AstigmatismNCT00697190

Clinical Performance of Atypical Contact Lens Powers on Subjects With Astigmatism

A study testing senofilcon A toric and galyfilcon A toric in people with Astigmatism, run by Johnson & Johnson Vision Care, Inc. at 1 site 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

This study will evaluate the fitting characteristics and physiological response of two toric lenses manufactured by Vistakon. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Astigmatism
What is being tested?: senofilcon A toric and galyfilcon A toric
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 1 siteUnited Kingdom
Study dates: May 2008to Sep 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Able to wear study lenses in parameters available.
At least 18
understand and sign informed consent
willing to follow the protocol
achieve at least 6/9 Visual Acuity (VA), both eyes (OU) with study lenses
hyperopes: +2.00 to +4.00 with -0.75 D cylinder around 180, high myopes: -6.00 to -8.00 with -1.25 D cylinder around 180
oblique axis: -2.00 to -4.00 with -0.75 D cyl around 45 or 135, have worn Soft Contact Lenses's within last 6 months

Who cannot join

Any ocular or systemic disorder which may contraindicate Contact Lens (CL) wear
any topical ocular medication
aphakic
corneal refractive surgery,
corneal distortion from hard CL wear or keratoconus
pregnant or lactating

Show all 10Show fewer

grade 2 or worse slit lamp signs
infectious disease
previous clinical study within 2 weeks
don't agree to participate

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Eurolens Research
Manchester

Other trials in United Kingdom

About this study

This study will evaluate the fitting characteristics and physiological response of two toric lenses manufactured by Vistakon.

Conditions: Astigmatism
Being tested: senofilcon A toric, galyfilcon A toric
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 toricDevice
Also called Acuvue Oasys for Astigmatism
silicone hydrogel contact lens for patients with astigmatism
galyfilcon A toricDevice
Also called Acuvue Advance for Astigmatism
silicone hydrogel contact lens for patients with astigmatism

Study groups in NCT00697190
Study group	Role	What they receive
senofilcon A/galyfilcon A	Active comparator	senofilcon A silicone hydrogel toric contact lenses will be worn first. galyfilcon A silicone hydrogel toric contact lenses will be worn second. Receives: Device: senofilcon A toric; Device: galyfilcon A toric
galyfilcon A/senofilcon A	Active comparator	galyfilcon A silicone hydrogel toric contact lenses worn first. senofilcon A silicone hydrogel toric contact lenses worn second. Receives: Device: senofilcon A toric; Device: galyfilcon A toric

What is being measured

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

Assessment of Conjunctival Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Measured: after 6 hours of wear
Assessment of Conjunctival Hyperemia in Subjects That Are Hyperopes (Farsighted)
Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Measured: after 6 hours of wear
Assessment of Conjunctival Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Measured: after 6 hours of wear
Assessment of Limbal Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Measured: after 6 hours of wear
Assessment of Limbal Hyperemia in Subjects That Are Hyperopes (Farsighted)
Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Measured: after 6 hours of wear
Assessment of Limbal Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Measured: after 6 hours of wear
Assessment of Corneal Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Measured: after 6 hours of wear
Assessment of Corneal Staining in Subjects That Are Hyperopes (Farsighted)
Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Measured: after 6 hours of wear
Assessment of Corneal Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Measured: after 6 hours of wear
Assessment of Conjunctival Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Measured: after 6 hours of wear
Assessment of Conjunctival Staining in Subjects That Are Hyperopes (Farsighted)
Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Measured: after 6 hours of wear
Assessment of Conjunctival Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Measured: after 6 hours of wear
Assessment of Papillary Conjunctivitis in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Measured: after 6 hours of wear
Assessment of Papillary Conjunctivitis in Subjects That Are Hyperopes (Farsighted)
Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Measured: after 6 hours of wear
Assessment of Papillary Conjunctivitis in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Measured: after 6 hours of wear

Timeline

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

May 2008Sep 2008

First posted13 Jun 2008 (estimated)
Study startMay 2008
Primary completionSep 2008
Study completionSep 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00697190
Sponsor's protocol ID: CR-4523
Status last verified: May 2015
First submitted: 10 Jun 2008
Last updated: 22 May 2015
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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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
Aphakia, Astigmatism

All Astigmatism trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Performance of Atypical Contact Lens Powers on Subjects With Astigmatism
ClinicalTrials.gov ID: NCT00697190
Acronym / sponsor ID: CR-4523
Conditions: Astigmatism
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: May 2008
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 13 Jun 2008 (estimated)
Results: Posted 1 Oct 2010

Clinical summary

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

This study will evaluate the fitting characteristics and physiological response of two toric lenses manufactured by Vistakon.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
senofilcon A/galyfilcon A	Active comparator	Device: senofilcon A toric, Device: galyfilcon A toricsenofilcon A silicone hydrogel toric contact lenses will be worn first. galyfilcon A silicone hydrogel toric contact lenses will be worn second.
galyfilcon A/senofilcon A	Active comparator	Device: senofilcon A toric, Device: galyfilcon A toricgalyfilcon A silicone hydrogel toric contact lenses worn first. senofilcon A silicone hydrogel toric contact lenses worn second.

