MyopiaNCT00600080

A Comparison of Two Daily Disposable Contact Lenses

A study testing etafilcon A and nelfilcon A in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 1 site in United Kingdom.

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

This study seeks to evaluate the clinical performance of a recently improved daily disposable contact lens to an established daily disposable contact lens that contains a wetting agent. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myopia
What is being tested?: etafilcon A and nelfilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited Kingdom
Study dates: Dec 2007to Mar 2008
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

They are of legal age (18 years) and capacity to volunteer.
They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
They are willing and able to follow the protocol.
They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.
They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).
They have successfully worn contact lenses within six months of starting the study. -

Who cannot join

They have an ocular disorder which would normally contra-indicate contact lens wear.
They have a systemic disorder which would normally contra-indicate contact lens wear.
They are using any topical medication such as eye drops or ointment.
They are aphakic.
They have had corneal refractive surgery.
They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.

Show all 11Show fewer

They are pregnant or lactating.
They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).
They have diabetes.
They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Eurolens Research, The University of Manchester Dpt. of Optometry & Neuroscience
Manchester, M60 1QD

Other trials in United Kingdom

About this study

Official title: The Comparative Clinical Performance of the Etafilcon A Lens and the DAILIES AquaComfort Plus Lens

This study seeks to evaluate the clinical performance of a recently improved daily disposable contact lens to an established daily disposable contact lens that contains a wetting agent.

Conditions: Myopia
Being tested: etafilcon A, nelfilcon A
Medical subject headings: Myopia

What participants receive

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

etafilcon ADevice
Also called 1-DAY ACUVUE MOIST
contact lens worn daily for one week (first or second week depending on arm)
nelfilcon ADevice
Also called DAILIES AquaComfort Plus
Contact lens worn daily for one week (first or second week depending on arm)

Study groups in NCT00600080
Study group	Role	What they receive
etafilcon A first nelfilcon A second	Other	etafilcon A worn daily during week 1, nelfilcon A worn daily for week 2 Receives: Device: etafilcon A; Device: nelfilcon A
nelfilcon A first, etafilcon A second	Other	nelfilcon A worn daily during week 1, etafilcon A worn daily for week 2 Receives: Device: etafilcon A; Device: nelfilcon A

What is being measured

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

Visual Acuity
Measured using high contrast and low contrast vision charts without the use of spectacles (glasses) or refraction equipment (for contact lens wearers). Values are on the logMar scale where lower values (< 0) refer to 'better' values of sight. These scores are converted from a Snellen eye chart examination.
Measured: 2-week
Subjective Lens Comfort
Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= "Extremely poor" or "Cannot use lenses" and 100= "Excellent" or "Highly impressed with these lenses overall"). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used.
Measured: 2-week

Secondary outcomes (2)

Subject-reported Overall Product Performance
Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= "Extremely poor" or "Cannot use lenses" and 100= "Excellent" or "Highly impressed with these lenses overall"). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used.
Measured: 2-week
Optimum Lens Fit
Number of subjects that measured as an optimum fit. Lens fit will be assessed using the following evaluations: horizontal and vertical centration, corneal coverage and movement. Normally, for an acceptable fit, centration and movement will fall within currently accepted clinical criteria [between -1 and +1 on a -2 to +2 grading scale.
Measured: Baseline, 1-week, 2-week

Timeline

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

Dec 2007Mar 2008

First posted24 Jan 2008 (estimated)
Study startDec 2007
Primary completionMar 2008
Study completionMar 2008

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: Single blind
Who is masked: Participant
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00600080
Sponsor's protocol ID: CR-0729
Status last verified: May 2015
First submitted: 21 Dec 2007
Last updated: 21 May 2015
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

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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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
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Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Comparative Clinical Performance of the Etafilcon A Lens and the DAILIES AquaComfort Plus Lens
ClinicalTrials.gov ID: NCT00600080
Acronym / sponsor ID: CR-0729
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Collaborators: University of Manchester
Study start: Dec 2007
Primary completion: Mar 2008 (actual)
Study completion: Mar 2008 (actual)
First posted: 24 Jan 2008 (estimated)
Results: Posted 23 Aug 2012

Clinical summary

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

This study seeks to evaluate the clinical performance of a recently improved daily disposable contact lens to an established daily disposable contact lens that contains a wetting agent.

Study design

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

Arm	Type	Receives
etafilcon A first nelfilcon A second	Other	Device: etafilcon A, Device: nelfilcon Aetafilcon A worn daily during week 1, nelfilcon A worn daily for week 2
nelfilcon A first, etafilcon A second	Other	Device: etafilcon A, Device: nelfilcon Anelfilcon A worn daily during week 1, etafilcon A worn daily for week 2

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

They are of legal age (18 years) and capacity to volunteer.
They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
They are willing and able to follow the protocol.
They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.

Key exclusion criteria (11 listed)

They have an ocular disorder which would normally contra-indicate contact lens wear.
They have a systemic disorder which would normally contra-indicate contact lens wear.
They are using any topical medication such as eye drops or ointment.
They are aphakic.
They have had corneal refractive surgery.

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
etafilcon AAlso: 1-DAY ACUVUE MOISTcontact lens worn daily for one week (first or second week depending on arm)	Device	etafilcon A first nelfilcon A second, nelfilcon A first, etafilcon A second
nelfilcon AAlso: DAILIES AquaComfort PlusContact lens worn daily for one week (first or second week depending on arm)	Device	etafilcon A first nelfilcon A second, nelfilcon A first, etafilcon A second

Primary outcome

Visual Acuity
Time frame: 2-week
Measured using high contrast and low contrast vision charts without the use of spectacles (glasses) or refraction equipment (for contact lens wearers). Values are on the logMar scale where lower values (< 0) refer to 'better' values of sight. These scores are converted from a Snellen eye chart examination.
Subjective Lens Comfort
Time frame: 2-week
Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= "Extremely poor" or "Cannot use lenses" and 100= "Excellent" or "Highly impressed with these lenses overall"). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used.

2 secondary outcomes

Subject-reported Overall Product Performance
Time frame: 2-week
Optimum Lens Fit
Time frame: Baseline, 1-week, 2-week

Results and safety

Results posted to the registry on 23 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
Etafilcon A/Nelfilcon A	28	28
Nelfilcon A/Etafilcon A	32	32

Primary outcome: Visual Acuity

Time frame: 2-week. Mean (Standard Deviation). Unit: logMAR scale

Measure	Nelfilcon A n = 60	Etafilcon A n = 60
High Contrast	-0.10 (0.07)	-0.10 (0.07)
Low Contrast	0.17 (0.09)	0.18 (0.09)

Population analysed: Subjects analyzed are those who were enrolled, randomized to a study arm, and completed the study.

Primary outcome: Subjective Lens Comfort

Time frame: 2-week. Least squares mean (Standard Deviation). Unit: units on a scale

Measure	Nelfilcon A n = 60	Etafilcon A n = 60
Value	86.0 (13.9)	88.2 (12.4)

Population analysed: Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Etafilcon A First Nelfilcon A Second	0 of 60 (0%)	0 of 60 (0%)	Not reported
Nelfilcon A First Etafilcon A Second	0 of 60 (0%)	0 of 60 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing etafilcon A and nelfilcon A in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 1 site in United Kingdom.

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 11 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 21 May 2015. 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 United Kingdom. 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 23 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?

Visual Acuity (time frame: 2-week). The study lists 2 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 NCT00600080.

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 21 May 2015.