MyopiaNCT01244529

Comparison of Lens Fit and Lens Power of a New Contact Lens to Two Marketed Contact Lenses in a Population of Soft Contact Lens Wearers

A study testing galy A Plus, seno A and galy A in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 2 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

The purpose of this study is to evaluate the comparability of lens fit and lens power of a new contact lens to the lens fit and lens power of two marketed lenses. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Myopia
What is being tested?: galy A Plus, seno A and galy A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 2 sitesUnited Kingdom
Study dates: 1 Sep 2010to 1 Nov 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 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Must be at least 18 years of age and no more than 55 years of age.
Must sign written informed consent.
Optimal spherical equivalent distance correction must be between -1.00 and -6.00 diopters.
Have spectacle astigmatism ≤ -0.75 diopter cylinder in both eyes.
Must have visual acuity best correctable to 20/25+3 or better for each eye.
Must appear able and willing to adhere to the instructions set forth in this clinical protocol.
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 clinical significant slit lamp findings, (i.e., oedema, staining, scarring, vascularization, infiltrates or abnormal opacities); No other active ocular disease.
The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of daily wear for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study.

Who cannot join

Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
Any previous eye surgery involving the anterior segment.
Pre-existing ocular disease that would preclude contact lens fitting.
Abnormal lacrimal secretions.
Keratoconus or other corneal irregularity.
Pregnancy, lactating or planning a pregnancy at the time of enrollment.

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Participation in any concurrent clinical trial.
Subject's habitual contact lens type is toric or multifocal.
Require any concurrent ocular medication.

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

Study site
Birmingham, B4 7ET
Study site
Farnham, Surrey, GU9 7EN

Other trials in United Kingdom

About this study

The purpose of this study is to evaluate the comparability of lens fit and lens power of a new contact lens to the lens fit and lens power of two marketed lenses.

Conditions: Myopia
Being tested: galy A Plus, seno A, galy A
Medical subject headings: Myopia

What participants receive

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

galy A PlusDevice
galyfilcon A Plus, BC: 8.3 or 8.7
seno ADevice
senofilcon A, BC:8.4 or 8.8
galy ADevice
galyfilcon A , BC: 8.3 or 8.7

Study groups in NCT01244529
Study group	Role	What they receive
galy A Plus/ galy A / seno A	Other	Pair 1: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 2: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 3: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8). Receives: Device: galy A Plus; Device: seno A; Device: galy A
galy A Plus / seno A / galy A	Other	Pair 1: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 2: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8). Pair 3: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Receives: Device: galy A Plus; Device: seno A; Device: galy A
galy A / galy A Plus / seno A	Other	Pair 1: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 2: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 3: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8). Receives: Device: galy A Plus; Device: seno A; Device: galy A
galy A / seno A / galy A Plus	Other	Pair 1: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 2: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8). Pair 3: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Receives: Device: galy A Plus; Device: seno A; Device: galy A
seno A / galy A / glay A Plus	Other	Pair 1: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8). Pair 2: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 3: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Receives: Device: galy A Plus; Device: seno A; Device: galy A
seno A / galy A Plus / galy A	Other	Pair 1: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8). Pair 2: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 3: galy A -subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Receives: Device: galy A Plus; Device: seno A; Device: galy A

What is being measured

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

Lens Centration Acceptance
Investigator evaluated as acceptable (centered/slightly decentered) or unacceptable (substantially decentered). Number of eyes in each category will be reported by lens. This is an aggregate reporting of the lenses, combining the different base curves into a category by lens type. This is done per protocol, due to this primary outcome not being stratified by base curve.
Measured: after 15 minutes of contact lens wear
Primary Gaze Lens Movement
Investigator evaluated as acceptable (minimal or moderate movement) or unacceptable (insufficient or excessive movement). Percent of eyes in each category will be evaluated.
Measured: after 15 minutes of contact lens wear
Fit Acceptability
Investigator evaluated lens fit using a six point scale: 5-optimal...3-borderline acceptable...2-unacceptable. Percent of eyes in each category will be evaluated.
Measured: after 15 minutes of contact lens wear

Secondary outcomes (1)

New Lens Power Fit Match to Control Lenses
The lens power fit of test lenses will be compared to control lenses to determine if the power matches. Percent of eyes with exact power fit will be evaluated.
Measured: after 15 minutes of contact lens wear

Timeline

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

1 Sep 20101 Nov 2010

First posted19 Nov 2010 (estimated)
Study start1 Sep 2010
Primary completion1 Nov 2010
Study completion1 Nov 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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01244529
Sponsor's protocol ID: CR-201011
Status last verified: Aug 2017
First submitted: 17 Nov 2010
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: Comparison of Lens Fit and Lens Power of a New Contact Lens to Two Marketed Contact Lenses in a Population of Soft Contact Lens Wearers
ClinicalTrials.gov ID: NCT01244529
Acronym / sponsor ID: CR-201011
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 1 Sep 2010 (actual)
Primary completion: 1 Nov 2010 (actual)
Study completion: 1 Nov 2010 (actual)
First posted: 19 Nov 2010 (estimated)
Results: Posted 24 Jan 2012

