MyopiaNCT01482819

Evaluation of Daytime Corneal Swelling During Wear of Galyfilcon A Lenses

A study testing galyfilcon A, galyfilcon A plus 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 study is to evaluate corneal swelling, limbal redness, and endothelial bleb response to wearing galyfilcon A lenses in asian eyes. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myopia
What is being tested?: galyfilcon A, galyfilcon A plus and lotrafilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteAustralia
Study dates: 1 Oct 2011to 1 Dec 2011
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

Be of legal age (i.e. 18 years)
Be of Asian descent and have -Asian eye‖ identifying features (see Appendix A)
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 3 months prior to the trial ) without experiencing difficulties or contact lens related complications

Show all 12Show fewer

Have had an oculo-visual examination within the previous 12 months.
Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
No evidence of lid abnormality or infection
No conjunctival abnormality or infection
No clinically significant slit lamp findings (i.e. edema, staining, scarring, vascularization, infiltrates or abnormal opacities)
No other active ocular disease

Who cannot join

Requires concurrent ocular medication.
Clinically significant (Grade 3 or 4) corneal staining (FDA scale), corneal stromal haze, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
Has had refractive surgery.
Has had any anterior ocular surgery. Has had any other ocular surgery or injury within 8 weeks immediately prior to enrolment for this study.
History of abnormal lachrymal secretions.
Pre-existing ocular irritation that would preclude contact lens fitting.

Show all 17Show fewer

Keratoconus or other corneal irregularity.
Extended lens wear in last 3 months.
PMMA, hybrid or RGP lens wear in the previous 8 weeks
Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
Has diabetes
Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
History of chronic eye disease (e.g. glaucoma or ARMD).
Pregnancy, lactating, or planning a pregnancy at the time of enrolment.
Participation in any concurrent clinical trial or in last 30 days.
Family member or employee of the clinical site, investigator or other study staff.
Currently wears habitual contact lenses on an EW basis.

Trial locations and contacts

1 site in 1 country.

Australia1 site

Study site
Hawthorn, Victoria, 3122

Other trials in Australia

About this study

The purpose of this study is to evaluate corneal swelling, limbal redness, and endothelial bleb response to wearing galyfilcon A lenses in asian eyes.

Conditions: Myopia
Being tested: galyfilcon A, galyfilcon A plus, lotrafilcon A, polymacon, spectacles
Medical subject headings: Myopia

What participants receive

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

galyfilcon ADevice
contact lenses worn bilaterally for 8-12 hours
galyfilcon A plusDevice
contact lenses worn bilaterally for 8-12 hours
lotrafilcon ADevice
contact lenses worn bilaterally for 8-12 hours
polymaconDevice
contact lenses worn bilaterally for 8-12 hours
spectaclesOther
habitual spectacles owned by subject, non-specific manufacturer

Study groups in NCT01482819
Study group	Role	What they receive
Sequence 1	Other	Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: 1. Lotrafilcon A 2. Spectacles 3. Galyfilcon A Plus 4. Polymacon 5. Galyfilcon A Receives: Device: galyfilcon A; Device: galyfilcon A plus; Device: lotrafilcon A; Device: polymacon; Other: spectacles
Sequence 2	Other	Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: 1. Galyfilcon A Plus 2. Galyfilcon A 3. Lotrafilcon A 4. Polymacon 5. Spectacles Receives: Device: galyfilcon A; Device: galyfilcon A plus; Device: lotrafilcon A; Device: polymacon; Other: spectacles
Sequence 3	Other	Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: 1. Galyfilcon A 2. Polymacon 3. Galyfilcon A Plus 4. Spectacles 5. Lotrafilcon A Receives: Device: galyfilcon A; Device: galyfilcon A plus; Device: lotrafilcon A; Device: polymacon; Other: spectacles
Sequence 4	Other	Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: 1. Spectacles 2. Lotrafilcon A 3. Polymacon 4. Galyfilcon A Plus 5. Galyfilcon A Receives: Device: galyfilcon A; Device: galyfilcon A plus; Device: lotrafilcon A; Device: polymacon; Other: spectacles
Sequence 5	Other	Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: 1. Polymacon 2. Galyfilcon A 3. Spectacles 4. Galyfilcon A Plus 5. Lotrafilcon A Receives: Device: galyfilcon A; Device: galyfilcon A plus; Device: lotrafilcon A; Device: polymacon; Other: spectacles
Sequence 6	Other	Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: 1. Galyfilcon A 2. Galyfilcon A Plus 3. Polymacon 4. Lotrafilcon A 5. Spectacles Receives: Device: galyfilcon A; Device: galyfilcon A plus; Device: lotrafilcon A; Device: polymacon; Other: spectacles
Sequence 7	Other	Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: 1. Polymacon 2. Spectacles 3. Galyfilcon A 4. Lotrafilcon A 5. Galyfilcon A Plus Receives: Device: galyfilcon A; Device: galyfilcon A plus; Device: lotrafilcon A; Device: polymacon; Other: spectacles
Sequence 8	Other	Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: 1. Galyfilcon A Plus 2. Lotrafilcon A 3. Galyfilcon A 4. Spectacles 5. Polymacon Receives: Device: galyfilcon A; Device: galyfilcon A plus; Device: lotrafilcon A; Device: polymacon; Other: spectacles
Sequence 9	Other	Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: 1. Lotrafilcon A 2. Galyfilcon A Plus 3. Spectacles 4. Galyfilcon A 5. Polymacon Receives: Device: galyfilcon A; Device: galyfilcon A plus; Device: lotrafilcon A; Device: polymacon; Other: spectacles
Sequence 10	Other	Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: 1. Spectacles 2. Polymacon 3. Lotrafilcon A 4. Galyfilcon A 5. Galyfilcon A Plus Receives: Device: galyfilcon A; Device: galyfilcon A plus; Device: lotrafilcon A; Device: polymacon; Other: spectacles

