Refractive ErrorNCT00634101

A Comparison of Two Daily Disposable Contact Lenses

A study testing nelfilcon A and narafilcon A in people with Refractive Error and Myopia, run by Johnson & Johnson Vision Care, Inc. at 20 sites in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

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: Refractive Error, 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: 129 participants
Where: 20 sitesUnited Kingdom
Study dates: 1 Jan 2008to 1 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 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

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United Kingdom20 sites

Simon Donne Opticians
Bedford, Bedfordshire, MK40 1NS
Boots Opticians Ltd
Birmingham, West Midlands, B4 7TB
Cole Martin Tregaskis Optometrists
Brentwood, Essex, CM15 8AG
Brock & Houlford
Brislington, Bristol, BS4 3LJ
Keith Tempany Opticians
Broadstone, Dorset, BH18 8DH
Chalmers & Sons (Opticians)
Cardiff, South Glamorgan, CF24 3RQ
Specsavers Opticians
Colchester, Essex, CO1 1LJ
Vision Express Optical Lab
Hendon, London, NW4 3FB
City Opticians
Holborn, London, WC2A 1AA
Eyecare
Ilford, Essex, IG1 4DU
Tompkins Knight & Son
Northampton, Northamptonhsire, NN2 7BL
Dipple & Conway Opticians
Norwich, Norfolk, NR2 1PB
First Contact Opticians
Pinner, Middlesex, HA5 1RJ
David Gould Opticians
Rawtenstall, Lancashire, BB4 7QN
Hazel Smith Opticians
Shanklin, Isle Of Wight, PO37 6JZ
Cameron-Davies Optometrists
Southsea, Hants, PO5 2AT
Leightons Opticians
St Albans, Herts, AL1 3LH
David H. Burns, BSC, FCOptom
Tottenham, London, N17 0EY
S.H. Harrold
Uxbridge, Middlesex, UB81JX
Viewpoint
York, YO1 8BA

Other trials in United Kingdom

About this study

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

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: Refractive Error, Myopia
Being tested: nelfilcon A, narafilcon A
Medical subject headings: Refractive Errors, Myopia

What participants receive

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

nelfilcon ADevice
Also called FOCUS DAILIES AquaComfort Plus
contact lens
narafilcon ADevice
Also called Experimental Contact Lens
contact lens

Study groups in NCT00634101
Study group	Role	What they receive
nefilcon A	Active comparator	Subjects randomized to this arm received the nelfilcon A lens throughout the entire duration of the study. Receives: Device: nelfilcon A
narafilcon A	Experimental	Subjects randomized to this arm received the narafilcon A lens throughout the entire duration of the study. Receives: Device: narafilcon A

What is being measured

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

Comfort at the End of the Day
Comfort at the end of the day was assessed by the individual questionnaire item "Comfort at the end of the day" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. EOD Comfort was also assessed by the individual item "How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided?" with the respopnse categories of 1=Extremely Uncomfortable, 2=Very Uncomfortable, 3=Slightly Uncomfortable, 4=Comfortable and 5= Very Comfortable. The number of participants that responsed in each cateogry for each item was reported.
Measured: 1-Week Follow-up
Limbal Hyperaemia
Limbal Hyperaemia was measured using Efron Grading Scale ranges from 0 to 4 with 0.5 units increments (0 = Normal, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe).
Measured: 1-Week Follow-up
Comfort Immediately When You First Put Them on
Comfort immediately when you first put them on was assessed by the individual questionnaire item "Comfort immediately when you first put them on" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.
Measured: 1-Week Follow-up
Comfort Throughout the Day
Comfort throughout the day was assessed by the individual questionnaire item "Comfort throughout the day" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.
Measured: 1-Week Follow-up
Lack of Dryness at the End of the Day
Lack of dryness at the end of the day was assessed by the individual questionnaire item "Not making your eyes feel dry even at the end of the day" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.
Measured: 1-Week Follow-up
Overall Opinion
Overall opinion was assessed by the individual questionnaire item "Considering your experience with the contact lenses you were provided, which statement best describes your overall opinion of these contact lenses? " with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.
Measured: 1-Week Follow-up
Overall Comfort
Overall comfort was assessed by the individual questionnaire item "Overall Comfort" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.
Measured: 1-Week Follow-up
My Lenses Stayed Moist
My Lenses Stayed Moist was assessed by the individual questionnaire item "They stayed moist and smooth, even after long hours at the computer" with the response cateogries 1=Disagree Strongly, 2=Disagree Somewhat, 3=Neither Agree Nor Disagree, 4=Very Somewhat and 5=Agree Strongly. The number of participants that responsed in each cateogry was reported.
Measured: 1-Week Follow-up
I Forgot i Was Wearing Lenses Was
I forgot i was wearing lenses was assessed by the individual questionnaire item "They made me forget that I was wearing contact lenses" with the response cateogries 1=Disagree Strongly, 2=Disagree Somewhat, 3=Neither Agree Nor Disagree, 4=Very Somewhat and 5=Agree Strongly. The number of participants that responsed in each cateogry was reported.
Measured: 1-Week Follow-up
Mainted Natural Moisture
Mainted natural moisture was assessed by the individual questionnaire item "They maintained my eyes' own natural moisture" with the response cateogries 1=Disagree Strongly, 2=Disagree Somewhat, 3=Neither Agree Nor Disagree, 4=Very Somewhat and 5=Agree Strongly. The number of participants that responsed in each cateogry was reported.
Measured: 1-Week Follow-up
Comfort While Wearing Lenses in Heat/Air Conditioned Environments
Comfort while wearing lenses in heat/air conditioned environments was assessed by the individual questionnaire item "How often are you comfortable while sitting under or near an air conditioning vent or heating vent " with the response cateogries 0=Not Applicable, 1=Always, 2=Frequently, 3=Occasionally, 4=Rarely and 5=never. The number of participants that responsed in each cateogry was reported.
Measured: 1-Week Follow-up
Dryness at the End of the Day
Dryness at the end of the day was assessed by the individual questionnaire item "How dry did your eyes feel at the end of the day when wearing the contact lenses you were provided" with the response cateogries 1=Extremely Dry, 2=Very Dry, 3=Moderately Dry, 4=Slightly Dry and 5=Not Dry at All. The number of participants that responsed in each cateogry was reported.
Measured: 1-Week Follow-up