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 the comparability of lens fit and lens power of a new contact lens to the lens fit and lens power of two marketed lenses.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
galy A Plus/ galy A / seno A	Other	Device: galy A Plus, Device: seno A, Device: galy APair 1: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 2: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 3: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
galy A Plus / seno A / galy A	Other	Device: galy A Plus, Device: seno A, Device: galy APair 1: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 2: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8). Pair 3: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
galy A / galy A Plus / seno A	Other	Device: galy A Plus, Device: seno A, Device: galy APair 1: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 2: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 3: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
galy A / seno A / galy A Plus	Other	Device: galy A Plus, Device: seno A, Device: galy APair 1: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 2: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8). Pair 3: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
seno A / galy A / glay A Plus	Other	Device: galy A Plus, Device: seno A, Device: galy APair 1: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8). Pair 2: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 3: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
seno A / galy A Plus / galy A	Other	Device: galy A Plus, Device: seno A, Device: galy APair 1: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8). Pair 2: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 3: galy A -subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Must be at least 18 years of age and no more than 55 years of age.
Must sign written informed consent.
Optimal spherical equivalent distance correction must be between -1.00 and -6.00 diopters.
Have spectacle astigmatism ≤ -0.75 diopter cylinder in both eyes.
Must have visual acuity best correctable to 20/25+3 or better for each eye.

Key exclusion criteria (9 listed)

Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
Any previous eye surgery involving the anterior segment.
Pre-existing ocular disease that would preclude contact lens fitting.
Abnormal lacrimal secretions.
Keratoconus or other corneal irregularity.

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
galy A Plusgalyfilcon A Plus, BC: 8.3 or 8.7	Device	galy A / galy A Plus / seno A, galy A / seno A / galy A Plus, galy A Plus / seno A / galy A, galy A Plus/ galy A / seno A, seno A / galy A / glay A Plus, seno A / galy A Plus / galy A
seno Asenofilcon A, BC:8.4 or 8.8	Device	galy A / galy A Plus / seno A, galy A / seno A / galy A Plus, galy A Plus / seno A / galy A, galy A Plus/ galy A / seno A, seno A / galy A / glay A Plus, seno A / galy A Plus / galy A
galy Agalyfilcon A , BC: 8.3 or 8.7	Device	galy A / galy A Plus / seno A, galy A / seno A / galy A Plus, galy A Plus / seno A / galy A, galy A Plus/ galy A / seno A, seno A / galy A / glay A Plus, seno A / galy A Plus / galy A

Primary outcome

Lens Centration Acceptance
Time frame: after 15 minutes of contact lens wear
Investigator evaluated as acceptable (centered/slightly decentered) or unacceptable (substantially decentered). Number of eyes in each category will be reported by lens. This is an aggregate reporting of the lenses, combining the different base curves into a category by lens type. This is done per protocol, due to this primary outcome not being stratified by base curve.
Primary Gaze Lens Movement
Time frame: after 15 minutes of contact lens wear
Investigator evaluated as acceptable (minimal or moderate movement) or unacceptable (insufficient or excessive movement). Percent of eyes in each category will be evaluated.
Fit Acceptability
Time frame: after 15 minutes of contact lens wear
Investigator evaluated lens fit using a six point scale: 5-optimal...3-borderline acceptable...2-unacceptable. Percent of eyes in each category will be evaluated.

1 secondary outcome

New Lens Power Fit Match to Control Lenses
Time frame: after 15 minutes of contact lens wear

Results and safety

Results posted to the registry on 24 Jan 2012, 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 Arms, All Interventions	41	41

Primary outcome: Lens Centration Acceptance

Time frame: after 15 minutes of contact lens wear. Number. Unit: eyes

Measure	Galyfilcon A Plus (Test) n = 41	Galyfilcon A (Control) n = 41	Senofilcon A n = 41
Acceptable centration	74	62	69
Unacceptable centration	8	20	13

Population analysed: Analysis was on those completed subjects who were enrolled, randomized, and assigned to a study arm.

Primary outcome: Primary Gaze Lens Movement

Time frame: after 15 minutes of contact lens wear. Number. Unit: percentage of eyes

Measure	Galyfilcon AP 8.3 BC n = 41	Galyfilcon A 8.3 BC n = 41	Senofilcon A 8.4 BC n = 41	Galyfilcon AP 8.7 BC n = 41	Galyfilcon A 8.7 BC n = 41	Senofilcon A 8.8 BC n = 41
Acceptable movement	93	93	100	93	90	98
Unacceptable movement	7	7	0	7	10	2

Population analysed: Analysis was on those completed subjects who were enrolled, randomized, and assigned to a study arm.

Primary outcome: Fit Acceptability

Time frame: after 15 minutes of contact lens wear. Number. Unit: percentage of eyes

Measure	Galyfilcon AP 8.3 BC n = 41	Galyfilcon A 8.3 BC n = 41	Senofilcon A 8.4 BC n = 41	Galyfilcon AP 8.7 BC n = 41	Galyfilcon A 8.7 BC n = 41	Senofilcon A 8.8 BC n = 41
Acceptable Fit	90	90	95	83	71	80
Unacceptable Fit	10	10	5	17	29	20

Population analysed: Analysis was on those completed subjects who were enrolled, randomized, and assigned to a study arm.

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
All Arms, All Interventions	0 of 41 (0%)	0 of 41 (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.

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

Questions about this trial

What is this clinical trial studying?

A study testing galy A Plus, seno A and galy A in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 2 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 8 inclusion and 9 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 2 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 24 Jan 2012). 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?

Lens Centration Acceptance (time frame: after 15 minutes 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 NCT01244529.

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.