MyopiaARGONNCT01155726

The Effect of Masking on Subjective Results During Daily Disposable Contact Lens Studies

A study testing Nelfilcon A contact lens, Nelfilcon A contact lens with comfort additive (DACP), unmasked and Nelfilcon A contact lens with comfort additive (DACP), masked in people with Myopia and Hyperopia, run by CIBA VISION at 1 site in Canada.

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 explore the effect of masking on subjective ratings for two daily disposable contact lenses. Read more about this study

Who is it for?: Ages 17 years and older
Conditions the study is for: Myopia, Hyperopia
What is being tested?: Nelfilcon A contact lens, Nelfilcon A contact lens with comfort additive (DACP), unmasked and Nelfilcon A contact lens with comfort additive (DACP), masked
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 134 participants
Where: 1 siteCanada
Study dates: May 2010to Feb 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 17 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

17 years of age or older.
Ocular exam within 2 years.
Currently wearing soft contact lenses on a daily wear basis.
Contact lens prescription between +6.00D and -10.00D.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Any ocular disease.
Use of systemic or ocular medications that may affect ocular health.
Unable to achieve an acceptable fit with the study lenses.
Anisometropia >1.00D or astigmatism >0.75D.
Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Centre for Contact Lens Research: University of Waterloo
Waterloo, Ontario, N2L 3G1

Other trials in Canada

About this study

The purpose of this study is to explore the effect of masking on subjective ratings for two daily disposable contact lenses.

Conditions: Myopia, Hyperopia
Being tested: Nelfilcon A contact lens, Nelfilcon A contact lens with comfort additive (DACP), unmasked, Nelfilcon A contact lens with comfort additive (DACP), masked, Nelfilcon A contact lens with comfort additive (DACP), partially masked, Etafilcon A contact lens
Medical subject headings: Myopia, Hyperopia

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 Focus DAILIES®
Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and lens packaging visible to participant. Lenses inserted and removed by participant.
Nelfilcon A contact lens with comfort additive (DACP), unmaskedDevice
Also called DAILIES® AquaComfort Plus®
Commercially marketed, soft, hydrogel contact lens with comfort additive for daily wear, daily disposable use. Blister pack label and lens packaging visible to participant. Lenses and removed inserted by participant.
Nelfilcon A contact lens with comfort additive (DACP), maskedDevice
Also called DAILIES® AquaComfort Plus®
Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and packaging not visible to participant. Lenses inserted and removed by the investigator.
Nelfilcon A contact lens with comfort additive (DACP), partially maskedDevice
Also called DAILIES® AquaComfort Plus®
Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Lens name and manufacturer on blister pack label concealed from participant. Lenses inserted and removed by the participant.
Etafilcon A contact lensDevice
Also called 1-DAY ACUVUE®
Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and lens packaging visible to participant. Lenses inserted and removed by participant.
Etafilcon A contact lens with comfort additive (1DAVM), unmaskedDevice
Also called 1-DAY ACUVUE® MOIST®
Commercially marketed, soft, hydrogel contact lens with comfort additive for daily wear, daily disposable use. Blister pack label and lens packaging visible to participant. Lenses inserted and removed by participant.
Etafilcon A contact lens with comfort additive (1DAVM), maskedDevice
Also called 1-DAY ACUVUE® MOIST®
Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and packaging not visible to participant. Lenses inserted and removed by the investigator.
Etafilcon A contact lens with comfort additive (1DAVM), partially maskedDevice
Also called 1-DAY ACUVUE® MOIST®
Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Lens name and manufacturer on blister pack label concealed from participant. Lenses inserted and removed by the participant.