Who may qualify

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

Key inclusion criteria (7 listed)

Able to wear study lenses in parameters available.
At least 18
understand and sign informed consent
willing to follow the protocol
achieve at least 6/9 Visual Acuity (VA), both eyes (OU) with study lenses

Key exclusion criteria (10 listed)

Any ocular or systemic disorder which may contraindicate Contact Lens (CL) 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 toricAlso: Acuvue Oasys for Astigmatismsilicone hydrogel contact lens for patients with astigmatism	Device	galyfilcon A/senofilcon A, senofilcon A/galyfilcon A
galyfilcon A toricAlso: Acuvue Advance for Astigmatismsilicone hydrogel contact lens for patients with astigmatism	Device	galyfilcon A/senofilcon A, senofilcon A/galyfilcon A

Primary outcome

Assessment of Conjunctival Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
Time frame: after 6 hours of wear
Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Conjunctival Hyperemia in Subjects That Are Hyperopes (Farsighted)
Time frame: after 6 hours of wear
Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Conjunctival Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
Time frame: after 6 hours of wear
Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Limbal Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
Time frame: after 6 hours of wear
Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Limbal Hyperemia in Subjects That Are Hyperopes (Farsighted)
Time frame: after 6 hours of wear
Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Limbal Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
Time frame: after 6 hours of wear
Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Corneal Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
Time frame: after 6 hours of wear
Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Corneal Staining in Subjects That Are Hyperopes (Farsighted)
Time frame: after 6 hours of wear
Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Corneal Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
Time frame: after 6 hours of wear
Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Conjunctival Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
Time frame: after 6 hours of wear
Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Conjunctival Staining in Subjects That Are Hyperopes (Farsighted)
Time frame: after 6 hours of wear
Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Conjunctival Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
Time frame: after 6 hours of wear
Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Papillary Conjunctivitis in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
Time frame: after 6 hours of wear
Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Papillary Conjunctivitis in Subjects That Are Hyperopes (Farsighted)
Time frame: after 6 hours of wear
Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Papillary Conjunctivitis in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
Time frame: after 6 hours of wear
Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

Results and safety

Results posted to the registry on 1 Oct 2010, 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/Galyfilcon A	19	19
Galyfilcon A/Senofilcon A	20	20

Primary outcome: Assessment of Conjunctival Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)

Time frame: after 6 hours of wear. Least squares mean (Standard Error). Unit: Units on a scale

Measure	Senofilcon A n = 11	Galyfilcon A n = 11
Value	1.10 (0.05)	1.23 (0.05)

Senofilcon A vs Galyfilcon A: Mean Difference (Final Values): -0.13 (97.5% CI -0.29 to 0.04), Mixed Models Analysis

Population analysed: There were 11 subjects that were high myopes within the total completed population of 38.

Primary outcome: Assessment of Conjunctival Hyperemia in Subjects That Are Hyperopes (Farsighted)

Time frame: after 6 hours of wear. Least squares mean (Standard Error). Unit: Units on a scale

Measure	Senofilcon A n = 14	Galyfilcon A n = 14
Value	1.16 (0.07)	1.18 (0.05)

Senofilcon A vs Galyfilcon A: Mean Difference (Final Values): -0.02 (97.5% CI -0.10 to 0.06), Mixed Models Analysis

Population analysed: There were 14 subjects that were hyperopes within the total completed population of 38.

Primary outcome: Assessment of Conjunctival Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)

Time frame: after 6 hours of wear. Least squares mean (Standard Error). Unit: Units on a scale

Measure	Senofilcon A n = 13	Galyfilcon A n = 13
Value	1.08 (0.07)	1.14 (0.08)

Senofilcon A vs Galyfilcon A: Mean Difference (Final Values): -0.07 (97.5% CI -0.23 to 0.10), Mixed Models Analysis

Population analysed: There were 13 subjects that were oblique astigmats within the total completed population of 38.

Primary outcome: Assessment of Limbal Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)

Time frame: after 6 hours of wear. Least squares mean (Standard Error). Unit: Units on a scale

Measure	Senofilcon A n = 11	Galyfilcon A n = 11
Value	0.97 (0.05)	1.07 (0.07)

Senofilcon A vs Galyfilcon A: Mean Difference (Final Values): -0.11 (97.5% CI -0.25 to 0.04), Mixed Models Analysis

Population analysed: There were 11 subjects that were high myopes within the total completed population of 38.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Senofilcon A	0 of 19 (0%)	1 of 19 (5.3%)	Not reported
Galyfilcon A	0 of 20 (0%)	2 of 20 (10%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Astigmatism

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The EYERISING 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.

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

Questions about this trial

What is this clinical trial studying?

A study testing senofilcon A toric and galyfilcon A toric in people with Astigmatism, run by Johnson & Johnson Vision Care, Inc. at 1 site 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 7 inclusion and 10 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 22 May 2015. 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 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 1 Oct 2010). 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?

Assessment of Conjunctival Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) (time frame: after 6 hours of wear). The study lists 15 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 NCT00697190.

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 22 May 2015.