What is being measured

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

Corneal Swelling
measured in microns using the Optical Low Coherence Reflectometry (OLCR) Pachymeter. This pachymeter gives corneal thickness measurements to the accuracy of 1 micron (µm)
Measured: after 8 hours of lens wear
Limbal Redness
grade scale of 0 to 4, where 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe; reported as an average grade.
Measured: after 8 hours of lens wear
Endothelia Blebs
0 to 100% of area; measured as a percentage of corneal area with blebs.
Measured: after 20 minutes of lens wear

Timeline

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

1 Oct 20111 Dec 2011

First posted1 Dec 2011 (estimated)
Study start1 Oct 2011
Primary completion1 Dec 2011
Study completion1 Dec 2011

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: Factorial
Masking: Single blind
Who is masked: Participant
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01482819
Sponsor's protocol ID: CR-005031
Status last verified: Aug 2017
First submitted: 16 Nov 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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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: Evaluation of Daytime Corneal Swelling During Wear of Galyfilcon A Lenses
ClinicalTrials.gov ID: NCT01482819
Acronym / sponsor ID: CR-005031
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 1 Oct 2011 (actual)
Primary completion: 1 Dec 2011 (actual)
Study completion: 1 Dec 2011 (actual)
First posted: 1 Dec 2011 (estimated)
Results: Posted 30 Apr 2015

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 study is to evaluate corneal swelling, limbal redness, and endothelial bleb response to wearing galyfilcon A lenses in asian eyes.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (participant)
Number of arms: 10

Arm	Type	Receives
Sequence 1	Other	Device: galyfilcon A, Device: galyfilcon A plus, Device: lotrafilcon A, Device: polymacon, Other: spectaclesFive separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: 1. Lotrafilcon A 2. Spectacles 3. Galyfilcon A Plus 4. Polymacon 5. Galyfilcon A
Sequence 2	Other	Device: galyfilcon A, Device: galyfilcon A plus, Device: lotrafilcon A, Device: polymacon, Other: spectaclesFive separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: 1. Galyfilcon A Plus 2. Galyfilcon A 3. Lotrafilcon A 4. Polymacon 5. Spectacles
Sequence 3	Other	Device: galyfilcon A, Device: galyfilcon A plus, Device: lotrafilcon A, Device: polymacon, Other: spectaclesFive separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: 1. Galyfilcon A 2. Polymacon 3. Galyfilcon A Plus 4. Spectacles 5. Lotrafilcon A
Sequence 4	Other	Device: galyfilcon A, Device: galyfilcon A plus, Device: lotrafilcon A, Device: polymacon, Other: spectaclesFive separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: 1. Spectacles 2. Lotrafilcon A 3. Polymacon 4. Galyfilcon A Plus 5. Galyfilcon A
Sequence 5	Other	Device: galyfilcon A, Device: galyfilcon A plus, Device: lotrafilcon A, Device: polymacon, Other: spectaclesFive separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: 1. Polymacon 2. Galyfilcon A 3. Spectacles 4. Galyfilcon A Plus 5. Lotrafilcon A
Sequence 6	Other	Device: galyfilcon A, Device: galyfilcon A plus, Device: lotrafilcon A, Device: polymacon, Other: spectaclesFive separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: 1. Galyfilcon A 2. Galyfilcon A Plus 3. Polymacon 4. Lotrafilcon A 5. Spectacles
Sequence 7	Other	Device: galyfilcon A, Device: galyfilcon A plus, Device: lotrafilcon A, Device: polymacon, Other: spectaclesFive separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: 1. Polymacon 2. Spectacles 3. Galyfilcon A 4. Lotrafilcon A 5. Galyfilcon A Plus
Sequence 8	Other	Device: galyfilcon A, Device: galyfilcon A plus, Device: lotrafilcon A, Device: polymacon, Other: spectaclesFive separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: 1. Galyfilcon A Plus 2. Lotrafilcon A 3. Galyfilcon A 4. Spectacles 5. Polymacon
Sequence 9	Other	Device: galyfilcon A, Device: galyfilcon A plus, Device: lotrafilcon A, Device: polymacon, Other: spectaclesFive separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: 1. Lotrafilcon A 2. Galyfilcon A Plus 3. Spectacles 4. Galyfilcon A 5. Polymacon
Sequence 10	Other	Device: galyfilcon A, Device: galyfilcon A plus, Device: lotrafilcon A, Device: polymacon, Other: spectaclesFive separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows: 1. Spectacles 2. Polymacon 3. Lotrafilcon A 4. Galyfilcon A 5. Galyfilcon A Plus