Study groups in NCT01155726
Study group	Role	What they receive
Nelfilcon A, Masked, Unmasked	Active comparator	Nelfilcon A worn in adaptation phase (bilaterally, 30 days). Period 1: 1DAVM and DACP (masked) worn contralaterally in random assignment for 3 days. Period 2: 1DAVM and DACP (unmasked) worn contralaterally, same assignment, 3 days. All products worn in a daily wear, daily disposable mode. Receives: Device: Nelfilcon A contact lens; Device: Nelfilcon A contact lens with comfort additive (DACP), unmasked; Device: Nelfilcon A contact lens with comfort additive (DACP), masked; Device: Etafilcon A contact lens with comfort additive (1DAVM), unmasked; Device: Etafilcon A contact lens with comfort additive (1DAVM), masked
Nelfilcon A, Masked, Partially Masked	Active comparator	Nelfilcon A worn in adaptation phase (bilaterally, 30 days). Period 1: 1DAVM and DACP (masked) worn contralaterally in random assignment for 3 days. Period 2: 1DAVM and DACP (partially masked) worn contralaterally, same assignment, 3 days. All products worn in a daily wear, daily disposable mode. Receives: Device: Nelfilcon A contact lens; Device: Nelfilcon A contact lens with comfort additive (DACP), masked; Device: Nelfilcon A contact lens with comfort additive (DACP), partially masked; Device: Etafilcon A contact lens with comfort additive (1DAVM), masked; Device: Etafilcon A contact lens with comfort additive (1DAVM), partially masked
Etafilcon A, Masked, Unmasked	Active comparator	Etafilcon A worn in adaptation phase (bilaterally, 30 days). Period 1: 1DAVM and DACP (masked) worn contralaterally in random assignment for 3 days. Period 2: 1DAVM and DACP (unmasked) worn contralaterally, same assignment, 3 days. All products worn in a daily wear, daily disposable mode. Receives: Device: Nelfilcon A contact lens with comfort additive (DACP), unmasked; Device: Nelfilcon A contact lens with comfort additive (DACP), masked; Device: Etafilcon A contact lens; Device: Etafilcon A contact lens with comfort additive (1DAVM), unmasked; Device: Etafilcon A contact lens with comfort additive (1DAVM), masked
Etafilcon A, Masked, Partially Masked	Active comparator	Etafilcon A worn in adaptation phase (bilaterally, 30 days). Period 1: 1DAVM and DACP (masked) worn contralaterally in random assignment for 3 days. Period 2: 1DAVM and DACP (partially masked) worn contralaterally, same assignment, 3 days. All products worn in a daily wear, daily disposable mode. Receives: Device: Nelfilcon A contact lens with comfort additive (DACP), masked; Device: Nelfilcon A contact lens with comfort additive (DACP), partially masked; Device: Etafilcon A contact lens; Device: Etafilcon A contact lens with comfort additive (1DAVM), masked; Device: Etafilcon A contact lens with comfort additive (1DAVM), partially masked

What is being measured

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

Average Subjective Comfort
Participants were asked, "How would you rate your comfort with your study lenses?" and indicated their response by marking a continuum line ranging from 0=very poor comfort to 100=excellent comfort. Subjective comfort was collected at three time points (insertion, 4 hours, 8 hours) for 3 days, and the comfort ratings were averaged together.
Measured: Insertion, 4 hours, 8 hours each: Day 1, Day 2, and Day 3

Timeline

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

May 2010Feb 2011

First posted2 Jul 2010 (estimated)
Study startMay 2010
Primary completionFeb 2011
Study completionFeb 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: 134 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01155726
Sponsor's protocol ID: P-371-C-101
Acronym: ARGON
Status last verified: Apr 2012
First submitted: 30 Jun 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: The Effect of Masking on Subjective Results During Daily Disposable Contact Lens Studies
ClinicalTrials.gov ID: NCT01155726
Acronym / sponsor ID: ARGON / P-371-C-101
Conditions: Myopia, Hyperopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 134 participants (actual)
Lead sponsor: CIBA VISIONIndustry (pharma, biotech, devices)
Study start: May 2010
Primary completion: Feb 2011 (actual)
Study completion: Feb 2011 (actual)
First posted: 2 Jul 2010 (estimated)
Results: Posted 15 May 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 explore the effect of masking on subjective ratings for two daily disposable contact lenses.

