MyopiaNCT00912028

Clinical Performance Comparison of Several Different Contact Lenses

A study testing senofilcon A, lotrafilcon B and balafilcon A in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 11 sites in Brazil.

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 the study is to evaluate the possible benefits of second generation silicone hydrogel contact lenses. Read more about this study

Who is it for?: Ages 18 to 39 years
Conditions the study is for: Myopia
What is being tested?: senofilcon A, lotrafilcon B and balafilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 71 participants
Where: 11 sitesBrazil
Study dates: 1 May 2009to 1 Feb 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 39 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Subjects must:
be existing soft contact lens wearers of the study control lenses
require a distance visual correction in both eyes
have a contact lens spherical distance requirement between -1.00 diopters (D) and -8.00D in both eyes
have astigmatism less than or equal to 1.00D in both eyes
be able to wear lenses available for this study
be corrected to a visual acuity of 6/9 (20/30) or better in each eye
have normal eyes with no evidence of abnormality or disease

Who cannot join

Subject are excluded for the following reasons:
monovision corrected
worn lenses extended wear in the last 3 months.
require concurrent ocular medication
grade 3 or 4 abnormalities
grade 3 corneal staining in more than two regions

Show all 18Show fewer

anterior ocular surgery
any other ocular surgery or injury within 8 weeks prior to study enrollment
abnormal lachrymal secretions
pre-existing ocular irritation that would preclude contact lens fitting
corneal irregularities
Polymethyl methacrylate (PMMA) or Rigid Gas Permeable (RGP) lens wear in past 12 weeks
any systemic illness which would preclude contact lens wear
diabetes
infectious or immunosuppressive disease
pregnancy or lactating, or planning pregnancy at time or enrollment
participating in a concurrent clinical study or within last 60 days
allergy to the standardized study care solution

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

Brazil11 sites

Study site
Campinas, São Paulo, 13092-320
Study site
Marília, São Paulo, 17519-030
Study site
Maringá, Paraná, 87014-110
Study site
Recife, Pernambuco, 51020-031
Study site
Ribeirão Preto, São Paulo, 14049-900
Study site
Rio de Janeiro, Rio de Janeiro, 22640-100
Study site
Salvador, Estado de Bahia, 41810-570
Study site
Santo André, São Paulo, 09060-650
Study site
São Paulo, São Paulo, 04063-000
Study site
São Paulo, São Paulo, 04534-000
Study site
São Paulo, São Paulo, 05409-001

Other trials in Brazil

About this study

Official title: Multicenter, Single-masked, Randomized, Parallel, Controlled Study to Compare Senofilcon A Contact Lenses to Currently Used Contact Lenses

The purpose of the study is to evaluate the possible benefits of second generation silicone hydrogel contact lenses.

Conditions: Myopia
Being tested: senofilcon A, lotrafilcon B, balafilcon A, methafilcon A, vifilcon A
Medical subject headings: Myopia

What participants receive

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

senofilcon ADevice
contact lens
lotrafilcon BDevice
contact lens
balafilcon ADevice
contact lens
methafilcon ADevice
contact lens
vifilcon ADevice
contact lens

Study groups in NCT00912028
Study group	Role	What they receive
senofilcon A	Active comparator	contact lens Receives: Device: senofilcon A
lotrafilcon B	Active comparator	contact lens Receives: Device: lotrafilcon B
balafilcon A	Active comparator	contact lens Receives: Device: balafilcon A
methafilcon A	Active comparator	contact lens Receives: Device: methafilcon A
vifilcon A	Active comparator	contact lens Receives: Device: vifilcon A

What is being measured

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

Limbal Hyperemia (Redness)
Subject distribution according to limbal hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
Measured: 2 weeks
Limbal Hyperemia (Redness)
Subject distribution according to limbal hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
Measured: 4 weeks
Bulbar Hyperemia (Redness)
Subject distribution according to bulbar hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
Measured: 2 weeks
Bulbar Hyperemia (Redness)
Subject distribution according to bulbar hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
Measured: 4 weeks
Corneal Staining
Subject distribution according to corneal staining with fluorescein scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
Measured: 2 weeks
Corneal Staining
Subject distribution according to corneal staining with fluorescein scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
Measured: 4 weeks

Timeline

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

1 May 20091 Feb 2010

First posted3 Jun 2009 (estimated)
Study start1 May 2009
Primary completion1 Feb 2010
Study completion1 Feb 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: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00912028
Sponsor's protocol ID: AOH--BRA-001
Status last verified: Aug 2017
First submitted: 29 May 2009
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: Multicenter, Single-masked, Randomized, Parallel, Controlled Study to Compare Senofilcon A Contact Lenses to Currently Used Contact Lenses
ClinicalTrials.gov ID: NCT00912028
Acronym / sponsor ID: AOH--BRA-001
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 71 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 1 May 2009 (actual)
Primary completion: 1 Feb 2010 (actual)
Study completion: 1 Feb 2010 (actual)
First posted: 3 Jun 2009 (estimated)
Results: Posted 28 Apr 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 the study is to evaluate the possible benefits of second generation silicone hydrogel contact lenses.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 5