Secondary outcomes (1)

Overall Handling
Handling was assessed through opinion of handling in the final questionnaire. There were 5 categories Excellent (5), Very Good (4), Good (3), Fair (2) and Poor (1).
Measured: 1-Week Follow-up

Timeline

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

1 Jan 20081 Mar 2008

First posted12 Mar 2008 (estimated)
Study start1 Jan 2008
Primary completion1 Mar 2008
Study completion1 Mar 2008

Why it stopped: Study was resurrected as NCT00727558 (CR-0808)

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.
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: 129 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00634101
Sponsor's protocol ID: CR-0716
Other IDs: DISP-519
Status last verified: Dec 2020
First submitted: 28 Feb 2008
Last updated: 6 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

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 Refractive Error trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Comparative Clinical Performance of Narafilcon A and the FOCUS DAILIES AquaComfort Plus Lens
ClinicalTrials.gov ID: NCT00634101
Acronym / sponsor ID: CR-0716
Conditions: Refractive Error, Myopia
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study was resurrected as NCT00727558 (CR-0808)
Enrolment: 129 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Collaborators: Visioncare Research Ltd.
Study start: 1 Jan 2008 (actual)
Primary completion: 1 Mar 2008 (actual)
Study completion: 1 Mar 2008 (actual)
First posted: 12 Mar 2008 (estimated)
Results: Posted 14 Oct 2020

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
nefilcon A	Active comparator	Device: nelfilcon ASubjects randomized to this arm received the nelfilcon A lens throughout the entire duration of the study.
narafilcon A	Experimental	Device: narafilcon ASubjects randomized to this arm received the narafilcon A lens throughout the entire duration of the study.

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 AAlso: FOCUS DAILIES AquaComfort Pluscontact lens	Device	nefilcon A
narafilcon AAlso: Experimental Contact Lenscontact lens	Device	narafilcon A

