmatism
What is being tested?: Nelfilcon A contact lenses and Etafilcon A contact lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: No sites listed yet
Study dates: Oct 2013to Nov 2013
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 18 to 29 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Those who can understand the clinical study objectives and provide written informed consent. Legal representative or parental consent required if under age 20
Those who regularly wear soft contact lenses in both eyes for a minimum of 8 hours per day and 5 days per week
Those who play ball sports at least 1 day per week
Those who need vision correction because of myopia or mild myopic astigmatism, who are eligible for use of the study device, and who can attain a visual acuity of at least 1.0 with correction
Other protocol-defined inclusion criteria may apply

Who cannot join

Those who regularly wear the study device
Those who require ocular treatment with eye drops
Those who have a condition contraindicating soft contact lens wear, such as eye irritation
Those who have had ocular disorder or ocular surgery that may affect soft contact lens wear within 3 months before the start of the study
Those who are participating in another clinical study or research or have a plan of such participation during the present study
Women who are pregnant or intend to become pregnant during the study
Other protocol-defined exclusion criteria may apply

About this study

Official title: Comparative Evaluation of Contact Lens Centering of DAILIES® AquaComfort Plus® Versus 1-DAY ACUVUE® MOIST®

Conditions: Refractive Error, Myopia, Myopic Astigmatism
Being tested: Nelfilcon A contact lenses, Etafilcon A contact lenses
Keywords: Soft contact lenses, DACP
Medical subject headings: Refractive Errors, Myopia, Astigmatism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nelfilcon A contact lensesDevice
Also called DAILIES® AquaComfort® Plus, DACP
Etafilcon A contact lensesDevice
Also called 1-DAY ACUVUE® MOIST®

Study groups in NCT02103309
Study group	Role	What they receive
DACP, then 1DAM	Other	Nelfilcon A contact lenses worn first, then etafilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode. Receives: Device: Nelfilcon A contact lenses; Device: Etafilcon A contact lenses
1DAM, then DACP	Other	Etafilcon A contact lenses worn first, then nelfilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode. Receives: Device: Nelfilcon A contact lenses; Device: Etafilcon A contact lenses

What is being measured

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

Mean Investigator-Rated Lens Centration
Lens centration was assessed by the investigator using slit-lamp microscopy and rated on a 5-point scale, where 0=Optimal and 4=Severe decentration. Both eyes contributed to the mean.
Measured: After 1 week of wear

Secondary outcomes (3)

Mean Investigator-Rated Lens Fit
Lens fit was assessed by the investigator and rated on a 5-point scale with -2=Unacceptable tight fit, -1=Acceptable tight fit, 0=Optimal, 1=Acceptable loose fit, and 2=Uacceptable loose fit. Both eyes contributed to the mean.
Measured: After 1 week of wear
Average Subjective Ratings Score (Lens Handling and Overall Vision)
The participant rated the handling and overall vision of the contact lenses on a 10-point scale, where 10=Excellent and 1=Poor. Both eyes contributed to the mean.
Measured: After 1 week of wear
Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports)
The participant rated the lens wearing conditions and visual performance of the contact lenses during ball sports on a 10-point scale, where 10=Agree and 1=Disagree. "Overall Vision" was rated with 10=Excellent and 1=Poor. Both eyes contributed to the mean.
Measured: After 1 week of wear

Timeline

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

Oct 2013Nov 2013

First posted3 Apr 2014 (estimated)
Study startOct 2013
Primary completionNov 2013
Study completionNov 2013

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 Refractive ErrorStudies of the same condition, open and under way.
More trials run by Alcon ResearchThe sponsor's other registered studies.
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: Single blind
Who is masked: Participant
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02103309
Sponsor's protocol ID: M-13-050
Status last verified: Oct 2014
First submitted: 1 Apr 2014
Last updated: 29 Oct 2014
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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All Refractive Error trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Evaluation of Contact Lens Centering of DAILIES® AquaComfort Plus® Versus 1-DAY ACUVUE® MOIST®
ClinicalTrials.gov ID: NCT02103309
Acronym / sponsor ID: M-13-050
Conditions: Refractive Error, Myopia, Myopic Astigmatism
Keywords: Soft contact lenses, DACP
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Oct 2013
Primary completion: Nov 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 3 Apr 2014 (estimated)
Results: Posted 29 Oct 2014

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: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
DACP, then 1DAM	Other	Device: Nelfilcon A contact lenses, Device: Etafilcon A contact lensesNelfilcon A contact lenses worn first, then etafilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
1DAM, then DACP	Other	Device: Nelfilcon A contact lenses, Device: Etafilcon A contact lensesEtafilcon A contact lenses worn first, then nelfilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode.

Who may qualify

Ages: 18 to 29 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Those who can understand the clinical study objectives and provide written informed consent. Legal representative or parental consent required if under age 20
Those who regularly wear soft contact lenses in both eyes for a minimum of 8 hours per day and 5 days per week
Those who play ball sports at least 1 day per week
Those who need vision correction because of myopia or mild myopic astigmatism, who are eligible for use of the study device, and who can attain a visual acuity of at least 1.0 with correction
Other protocol-defined inclusion criteria may apply

Key exclusion criteria (7 listed)

Those who regularly wear the study device
Those who require ocular treatment with eye drops
Those who have a condition contraindicating soft contact lens wear, such as eye irritation
Those who have had ocular disorder or ocular surgery that may affect soft contact lens wear within 3 months before the start of the study
Those who are participating in another clinical study or research or have a plan of such participation during the present study

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 lensesAlso: DAILIES® AquaComfort® Plus, DACP	Device	1DAM, then DACP, DACP, then 1DAM
Etafilcon A contact lensesAlso: 1-DAY ACUVUE® MOIST®	Device	1DAM, then DACP, DACP, then 1DAM

Primary outcome

Mean Investigator-Rated Lens Centration
Time frame: After 1 week of wear
Lens centration was assessed by the investigator using slit-lamp microscopy and rated on a 5-point scale, where 0=Optimal and 4=Severe decentration. Both eyes contributed to the mean.

3 secondary outcomes

Mean Investigator-Rated Lens Fit
Time frame: After 1 week of wear
Average Subjective Ratings Score (Lens Handling and Overall Vision)
Time frame: After 1 week of wear
Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports)
Time frame: After 1 week of wear

Results and safety

Results posted to the registry on 29 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DACP, Then 1DAM	20	20
1DAM, Then DACP	22	22

Primary outcome: Mean Investigator-Rated Lens Centration

Time frame: After 1 week of wear. Mean (Standard Deviation). Unit: units on a scale

Measure	DACP n = 41	1DAM n = 39
Value	0.34 (0.47)	0.73 (0.83)

Population analysed: This analysis population includes all enrolled participants minus missing data.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected for the duration of the study (1 month). This analysis group includes (Safety Population). based on treatment-specific exposure. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DACP	0 of 42 (0%)	0 of 42 (0%)	Not reported
1DAM	0 of 42 (0%)	0 of 42 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Refractive Error

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
RecruitingPhase 1/2
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
Amblyopia
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.

Lisa L. Zoota, MPH, CCRA study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A study testing Nelfilcon A contact lenses and Etafilcon A contact lenses in people with Refractive Error and Myopia, run by Alcon Research.

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 5 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 29 Oct 2014. 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 29 Oct 2014). 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?

Mean Investigator-Rated Lens Centration (time frame: After 1 week of wear). 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 NCT02103309.

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 29 Oct 2014.