Refractive ErrorNCT00708643

Clinical Performance of a New Daily Disposable Contact Lens Worn in an Established Contact Lens Wearing Population

A study testing Habitual Silicone Hydrogel Contact Lens and narafilcon A in people with Refractive Error and Myopia, run by Johnson & Johnson Vision Care, Inc. 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

This study seeks to evaluate the clinical and subjective performance of a new daily disposable soft contact lens. Read more about this study

Who is it for?: Ages 17 years and older
Conditions the study is for: Refractive Error, Myopia
What is being tested?: Habitual Silicone Hydrogel Contact Lens and narafilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteCanada
Study dates: Jun 2008to Sep 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 17 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

They are of legal age (17 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.

Canada1 site

Centre for Contact Lens Research
Waterloo, Ontario, N2L 3G1

Other trials in Canada

About this study

This study seeks to evaluate the clinical and subjective performance of a new daily disposable soft contact lens.

Conditions: Refractive Error, Myopia
Being tested: Habitual Silicone Hydrogel Contact Lens, 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.

Habitual Silicone Hydrogel Contact LensDevice
contact lens
narafilcon ADevice
contact lens

Study groups in NCT00708643
Study group	Role	What they receive
Habitual silicone hydrogel	Active comparator	Habitual contact lens wear. Receives: Device: Habitual Silicone Hydrogel Contact Lens
narafilcon A	Experimental	Silicone hydrogel daily disposable contact lens Receives: Device: narafilcon A

What is being measured

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

Limbal Hyperemia
Measures the redness of the limbal region of the eye on a scale of 0 to 100 grade with 0=none and 100=severe. The analysis is the average grade over all time frames.
Measured: At 2 weeks and 4 weeks
Lens Comfort
Rating of lens comfort by rating agreement to the following statement:
"The lenses I am wearing are comfortable."
Rating using the following scale:
1=strongly agree, 2=agree, 3=neutral, 4=disagree, 5=strongly disagree. The rating is averaged over all time frames.
Measured: At 3,7,10,13,17,21,24, and 27 days
Upper Lid Margin Staining
Measures the trauma to tissue that lines the margin of the inside of the upper eyelid on a 0 to 3 scale, with 0=none to 3=severe. The analysis is the average grade over all time frames.
Measured: At 2 weeks and 4 weeks.

Secondary outcomes (3)

Tarsal Roughness
Measures the amount of roughness to the tissue of the inside upper and lower eyelid on a scale of 0 to 100 with 0=none and 100=severe. The analysis is the average grade over all time frames.
Measured: At 2 weeks and 4 weeks
Tarsal Hyperemia
Measures the amount of redness to the tissue of the inside upper and lower eyelid using a 0 to 100 scale with 0=none and 100=severe.
Measured: At 2 weeks and 4 weeks.
Corneal Staining
A measure of corneal abrasion using a 0 to 100 scale with 0=none, 25=micropunctate, 50=macropunctate, 75=coalescence, 100=patch. The analysis is the average grade over all time frames.
Measured: At 2 weeks and 4 weeks.

Timeline

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

Jun 2008Sep 2008

First posted2 Jul 2008 (estimated)
Study startJun 2008
Primary completionSep 2008
Study completionSep 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 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00708643
Sponsor's protocol ID: CR-0803
Status last verified: May 2015
First submitted: 27 Jun 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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Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
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Evaluation of the Agreement Between Automated Program-Operated Phoropter Subjective Refraction and Optometrist-Performed Subjective Refraction
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Consistency of an Automated Subjective Refraction Program Between Personnel With Diverse Professional Backgrounds and Senior Optometrists
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Evaluation of Orthokeratology Lenses With a 5MM Optic Zone Diameter
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All Refractive Error 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: Clinical Performance of a New Daily Disposable Contact Lens Worn in an Established Contact Lens Wearing Population
ClinicalTrials.gov ID: NCT00708643
Acronym / sponsor ID: CR-0803
Conditions: Refractive Error, Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Collaborators: University of Manchester
Study start: Jun 2008
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 2 Jul 2008 (estimated)
Results: Posted 1 Dec 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 and subjective performance of a new daily disposable soft contact lens.