Primary outcome

Comfort at the End of the Day
Time frame: 1-Week Follow-up
Comfort at the end of the day was assessed by the individual questionnaire item "Comfort at the end of the day" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. EOD Comfort was also assessed by the individual item "How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided?" with the respopnse categories of 1=Extremely Uncomfortable, 2=Very Uncomfortable, 3=Slightly Uncomfortable, 4=Comfortable and 5= Very Comfortable. The number of participants that responsed in each cateogry for each item was reported.
Limbal Hyperaemia
Time frame: 1-Week Follow-up
Limbal Hyperaemia was measured using Efron Grading Scale ranges from 0 to 4 with 0.5 units increments (0 = Normal, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe).
Comfort Immediately When You First Put Them on
Time frame: 1-Week Follow-up
Comfort immediately when you first put them on was assessed by the individual questionnaire item "Comfort immediately when you first put them on" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.
Comfort Throughout the Day
Time frame: 1-Week Follow-up
Comfort throughout the day was assessed by the individual questionnaire item "Comfort throughout the day" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.
Lack of Dryness at the End of the Day
Time frame: 1-Week Follow-up
Lack of dryness at the end of the day was assessed by the individual questionnaire item "Not making your eyes feel dry even at the end of the day" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.
Overall Opinion
Time frame: 1-Week Follow-up
Overall opinion was assessed by the individual questionnaire item "Considering your experience with the contact lenses you were provided, which statement best describes your overall opinion of these contact lenses? " with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.
Overall Comfort
Time frame: 1-Week Follow-up
Overall comfort was assessed by the individual questionnaire item "Overall Comfort" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.
My Lenses Stayed Moist
Time frame: 1-Week Follow-up
My Lenses Stayed Moist was assessed by the individual questionnaire item "They stayed moist and smooth, even after long hours at the computer" with the response cateogries 1=Disagree Strongly, 2=Disagree Somewhat, 3=Neither Agree Nor Disagree, 4=Very Somewhat and 5=Agree Strongly. The number of participants that responsed in each cateogry was reported.
I Forgot i Was Wearing Lenses Was
Time frame: 1-Week Follow-up
I forgot i was wearing lenses was assessed by the individual questionnaire item "They made me forget that I was wearing contact lenses" with the response cateogries 1=Disagree Strongly, 2=Disagree Somewhat, 3=Neither Agree Nor Disagree, 4=Very Somewhat and 5=Agree Strongly. The number of participants that responsed in each cateogry was reported.
Mainted Natural Moisture
Time frame: 1-Week Follow-up
Mainted natural moisture was assessed by the individual questionnaire item "They maintained my eyes' own natural moisture" with the response cateogries 1=Disagree Strongly, 2=Disagree Somewhat, 3=Neither Agree Nor Disagree, 4=Very Somewhat and 5=Agree Strongly. The number of participants that responsed in each cateogry was reported.
Comfort While Wearing Lenses in Heat/Air Conditioned Environments
Time frame: 1-Week Follow-up
Comfort while wearing lenses in heat/air conditioned environments was assessed by the individual questionnaire item "How often are you comfortable while sitting under or near an air conditioning vent or heating vent " with the response cateogries 0=Not Applicable, 1=Always, 2=Frequently, 3=Occasionally, 4=Rarely and 5=never. The number of participants that responsed in each cateogry was reported.
Dryness at the End of the Day
Time frame: 1-Week Follow-up
Dryness at the end of the day was assessed by the individual questionnaire item "How dry did your eyes feel at the end of the day when wearing the contact lenses you were provided" with the response cateogries 1=Extremely Dry, 2=Very Dry, 3=Moderately Dry, 4=Slightly Dry and 5=Not Dry at All. The number of participants that responsed in each cateogry was reported.

1 secondary outcome

Overall Handling
Time frame: 1-Week Follow-up

Results and safety

Results posted to the registry on 14 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test (Narafilcon A)	66	61
Control (Nelfilcon A)	59	56

Primary outcome: Comfort at the End of the Day

Time frame: 1-Week Follow-up. Count of participants. Unit: Participants

Measure	Test (Narafilcon A) n = 53	Control (Nelfilcon A) n = 49
Comfort EOD: 5	8	7
Comfort EOD: 4	17	12
Comfort EOD: 3	10	15
Comfort EOD: 2	5	8
Comfort EOD: 1	13	7
Comfort EOD: Intentionally Left Blank	0	0
Eye Comfort EOD: 5	14	7
Eye Comfort EOD: 4	13	16

Population analysed: All available data at the 1-Week follow-up.

Primary outcome: Limbal Hyperaemia

Time frame: 1-Week Follow-up. Count of units. Unit: eyes

Measure	Test (Narafilcon A) n = 61	Control (Nelfilcon A) n = 56
Grade 0	72	54
Grade 0.5	26	34
Grade 1	15	8
Grade 1.5	0	8
Grade 2	4	5
Grade 2.5	4	3
Grade 3	1	0
Grade 3.5	0	0

Population analysed: All available data at the 1-Week follow-up.

Primary outcome: Comfort Immediately When You First Put Them on

Time frame: 1-Week Follow-up. Count of participants. Unit: Participants

Measure	Test (Narafilcon A) n = 53	Control (Nelfilcon A) n = 49
Excellent (5)	13	19
Very Good (4)	22	13
Good (3)	8	8
Fair (2)	6	7
Poor (1)	4	2

Population analysed: All available data at the 1-Week follow-up.

Primary outcome: Comfort Throughout the Day

Time frame: 1-Week Follow-up. Count of participants. Unit: Participants

Measure	Test (Narafilcon A) n = 53	Control (Nelfilcon A) n = 49
Excellent (5)	13	19
Very Good (4)	22	13
Good (3)	8	8
Fair (2)	6	7
Poor (1)	4	2

Population analysed: All available data at the 1-Week follow-up.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Throughout the duration of this study. Approximately 1 week per subject.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test (Narafilcon A)	0 of 66 (0%)	0 of 66 (0%)	0 of 66
Control (Nelfilcon A)	0 of 59 (0%)	0 of 59 (0%)	0 of 59

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
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.

20 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 Refractive Error and Myopia, run by Johnson & Johnson Vision Care, Inc. at 20 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: stopped early, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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 14 Oct 2020). 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?

Comfort at the End of the Day (time frame: 1-Week Follow-up). The study lists 12 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 NCT00634101.

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 6 Jan 2021.