MyopiaNCT01444287

Daytime Corneal Swelling During Wear of Narafilcon B Lenses

A study testing narafilcon B, Polymacon and Lotrafilcon A in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 1 site in Australia.

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 research is to measure daytime open-eye response to wearing of narafilcon B lenses. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Myopia
What is being tested?: narafilcon B, Polymacon and Lotrafilcon A
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 22 participants
Where: 1 siteAustralia
Study dates: Jan 2010to Mar 2010
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Be of legal age (i.e. ≥ 18 years).
Be mentally competent, willing and able to sign a written informed consent form.
Have contact lens distance sphere requirement in the range -1.00D to -6.00D.
Have spectacle astigmatism <1.25D in each eye.
Currently wear soft contact lenses (for at least 6 months prior to the trial) with documentation of current prescription.
Have normal eyes with no evidence of abnormality or disease. For the purpose of this study a normal eye is defined as one having: i) no evidence of lid abnormality or infection; ii) no conjunctival abnormality or infection; iii) no clinically significant slit lamp findings (i.e, edema, staining, scarring, vascularization, infiltrates or abnormal opacities); iv) no other active ocular disease.

Who cannot join

Required concurrent ocular medication.
Any systemic illness which would contra-indicate lens wear or the medical treatment of which would affect vision or successful lens wear.
Eye injury or surgery within eight weeks immediately prior to enrollment for this study.
Abnormal lacrimal secretions.
Pre-existing ocular irritation that would preclude contact lens fitting.
Keratoconus or other corneal irregularity.
Pregnancy, lactating or planning a pregnancy at the time of enrollment.
Participation in any concurrent clinical trial.

Trial locations and contacts

1 site in 1 country.

Australia1 site

Coles-Brennan Pty Ltd
Hawthorn, Victoria

Other trials in Australia

About this study

The purpose of this research is to measure daytime open-eye response to wearing of narafilcon B lenses.

Conditions: Myopia
Being tested: narafilcon B, Polymacon, Lotrafilcon A, Spectacles
Medical subject headings: Myopia

What participants receive

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

narafilcon BDevice
test product
PolymaconDevice
marketed product
Lotrafilcon ADevice
marketed product
SpectaclesOther
None - subject used own spectacles

Study groups in NCT01444287
Study group	Role	What they receive
Spectacles No Lenses	Placebo comparator	Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations. Receives: Other: Spectacles
narafilcon B	Experimental	Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations. Receives: Device: narafilcon B
polymacon	Active comparator	Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations. Receives: Device: Polymacon
lotrafilcon A	Active comparator	Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations. Receives: Device: Lotrafilcon A

What is being measured

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

Corneal Thickness
Percentage of corneal swelling (positive value) or deswelling (negative value) measured with Haag-Streit pachymetry equipment in microns, reported as a percent.
Measured: After 8 hours of contact lens wear
Endothelial Blebs
Corneal images captured with equipment are measured, manually outlined to estimate total bleb area from 0 to 100%. This is measured as a change in percentage after 20 minutes compared to the value prior to lens wear (baseline).
Measured: baseline, after 20 minutes of treatment conditions
Limbal Redness
Scale of 0 to 4, where 0=none and 4= severe redness. Measure reported as a comparison of 8 hours of wear to baseline with the difference being reported.
Measured: Baseline, After 8 hours of treatment conditions

Secondary outcomes (1)

Overall Comfort
Patient reported subjective comfort of lenses or spectacles (range 0-100, where 100 is best).
Measured: after 8 hours

Timeline

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

Jan 2010Mar 2010

First posted30 Sep 2011 (estimated)
Study startJan 2010
Primary completionFeb 2010
Study completionMar 2010

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: Double blind
Who is masked: Participant, Investigator
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01444287
Sponsor's protocol ID: CR-0918 (JKN 0927)
Status last verified: May 2015
First submitted: 27 Sep 2011
Last updated: 19 Jun 2018
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 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Daytime Corneal Swelling During Wear of Narafilcon B Lenses
ClinicalTrials.gov ID: NCT01444287
Acronym / sponsor ID: CR-0918 (JKN 0927)
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: Jan 2010
Primary completion: Feb 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 30 Sep 2011 (estimated)
Results: Posted 30 May 2014

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 research is to measure daytime open-eye response to wearing of narafilcon B lenses.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Spectacles No Lenses	Placebo comparator	Other: SpectaclesAssigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
narafilcon B	Experimental	Device: narafilcon BAssigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
polymacon	Active comparator	Device: PolymaconAssigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
lotrafilcon A	Active comparator	Device: Lotrafilcon AAssigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Be of legal age (i.e. ≥ 18 years).
Be mentally competent, willing and able to sign a written informed consent form.
Have contact lens distance sphere requirement in the range -1.00D to -6.00D.
Have spectacle astigmatism <1.25D in each eye.
Currently wear soft contact lenses (for at least 6 months prior to the trial) with documentation of current prescription.

