AstigmatismNCT00762502

Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period

A study testing senofilcon A toric contact lens and balafilcon A toric contact lens in people with Astigmatism, run by Johnson & Johnson Vision Care, Inc. at 8 sites in 2 countries.

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

To evaluate two toric contact lenses on the ocular physiology of existing contact lens wearers when used in an extended wear modality of days/six nights. Read more about this study

Who is it for?: Ages 18 to 45 years
Conditions the study is for: Astigmatism
What is being tested?: senofilcon A toric contact lens and balafilcon A toric contact lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 112 participants
Where: 8 sitesin 2 countries
Study dates: Jun 2007to Jan 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 18 to 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Able to wear study lenses in parameters available
Non-presbyopes between the ages of 18-45
Understand and sign informed consent
Willing to follow the protocol
Achieve at least 20/30 (6/9) visual acuity (VA) in right eye (OD) and left eye (OS) with study lenses
Myopia -0.75 to -6.25, cylinder -0.75 to -1.50 diopters (D) (axis 90 +/- 15, 180 +/- 15) or -1.75 D (axis 90 +/- 10, 180 +/- 10)

Show all 9Show fewer

Adapted soft contact lens wearer
Swims no more than once a week
Has a wearable pair of spectacles.

Who cannot join

Any ocular or systemic disorder which may contraindicate contact lens wear
Any topical ocular medication
Aphakic
Corneal refractive surgery
Corneal distortion from hard CL wear or keratoconus
Pregnant or lactating

Show all 13Show fewer

Grade 2 or worse slit lamp signs
Infectious disease
Previous clinical study within 2 weeks
Don't agree to participate
Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in last 8 weeks
Previous adverse effects that contraindicate extended lens wear.
Self-reported symptoms of itchiness or scratchiness with habitual lenses.

Trial locations and contacts

8 sites in 2 countries.

Country

City, postcode or hospital

8 sites in 2 countries

Australia7 sites

Study site
Camberwell, Victoria, 3124
Study site
Hawthorn, Victoria, 3122
Study site
Keilor, Victoria, 3036
Study site
Melbourne, Victoria, 3000
Study site
Mitcham, Victoria, 3132
Study site
Newtown, New South Wales, 2042
Study site
Yallourn, Victoria, 3825

Other trials in Australia

United States1 site

Study site
Boston, Massachusetts, 021115

Other trials in United States

About this study

To evaluate two toric contact lenses on the ocular physiology of existing contact lens wearers when used in an extended wear modality of days/six nights.

Conditions: Astigmatism
Being tested: senofilcon A toric contact lens, balafilcon A toric contact lens
Medical subject headings: Astigmatism

What participants receive

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

senofilcon A toric contact lensDevice
soft contact lens
balafilcon A toric contact lensDevice
soft contact lens

Study groups in NCT00762502
Study group	Role	What they receive
senofilcon A toric bilaterally	Active comparator	senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. Receives: Device: senofilcon A toric contact lens
balafilcon A toric bilaterally	Active comparator	balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. Receives: Device: balafilcon A toric contact lens
senofilcon A/balafilcon A contralaterally	Active comparator	senofilcon A lens worn in one eye and balafilcon A lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly. Receives: Device: senofilcon A toric contact lens; Device: balafilcon A toric contact lens

What is being measured

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

Corneal Staining
Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
Measured: at 3 months of lens wear (period 1)
Limbal Redness
Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
Measured: at 3 months of lens wear (period 1)
Bulbar Redness
Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
Measured: at 3 months of lens wear (period 1)
Tarsal Roughness
Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
Measured: at 3 months of lens wear (period 1)

Timeline

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

Jun 2007Jan 2008

First posted30 Sep 2008 (estimated)
Study startJun 2007
Primary completionJan 2008
Study completionJan 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 AstigmatismStudies 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: Parallel groups
Masking: None (open label)
Enrolment: 112 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00762502
Sponsor's protocol ID: CR-4498
Status last verified: May 2015
First submitted: 26 Sep 2008
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

Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
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The EYERISING Study
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Active, not recruiting
P1 Toric Vs. Max 1day
Eye, Astigmatism
Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
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Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism

All Astigmatism 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 Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period
ClinicalTrials.gov ID: NCT00762502
Acronym / sponsor ID: CR-4498
Conditions: Astigmatism
Study type: Interventional
Recruitment status: Completed
Enrolment: 112 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: Jun 2007
Primary completion: Jan 2008 (actual)
Study completion: Jan 2008 (actual)
First posted: 30 Sep 2008 (estimated)
Results: Posted 25 Nov 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate two toric contact lenses on the ocular physiology of existing contact lens wearers when used in an extended wear modality of days/six nights.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
senofilcon A toric bilaterally	Active comparator	Device: senofilcon A toric contact lenssenofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.
balafilcon A toric bilaterally	Active comparator	Device: balafilcon A toric contact lensbalafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.
senofilcon A/balafilcon A contralaterally	Active comparator	Device: senofilcon A toric contact lens, Device: balafilcon A toric contact lenssenofilcon A lens worn in one eye and balafilcon A lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Able to wear study lenses in parameters available
Non-presbyopes between the ages of 18-45
Understand and sign informed consent
Willing to follow the protocol
Achieve at least 20/30 (6/9) visual acuity (VA) in right eye (OD) and left eye (OS) with study lenses

Key exclusion criteria (13 listed)

Any ocular or systemic disorder which may contraindicate contact lens wear
Any topical ocular medication
Aphakic
Corneal refractive surgery
Corneal distortion from hard CL wear or keratoconus

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 A toric contact lenssoft contact lens	Device	senofilcon A toric bilaterally, senofilcon A/balafilcon A contralaterally
balafilcon A toric contact lenssoft contact lens	Device	balafilcon A toric bilaterally, senofilcon A/balafilcon A contralaterally

Primary outcome

Corneal Staining
Time frame: at 3 months of lens wear (period 1)
Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
Limbal Redness
Time frame: at 3 months of lens wear (period 1)
Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
Bulbar Redness
Time frame: at 3 months of lens wear (period 1)
Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
Tarsal Roughness
Time frame: at 3 months of lens wear (period 1)
Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.

Results and safety

Results posted to the registry on 25 Nov 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 Bilaterally	36	26
Balafilcon A Bilaterally	25	19
Senofilcon A Toric/Balafilcon A Toric Contralaterally	51	32

Primary outcome: Corneal Staining

Time frame: at 3 months of lens wear (period 1). Mean (Standard Deviation). Unit: units on a scale

Measure	Senofilcon A n = 42	Balafilcon A n = 35
Value	0.6 (0.61)	0.8 (0.74)

Population analysed: Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis.

Primary outcome: Limbal Redness

Time frame: at 3 months of lens wear (period 1). Mean (Standard Deviation). Unit: units on a scale

Measure	Senofilcon A n = 42	Balafilcon A n = 35
Value	0.7 (0.61)	0.7 (0.58)

Primary outcome: Bulbar Redness

Time frame: at 3 months of lens wear (period 1). Mean (Standard Deviation). Unit: units on a scale

Measure	Senofilcon A n = 42	Balafilcon A n = 35
Value	0.9 (0.58)	0.8 (0.57)

Primary outcome: Tarsal Roughness

Time frame: at 3 months of lens wear (period 1). Mean (Standard Deviation). Unit: units on a scale

Measure	Senofilcon A n = 42	Balafilcon A n = 35
Value	1.1 (0.58)	1.0 (0.75)

Adverse events

Time frame: 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Senofilcon A	0 of 87 (0%)	13 of 87 (14.9%)	Not reported
Balafilcon A	1 of 76 (1.3%)	9 of 76 (11.8%)	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 Astigmatism

Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Not yet recruiting
The EYERISING Study
Myopia, Astigmatism
Active, not recruiting
P1 Toric Vs. Max 1day
Eye, Astigmatism
Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
Astigmatism, Myopia
Recruiting
Clareon TruPlus Study
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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.

8 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing senofilcon A toric contact lens and balafilcon A toric contact lens in people with Astigmatism, run by Johnson & Johnson Vision Care, Inc. at 8 sites in 2 countries.

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 9 inclusion and 13 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 8 sites in Australia, United States. 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 25 Nov 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 Staining (time frame: at 3 months of lens wear (period 1)). The study lists 4 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 NCT00762502.

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.