Study design

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

Arm	Type	Receives
Habitual silicone hydrogel	Active comparator	Device: Habitual Silicone Hydrogel Contact LensHabitual contact lens wear.
narafilcon A	Experimental	Device: narafilcon ASilicone hydrogel daily disposable contact lens

Who may qualify

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

Key inclusion criteria (7 listed)

They are of legal age (17 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
Habitual Silicone Hydrogel Contact Lenscontact lens	Device	Habitual silicone hydrogel
narafilcon Acontact lens	Device	narafilcon A

Primary outcome

Limbal Hyperemia
Time frame: At 2 weeks and 4 weeks
Measures the redness of the limbal region of the eye on a scale of 0 to 100 grade with 0=none and 100=severe. The analysis is the average grade over all time frames.
Lens Comfort
Time frame: At 3,7,10,13,17,21,24, and 27 days
Rating of lens comfort by rating agreement to the following statement: "The lenses I am wearing are comfortable." Rating using the following scale: 1=strongly agree, 2=agree, 3=neutral, 4=disagree, 5=strongly disagree. The rating is averaged over all time frames.
Upper Lid Margin Staining
Time frame: At 2 weeks and 4 weeks.
Measures the trauma to tissue that lines the margin of the inside of the upper eyelid on a 0 to 3 scale, with 0=none to 3=severe. The analysis is the average grade over all time frames.

3 secondary outcomes

Tarsal Roughness
Time frame: At 2 weeks and 4 weeks
Tarsal Hyperemia
Time frame: At 2 weeks and 4 weeks.
Corneal Staining
Time frame: At 2 weeks and 4 weeks.

Results and safety

Results posted to the registry on 1 Dec 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
Habitual Silicone Hydrogel	40	40
Narafilcon A	40	39

Primary outcome: Limbal Hyperemia

Time frame: At 2 weeks and 4 weeks. Least squares mean (Standard Error). Unit: units on a scale

Measure	Habitual Silicone Hydrogel n = 40	Narafilcon A n = 39
Value	34.0967 (1.4982)	31.0920 (1.7271)

Habitual Silicone Hydrogel vs Narafilcon A: Mean Difference (Final Values): -3.0047 (98.75% CI -3.0047 to 2.7153), Mixed Models Analysis

Population analysed: The analysis includes all subjects that completed the study.

Primary outcome: Lens Comfort

Time frame: At 3,7,10,13,17,21,24, and 27 days. Least squares mean (Standard Error). Unit: units on a scale

Measure	Habitual Silicone Hydrogel n = 40	Narafilcon A n = 39
Value	1.1078 (0.4993)	1.0274 (0.5737)

Habitual Silicone Hydrogel vs Narafilcon A: Mean Difference (Final Values): -0.0804 (99% CI -0.0804 to 1.8821), Mixed Models Analysis

Population analysed: The analysis includes all subjects that completed the study.

Primary outcome: Upper Lid Margin Staining

Time frame: At 2 weeks and 4 weeks.. Least squares mean (Standard Error). Unit: units on a scale.

Measure	Habitual Silicone Hydrogel n = 40	Narafilcon A n = 39
Value	0.9358 (1.1146)	1.1586 (1.2857)

Habitual Silicone Hydrogel vs Narafilcon A: Mean Difference (Final Values): 0.2228 (99% CI 0.2228 to 4.6564), Mixed Models Analysis

Population analysed: The analysis includes all subjects that completed the study.

3 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
Habitual Silicone Hydrogel	0 of 40 (0%)	0 of 40 (0%)	Not reported
Narafilcon A	0 of 40 (0%)	0 of 40 (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 Refractive Error

RecruitingPhase 3
A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
Myopia
RecruitingPhase 4
Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
Astigmatism
Not yet recruiting
Evaluation of the Agreement Between Automated Program-Operated Phoropter Subjective Refraction and Optometrist-Performed Subjective Refraction
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Not yet recruiting
Consistency of an Automated Subjective Refraction Program Between Personnel With Diverse Professional Backgrounds and Senior Optometrists
Refractive Errors
Recruiting
Evaluation of Orthokeratology Lenses With a 5MM Optic Zone Diameter
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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?

A study testing Habitual Silicone Hydrogel Contact Lens and narafilcon A in people with Refractive Error and Myopia, run by Johnson & Johnson Vision Care, Inc. at 1 site in Canada.

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 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 1 Dec 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?

Limbal Hyperemia (time frame: At 2 weeks and 4 weeks). The study lists 3 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 NCT00708643.

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.