Arm	Type	Receives
senofilcon A	Active comparator	Device: senofilcon Acontact lens
lotrafilcon B	Active comparator	Device: lotrafilcon Bcontact lens
balafilcon A	Active comparator	Device: balafilcon Acontact lens
methafilcon A	Active comparator	Device: methafilcon Acontact lens
vifilcon A	Active comparator	Device: vifilcon Acontact lens

Who may qualify

Ages: 18 to 39 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

be existing soft contact lens wearers of the study control lenses
require a distance visual correction in both eyes
have a contact lens spherical distance requirement between -1.00 diopters (D) and -8.00D in both eyes
have astigmatism less than or equal to 1.00D in both eyes
be able to wear lenses available for this study

Key exclusion criteria (18 listed)

monovision corrected
worn lenses extended wear in the last 3 months.
require concurrent ocular medication
grade 3 or 4 abnormalities
grade 3 corneal staining in more than two regions

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
senofilcon Acontact lens	Device	senofilcon A
lotrafilcon Bcontact lens	Device	lotrafilcon B
balafilcon Acontact lens	Device	balafilcon A
methafilcon Acontact lens	Device	methafilcon A
vifilcon Acontact lens	Device	vifilcon A

Primary outcome

Limbal Hyperemia (Redness)
Time frame: 2 weeks
Subject distribution according to limbal hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
Limbal Hyperemia (Redness)
Time frame: 4 weeks
Subject distribution according to limbal hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
Bulbar Hyperemia (Redness)
Time frame: 2 weeks
Subject distribution according to bulbar hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
Bulbar Hyperemia (Redness)
Time frame: 4 weeks
Subject distribution according to bulbar hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
Corneal Staining
Time frame: 2 weeks
Subject distribution according to corneal staining with fluorescein scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
Corneal Staining
Time frame: 4 weeks
Subject distribution according to corneal staining with fluorescein scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.

Results and safety

Results posted to the registry on 28 Apr 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
Senofilcon A	35	30
Lotrafilcon B	3	0
Balafilcon A	13	13
Methafilcon A	17	16
Vifilcon A	3	0

Primary outcome: Limbal Hyperemia (Redness)

Time frame: 2 weeks. Number. Unit: eyes

Measure	Senofilcon A n = 30	Balafilcon A n = 13	Methafilcon A n = 16
Grade 0	40	14	24
Grade 1	12	4	4
Grade 2	8	8	4
Grade 3	0	0	0
Grade 4	0	0	0

Population analysed: Analysis is on those subjects who were enrolled, randomized, and completed the study.

Primary outcome: Limbal Hyperemia (Redness)

Time frame: 4 weeks. Number. Unit: eyes

Measure	Senofilcon A n = 30	Balafilcon A n = 13	Methafilcon A n = 16
Grade 0	46	16	18
Grade 1	10	4	12
Grade 2	6	4	2
Grade 3	0	0	0
Grade 4	0	0	0

Population analysed: Analysis is on those subjects who are enrolled, randomized to a study arm, and who completed the study.

Primary outcome: Bulbar Hyperemia (Redness)

Time frame: 2 weeks. Number. Unit: eyes

Measure	Senofilcon A n = 30	Balafilcon A n = 13	Methafilcon A n = 16
Grade 0	43	12	20
Grade 1	12	12	8
Grade 2	5	2	4
Grade 3	0	0	0
Grade 4	0	0	0

Primary outcome: Bulbar Hyperemia (Redness)

Time frame: 4 weeks. Number. Unit: eyes

Measure	Senofilcon A n = 30	Balafilcon A n = 13	Methafilcon A n = 16
Grade 0	45	11	23
Grade 1	12	13	9
Grade 2	3	0	0
Grade 3	0	0	0
Grade 4	0	0	0

Population analysed: Analysis is on those who are enrolled, randomized to a study arm, and completed the study.

Adverse events

Time frame: Study period. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Senofilcon A	0 of 35 (0%)	1 of 35 (2.9%)	Not reported
Lotrafilcon B	0 of 3 (0%)	2 of 3 (66.7%)	Not reported
Balafilcon A	0 of 13 (0%)	0 of 13 (0%)	Not reported
Methafilcon A	0 of 17 (0%)	0 of 17 (0%)	Not reported
Vifilcon A	0 of 3 (0%)	1 of 3 (33.3%)	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

Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
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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.

Carlos E Leite Arieta, MD, PhD principal investigator

Associate Professor - Ophthalmolgy, University of Campinas, Brazil

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

Questions about this trial

What is this clinical trial studying?

A study testing senofilcon A, lotrafilcon B and balafilcon A in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 11 sites in Brazil.

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 18 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 11 sites in Brazil. 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 28 Apr 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?

Limbal Hyperemia (Redness) (time frame: 2 weeks). The study lists 6 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 NCT00912028.

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; AzTrials last refreshed its copy on 6 Nov 2026.