Study design

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

Arm	Type	Receives
Nelfilcon A, Masked, Unmasked	Active comparator	Device: Nelfilcon A contact lens, Device: Nelfilcon A contact lens with comfort additive (DACP), unmasked, Device: Nelfilcon A contact lens with comfort additive (DACP), masked, Device: Etafilcon A contact lens with comfort additive (1DAVM), unmasked, Device: Etafilcon A contact lens with comfort additive (1DAVM), maskedNelfilcon A worn in adaptation phase (bilaterally, 30 days). Period 1: 1DAVM and DACP (masked) worn contralaterally in random assignment for 3 days. Period 2: 1DAVM and DACP (unmasked) worn contralaterally, same assignment, 3 days. All products worn in a daily wear, daily disposable mode.
Nelfilcon A, Masked, Partially Masked	Active comparator	Device: Nelfilcon A contact lens, Device: Nelfilcon A contact lens with comfort additive (DACP), masked, Device: Nelfilcon A contact lens with comfort additive (DACP), partially masked, Device: Etafilcon A contact lens with comfort additive (1DAVM), masked, Device: Etafilcon A contact lens with comfort additive (1DAVM), partially maskedNelfilcon A worn in adaptation phase (bilaterally, 30 days). Period 1: 1DAVM and DACP (masked) worn contralaterally in random assignment for 3 days. Period 2: 1DAVM and DACP (partially masked) worn contralaterally, same assignment, 3 days. All products worn in a daily wear, daily disposable mode.
Etafilcon A, Masked, Unmasked	Active comparator	Device: Nelfilcon A contact lens with comfort additive (DACP), unmasked, Device: Nelfilcon A contact lens with comfort additive (DACP), masked, Device: Etafilcon A contact lens, Device: Etafilcon A contact lens with comfort additive (1DAVM), unmasked, Device: Etafilcon A contact lens with comfort additive (1DAVM), maskedEtafilcon A worn in adaptation phase (bilaterally, 30 days). Period 1: 1DAVM and DACP (masked) worn contralaterally in random assignment for 3 days. Period 2: 1DAVM and DACP (unmasked) worn contralaterally, same assignment, 3 days. All products worn in a daily wear, daily disposable mode.
Etafilcon A, Masked, Partially Masked	Active comparator	Device: Nelfilcon A contact lens with comfort additive (DACP), masked, Device: Nelfilcon A contact lens with comfort additive (DACP), partially masked, Device: Etafilcon A contact lens, Device: Etafilcon A contact lens with comfort additive (1DAVM), masked, Device: Etafilcon A contact lens with comfort additive (1DAVM), partially maskedEtafilcon A worn in adaptation phase (bilaterally, 30 days). Period 1: 1DAVM and DACP (masked) worn contralaterally in random assignment for 3 days. Period 2: 1DAVM and DACP (partially masked) worn contralaterally, same assignment, 3 days. All products worn in a daily wear, daily disposable mode.

Who may qualify

Ages: 17 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

17 years of age or older.
Ocular exam within 2 years.
Currently wearing soft contact lenses on a daily wear basis.
Contact lens prescription between +6.00D and -10.00D.
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (5 listed)

Any ocular disease.
Use of systemic or ocular medications that may affect ocular health.
Unable to achieve an acceptable fit with the study lenses.
Anisometropia >1.00D or astigmatism >0.75D.
Other protocol-defined exclusion criteria may apply.

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: Focus DAILIES®Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and lens packaging visible to participant. Lenses inserted and removed by participant.	Device	Nelfilcon A, Masked, Partially Masked, Nelfilcon A, Masked, Unmasked
Nelfilcon A contact lens with comfort additive (DACP), unmaskedAlso: DAILIES® AquaComfort Plus®Commercially marketed, soft, hydrogel contact lens with comfort additive for daily wear, daily disposable use. Blister pack label and lens packaging visible to participant. Lenses and removed inserted by participant.	Device	Etafilcon A, Masked, Unmasked, Nelfilcon A, Masked, Unmasked
Nelfilcon A contact lens with comfort additive (DACP), maskedAlso: DAILIES® AquaComfort Plus®Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and packaging not visible to participant. Lenses inserted and removed by the investigator.	Device	Etafilcon A, Masked, Partially Masked, Etafilcon A, Masked, Unmasked, Nelfilcon A, Masked, Partially Masked, Nelfilcon A, Masked, Unmasked
Nelfilcon A contact lens with comfort additive (DACP), partially maskedAlso: DAILIES® AquaComfort Plus®Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Lens name and manufacturer on blister pack label concealed from participant. Lenses inserted and removed by the participant.	Device	Etafilcon A, Masked, Partially Masked, Nelfilcon A, Masked, Partially Masked
Etafilcon A contact lensAlso: 1-DAY ACUVUE®Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and lens packaging visible to participant. Lenses inserted and removed by participant.	Device	Etafilcon A, Masked, Partially Masked, Etafilcon A, Masked, Unmasked
Etafilcon A contact lens with comfort additive (1DAVM), unmaskedAlso: 1-DAY ACUVUE® MOIST®Commercially marketed, soft, hydrogel contact lens with comfort additive for daily wear, daily disposable use. Blister pack label and lens packaging visible to participant. Lenses inserted and removed by participant.	Device	Etafilcon A, Masked, Unmasked, Nelfilcon A, Masked, Unmasked
Etafilcon A contact lens with comfort additive (1DAVM), maskedAlso: 1-DAY ACUVUE® MOIST®Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and packaging not visible to participant. Lenses inserted and removed by the investigator.	Device	Etafilcon A, Masked, Partially Masked, Etafilcon A, Masked, Unmasked, Nelfilcon A, Masked, Partially Masked, Nelfilcon A, Masked, Unmasked
Etafilcon A contact lens with comfort additive (1DAVM), partially maskedAlso: 1-DAY ACUVUE® MOIST®Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Lens name and manufacturer on blister pack label concealed from participant. Lenses inserted and removed by the participant.	Device	Etafilcon A, Masked, Partially Masked, Nelfilcon A, Masked, Partially Masked

Primary outcome

Average Subjective Comfort
Time frame: Insertion, 4 hours, 8 hours each: Day 1, Day 2, and Day 3
Participants were asked, "How would you rate your comfort with your study lenses?" and indicated their response by marking a continuum line ranging from 0=very poor comfort to 100=excellent comfort. Subjective comfort was collected at three time points (insertion, 4 hours, 8 hours) for 3 days, and the comfort ratings were averaged together.