Who may qualify

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

Key inclusion criteria (12 listed)

Be of legal age (i.e. 18 years)
Be of Asian descent and have -Asian eye‖ identifying features (see Appendix A)
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

Key exclusion criteria (17 listed)

Requires concurrent ocular medication.
Clinically significant (Grade 3 or 4) corneal staining (FDA scale), corneal stromal haze, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
Has had refractive surgery.
Has had any anterior ocular surgery. Has had any other ocular surgery or injury within 8 weeks immediately prior to enrolment for this study.
History of abnormal lachrymal secretions.

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
galyfilcon Acontact lenses worn bilaterally for 8-12 hours	Device	Sequence 1, Sequence 10, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6, Sequence 7, Sequence 8, Sequence 9
galyfilcon A pluscontact lenses worn bilaterally for 8-12 hours	Device	Sequence 1, Sequence 10, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6, Sequence 7, Sequence 8, Sequence 9
lotrafilcon Acontact lenses worn bilaterally for 8-12 hours	Device	Sequence 1, Sequence 10, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6, Sequence 7, Sequence 8, Sequence 9
polymaconcontact lenses worn bilaterally for 8-12 hours	Device	Sequence 1, Sequence 10, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6, Sequence 7, Sequence 8, Sequence 9
spectacleshabitual spectacles owned by subject, non-specific manufacturer	Other	Sequence 1, Sequence 10, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6, Sequence 7, Sequence 8, Sequence 9

Primary outcome

Corneal Swelling
Time frame: after 8 hours of lens wear
measured in microns using the Optical Low Coherence Reflectometry (OLCR) Pachymeter. This pachymeter gives corneal thickness measurements to the accuracy of 1 micron (µm)
Limbal Redness
Time frame: after 8 hours of lens wear
grade scale of 0 to 4, where 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe; reported as an average grade.
Endothelia Blebs
Time frame: after 20 minutes of lens wear
0 to 100% of area; measured as a percentage of corneal area with blebs.

Results and safety

Results posted to the registry on 30 Apr 2015, 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 Subjects	21	19

Primary outcome: Corneal Swelling

Time frame: after 8 hours of lens wear. Mean (Standard Deviation). Unit: microns

Measure	Spectacles n = 19	Galyfilcon A Plus n = 19	Galyfilcon A n = 19	Lotrafilcon A n = 19	Polymacon n = 19
Value	569.42 (36.0709)	574.64 (39.7804)	575.57 (37.6229)	578.99 (41.4960)	573.79 (36.1644)

Population analysed: Subjects who were enrolled, randomized, and completed the study. One eye from each subject was measured.

Primary outcome: Limbal Redness

Time frame: after 8 hours of lens wear. Mean (Standard Deviation). Unit: units on a scale

Measure	Spectacles n = 19	Galyfilcon A Plus n = 19	Galyfilcon A n = 20	Lotrafilcon A n = 20	Polymacon n = 19
Value	0.66 (0.2479)	0.83 (0.3023)	0.77 (0.3085)	0.91 (0.3087)	1.14 (0.3363)

Population analysed: Subjects who were enrolled, randomized, and completed the study.

Primary outcome: Endothelia Blebs

Time frame: after 20 minutes of lens wear. Mean (Standard Deviation). Unit: percentage of area

Measure	Spectacles n = 20	Galyfilcon A Plus n = 19	Galyfilcon A n = 20	Lotrafilcon A n = 20	Polymacon n = 19
Value	4.97 (3.3703)	8.86 (3.9396)	10.93 (6.6020)	10.31 (6.6747)	8.50 (3.6000)

Population analysed: Subjects who were enrolled, randomized and completed the study.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Subjects	0 of 21 (0%)	0 of 21 (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.

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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 galyfilcon A, galyfilcon A plus 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 12 inclusion and 17 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. 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 Apr 2015). 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 Swelling (time frame: after 8 hours of 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 NCT01482819.

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.