Key exclusion criteria (8 listed)

Required concurrent ocular medication.
Any systemic illness which would contra-indicate lens wear or the medical treatment of which would affect vision or successful lens wear.
Eye injury or surgery within eight weeks immediately prior to enrollment for this study.
Abnormal lacrimal secretions.
Pre-existing ocular irritation that would preclude contact lens fitting.

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
narafilcon Btest product	Device	narafilcon B
Polymaconmarketed product	Device	polymacon
Lotrafilcon Amarketed product	Device	lotrafilcon A
SpectaclesNone - subject used own spectacles	Other	Spectacles No Lenses

Primary outcome

Corneal Thickness
Time frame: After 8 hours of contact lens wear
Percentage of corneal swelling (positive value) or deswelling (negative value) measured with Haag-Streit pachymetry equipment in microns, reported as a percent.
Endothelial Blebs
Time frame: baseline, after 20 minutes of treatment conditions
Corneal images captured with equipment are measured, manually outlined to estimate total bleb area from 0 to 100%. This is measured as a change in percentage after 20 minutes compared to the value prior to lens wear (baseline).
Limbal Redness
Time frame: Baseline, After 8 hours of treatment conditions
Scale of 0 to 4, where 0=none and 4= severe redness. Measure reported as a comparison of 8 hours of wear to baseline with the difference being reported.

1 secondary outcome

Overall Comfort
Time frame: after 8 hours

Results and safety

Results posted to the registry on 30 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Study Participants	22	22

Primary outcome: Corneal Thickness

Time frame: After 8 hours of contact lens wear. Least squares mean (Standard Error). Unit: Percent Change

Measure	Spectacles No Lenses n = 22	Narafilcon B n = 22	Polymacon n = 22	Lotrafilcon A n = 22
Value	-0.35 (0.15)	-0.99 (0.18)	0.75 (0.21)	-1.02 (0.23)

Spectacles No Lenses vs Narafilcon B: Mean Difference (Final Values): 0.636, p = 0.0035, Mixed Models Analysis
Narafilcon B vs Polymacon: Mean Difference (Final Values): 1.743, p = 0.0000, Mixed Models Analysis
Narafilcon B vs Lotrafilcon A: Mean Difference (Final Values): -0.0275, p = 0.8957, Mixed Models Analysis

Population analysed: Subjects are those enrolled and randomized to a trial arm.

Primary outcome: Endothelial Blebs

Time frame: baseline, after 20 minutes of treatment conditions. Mean (Standard Error). Unit: percentage of bleb area

Measure	Spectacles No Lenses n = 22	Narafilcon B n = 22	Polymacon n = 22	Lotrafilcon A n = 22
Value	-0.13 (0.31)	0.49 (0.23)	0.41 (0.40)	0.38 (0.41)

Spectacles No Lenses vs Narafilcon B: Mean Difference (Final Values): -0.0057, p = 0.0692, Mixed Models Analysis
Narafilcon B vs Polymacon: Mean Difference (Final Values): -0.0011, p = 0.7301, Mixed Models Analysis
Narafilcon B vs Lotrafilcon A: Mean Difference (Final Values): -0.0008, p = 0.8055, Mixed Models Analysis

Primary outcome: Limbal Redness

Time frame: Baseline, After 8 hours of treatment conditions. Least squares mean (Standard Error). Unit: units on a scale

Measure	Spectacles No Lenses (Control) n = 22	Narafilcon B (Test) n = 22	Polymacon (+ Control) n = 22	Lotrafilcon A (Control) n = 22
Value	-0.03 (0.06)	-0.04 (0.5)	0.64 (0.10)	0.13 (0.08)

Spectacles No Lenses (Control) vs Narafilcon B (Test): Mean Difference (Final Values): 0.0122, p = 0.9127, Mixed Models Analysis
Narafilcon B (Test) vs Polymacon (+ Control): Mean Difference (Final Values): 0.6864, p = 0.0000, Mixed Models Analysis
Narafilcon B (Test) vs Lotrafilcon A (Control): Mean Difference (Final Values): 0.1705, p = 0.1256, Mixed Models Analysis

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Spectacles No Lenses	0 of 22 (0%)	0 of 22 (0%)	Not reported
Narafilcon B	0 of 22 (0%)	0 of 22 (0%)	Not reported
Polymacon A	0 of 22 (0%)	0 of 22 (0%)	Not reported
Lotrafilcon A	0 of 22 (0%)	0 of 22 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Myopia

Recruiting
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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
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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.

Noel Brennan, McOptom PhD principal investigator

Coles-Brennan Pty Ltd

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

Questions about this trial

What is this clinical trial studying?

A study testing narafilcon B, Polymacon and Lotrafilcon A in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 1 site in Australia.

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 6 inclusion and 8 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 19 Jun 2018. 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 Australia. 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. Some participants in this study may receive a placebo. 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 30 May 2014). 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?

Corneal Thickness (time frame: After 8 hours of contact lens wear). 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 NCT01444287.

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 19 Jun 2018.