MyopiaNCT00727558

A Comparison of Daily Disposable Contact Lenses.

A study testing nelfilcon A and narafilcon A in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 19 sites 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 new CE marked daily disposable contact lens that contains a wetting agent to a recently improved daily disposable contact lens. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Myopia
What is being tested?: nelfilcon A and narafilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 248 participants
Where: 19 sitesUnited Kingdom
Study dates: Jul 2008to Oct 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 to 60 years
All sexes
No healthy volunteers
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

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

United Kingdom19 sites

Leightons Opticians
Albans, Herts, AL1 3LH
Ellis & Killpartrick
Bath, Bath, BA1 1BA
Simon Donne Opticians 3-4
Bedford, Bedfordshire, MK40 1NS
Brock & Houlford
Brislington, Bristol, BS4 3LJ
Keith Tempany Opticians
Broadstone, Dorset, BH18 8DH
Chalmers & Son (Opticians)
Cardiff, South Glamorgan, CF24 3RQ
Susan R Bowers Opticians
Coventry, West Midlands, CV4 9DU
First Contact Opticians
Eastcote Pinner, Middlesex, HA5 1RJ
Bowden & Lowe
Gillingham, Kent, ME7 2YX
Vision Express Optical Lab
Hendon, London, NW4 3FB
Eyecare
Ilford, Essex, IG1 4DU
Hawkes & Wainer
London, London, EC3V 1LT
City Opticians
London, London, WC2A 1AA
Tompkins Knight & Son
Northampton, Northampton, NN2 7BL
The Contact Lens Centre
Plymouth, Devon, PL1 1LB
David Gould Opticians
Rawtenstall, Lancashire, BB4 7QN
Hazel Smith Opticians
Shanklin, Isle of Wight, PO37 6JZ
David H Burns BSC, FCOptom
Tottenham, London, N17 0EY
Viewpoint
York, York, YO1 8BA

Other trials in United Kingdom

About this study

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

Conditions: Myopia
Being tested: nelfilcon A, narafilcon A
Keywords: refractive error
Medical subject headings: Myopia, Refractive Errors

What participants receive

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

nelfilcon ADevice
spherical soft contact lens
narafilcon ADevice
spherical soft contact lens

Study groups in NCT00727558
Study group	Role	What they receive
narafilcon A	Active comparator	spherical soft contact lens worn as a daily disposable modality for one week Receives: Device: narafilcon A
nelfilcon A	Active comparator	spherical soft contact lens worn as a daily disposable modality for one week Receives: Device: nelfilcon A; Device: narafilcon A

What is being measured

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

Overall Comfort
Single question: Comfort scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent
Measured: at 1 week of wear.
Measured Limbal Hyperemia
Measurement of redness of the limbus, graded using half-grade increments using the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.
Measured: at 1 week of wear.

Secondary outcomes (5)

Overall Handling
Rating of overall ease of handling using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent.
Measured: at 1 week of wear
How Comfortable Eyes Feel at the End of the Day
Rating of "How comfortable did your eyes feel at the end of the day when wearing the contact lenses provided" using the following scale: 1=extremely uncomfortable, 2= very uncomfortable, 3=slightly uncomfortable, 4=comfortable, 5=very comfortable.
Measured: at 1 week wear
End of Day Comfort
Rating of comfort at the end of the day using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent
Measured: at 1 week of wear
Initial Comfort
Rating of "comfort immediately when you first put them on" using the following scale: 0=N/A, 1= Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent.
Measured: at 1 week
Inferior Region Corneal Staining
National Eye Institute (NEI) 0-3 scale: grade 0=normal, grade 1=mild, grade 2=moderate, grade 3=severe.
Measured: at 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.

Jul 2008Oct 2008

First posted4 Aug 2008 (estimated)
Study startJul 2008
Primary completionOct 2008
Study completionOct 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: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 248 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00727558
Sponsor's protocol ID: CR-0808
Other IDs: PROD-501
Status last verified: May 2015
First submitted: 30 Jul 2008
Last updated: 21 May 2015
Results posted: Yes, on ClinicalTrials.gov

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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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: A Comparison of Daily Disposable Contact Lenses.
ClinicalTrials.gov ID: NCT00727558
Acronym / sponsor ID: CR-0808
Conditions: Myopia
Keywords: refractive error
Study type: Interventional
Recruitment status: Completed
Enrolment: 248 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Collaborators: Visioncare Research Ltd.
Study start: Jul 2008
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 4 Aug 2008 (estimated)
Results: Posted 18 Feb 2010

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 new CE marked daily disposable contact lens that contains a wetting agent to a recently improved daily disposable contact lens.

Study design

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

Arm	Type	Receives
narafilcon A	Active comparator	Device: narafilcon Aspherical soft contact lens worn as a daily disposable modality for one week
nelfilcon A	Active comparator	Device: nelfilcon A, Device: narafilcon Aspherical soft contact lens worn as a daily disposable modality for one week

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: 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
nelfilcon Aspherical soft contact lens	Device	nelfilcon A
narafilcon Aspherical soft contact lens	Device	narafilcon A, nelfilcon A

Primary outcome

Overall Comfort
Time frame: at 1 week of wear.
Single question: Comfort scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent
Measured Limbal Hyperemia
Time frame: at 1 week of wear.
Measurement of redness of the limbus, graded using half-grade increments using the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.

5 secondary outcomes

Overall Handling
Time frame: at 1 week of wear
How Comfortable Eyes Feel at the End of the Day
Time frame: at 1 week wear
End of Day Comfort
Time frame: at 1 week of wear
Initial Comfort
Time frame: at 1 week
Inferior Region Corneal Staining
Time frame: at 1 week of wear

Results and safety

Results posted to the registry on 18 Feb 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Narafilcon A	127	125
Nelfilcon A	121	118

Primary outcome: Overall Comfort

Time frame: at 1 week of wear.. Least squares mean (Standard Error). Unit: Units on a scale

Measure	Narafilcon A n = 124	Nelfilcon A n = 116
Value	3.903 (0.1446)	3.349 (0.1389)

Narafilcon A vs Nelfilcon A: Mean Difference (Final Values): 0.554 (97.47% CI 0.1721 to 0.554), Mixed Models Analysis

Population analysed: Analysis includes participants who completed the protocol and had no missing data (n=240)

Primary outcome: Measured Limbal Hyperemia

Time frame: at 1 week of wear.. Least squares mean (Standard Error). Unit: Units on a scale

Measure	Narafilcon A n = 125	Nelfilcon A n = 118
Value	0.364 (0.05494)	0.5374 (0.0558)

Narafilcon A vs Nelfilcon A: Mean Difference (Final Values): -0.1734 (97.47% CI -0.1734 to -0.1037), Mixed Models Analysis

Population analysed: Analysis includes participants who completed the study per protocol and had no missing data (n=243).

5 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
Narafilcon A	0 of 127 (0%)	0 of 127 (0%)	Not reported
Nelfilcon A	0 of 121 (0%)	0 of 121 (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.

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Not yet 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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A study testing nelfilcon A and narafilcon A in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 19 sites 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 19 sites 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 18 Feb 2010). 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: at 1 week of wear.). 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 NCT00727558.

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.