Results and safety

Results posted to the registry on 15 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
Nelfilcon A, Masked, Unmasked	24	23
Nelfilcon A, Masked, Partially Masked	20	20
Etafilcon A, Masked, Unmasked	30	28
Etafilcon A, Masked, Partially Masked	25	25

Primary outcome: Average Subjective Comfort

Time frame: Insertion, 4 hours, 8 hours each: Day 1, Day 2, and Day 3. Mean (Standard Deviation). Unit: Units on a scale

Measure	Nelfilcon A, Pd 1 Masked (1DAVM), Pd 2 Unmasked n = 23	Nelfilcon A, Pd 1 Masked (DACP), Pd 2 Unmasked n = 23	Etafilcon A, Pd 1 Masked (1DAVM), Pd 2 Unmasked n = 28	Etafilcon A, Pd 1 Masked (DACP), Pd 2 Unmasked n = 28	Nelfilcon A, Pd 1 Masked, Pd 2 Unmasked (1DAVM) n = 23	Nelfilcon A, Pd 1 Masked, Pd 2 Unmasked (DACP) n = 23	Etafilcon A, Pd 1 Masked, Pd 2 Unmasked (1DAVM) n = 28	Etafilcon A, Pd 1 Masked, Pd 2 Unmasked (DACP) n = 28	Nelfilcon A, Pd 1 Masked (1DAVM), Pd 2 Partial n = 20	Nelfilcon A, Pd 1 Masked (DACP), Pd 2 Partial n = 20	Etafilcon A, Pd 1 Masked (1DAVM), Pd 2 Partial n = 25	Etafilcon A, Pd 1 Masked (DACP), Pd 2 Partial n = 25	Nelfilcon A, Pd 1 Masked, Pd 2 Partial (1DAVM) n = 20	Nelfilcon A, Pd 1 Masked, Pd 2 Partial (DACP) n = 20	Etafilcon A, Pd 1 Masked, Pd 2 Partial (1DAVM) n = 25	Etafilcon A, Pd 1 Masked, Pd 2 Partial (DACP) n = 25
Value	94.1 (5.9)	92.8 (6.5)	94.1 (5.6)	91.8 (6.4)	93.7 (6.0)	93.3 (5.7)	95.2 (5.8)	93.7 (6.6)	93.4 (6.9)	93.4 (7.1)	93.6 (5.1)	92.2 (5.6)	92.3 (7.0)	93.1 (7.0)	93.5 (6.7)	92.6 (5.8)

Nelfilcon A, Pd 1 Masked (1DAVM), Pd 2 Unmasked vs Nelfilcon A, Pd 1 Masked, Pd 2 Unmasked (1DAVM): Mean Difference (Final Values): -0.4 (95% CI -2.2 to 1.4)
Nelfilcon A, Pd 1 Masked (DACP), Pd 2 Unmasked vs Nelfilcon A, Pd 1 Masked, Pd 2 Unmasked (DACP): Mean Difference (Final Values): 0.5 (95% CI -1.5 to 2.5)
Etafilcon A, Pd 1 Masked (1DAVM), Pd 2 Unmasked vs Etafilcon A, Pd 1 Masked, Pd 2 Unmasked (1DAVM): Mean Difference (Final Values): 1.1 (95% CI -0.1 to 2.2)

Population analysed: Per protocol

Adverse events

Time frame: Adverse events were collected for the duration of the study: 03 May 2010 through 01 February 2011.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nelfilcon A	0 of 127 (0%)	0 of 127 (0%)	Not reported
Etafilcon A	0 of 125 (0%)	0 of 125 (0%)	Not reported
1DAVM	0 of 100 (0%)	0 of 100 (0%)	Not reported
DACP	0 of 100 (0%)	0 of 100 (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.

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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.

1 site in 1 country: 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 5 inclusion and 5 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 1 site in Canada. 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 15 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?

Average Subjective Comfort (time frame: Insertion, 4 hours, 8 hours each: Day 1, Day 2, and Day 3). 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 NCT01155726.

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.