AstigmatismNCT00584220

Evaluation of Two Toric Soft Contact Lenses After Two Weeks of Wear

A study testing senofilcon A toric and alphafilcon A toric in people with Astigmatism, run by Johnson & Johnson Vision Care, Inc..

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 determine the relative performance of a new toric soft contact lens against a toric contact lens currently available in market, specifically with regards to the comfort and vision after two weeks of use. Read more about this study

Who is it for?: Ages 18 to 39 years
Conditions the study is for: Astigmatism
What is being tested?: senofilcon A toric and alphafilcon A toric
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 96 participants
Where: No sites listed yet
Study dates: Sep 2007to Dec 2007
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

None listed.

Who cannot join

The subject is a rigid gas permeable (RGP) or daily disposable soft lens wearer.
The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjögren's syndrome, type II diabetes, etc).
Slit lamp findings that would contraindicate contact lens wear such as:
Pathological dry eye or associated findings
Pterygium or corneal scars within the visual axis

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Neovascularization >1mm in from the limbus
History of giant papillary conjunctivitis (GPC) worse than Grade 2
Anterior uveitis or iritis (past or present)
Seborrhoeic eczema, seborrhoeic conjunctivitis
A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections.
A known history of corneal hypoesthesia (reduced corneal sensitivity.)
Aphakia, keratoconus or a highly irregular cornea.
Current pregnancy or lactation (to the best of the subject's knowledge).
Active participation in another clinical study at any time during this study.

About this study

Official title: Evaluation of Fit and Visual Acuity of the Investigational Toric Lens in Two Phases: Part B: A Dispensing Cross-over Comparison to SofLens66 Toric

Read the detailed description

Dispensing, single-masked (subject-masked), randomized, 2-visit controlled study of two-weeks duration.

Conditions: Astigmatism
Being tested: senofilcon A toric, alphafilcon A toric
Keywords: Astigmatism, vision, comfort, satisfaction, contact lenses
Medical subject headings: Astigmatism, Personal Satisfaction

What participants receive

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

senofilcon A toricDevice
contact lens
alphafilcon A toricDevice
Also called SofLens66 Toric
contact lens

Study groups in NCT00584220
Study group	Role	What they receive
senofilcon A toric / alphafilcon A toric	Other	senofilcon A toric contact lenses worn daily during the first period, then alphafilcon A toric contact lenses worn daily during the second period Receives: Device: senofilcon A toric; Device: alphafilcon A toric
alphafilcon A toric / senofilcon A toric	Other	alphafilcon A toric contact lenses worn daily during the first period, then senofilcon A toric contact lenses worn daily during the second period Receives: Device: senofilcon A toric; Device: alphafilcon A toric

What is being measured

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

Subjective Reported Vision
A weighted combined score of one week and two week data calculated from individual vision-related questions asked on a 1-5 scale, 1 = most negative response to 5 = most positive, was used to derive vision outcomes. The analysis shows the outcome for both senofilcon A and alphafilcon A. If score >0 then greater vision, if <0 then lesser vision.
Measured: 1 week
Subject Reported Lens Comfort.
A weighted combined score of one week and two week data calculated from individual comfort-related questions asked on a 1-5 scale, 1=most negative response to 5=most positive response, was used to derive comfort outcomes. The analysis shows the estimates for senofilcon A and alphafilcon A, respectively. Interpretation is >0 indicates comfortable and <0 indicates uncomfortable.
Measured: 1 week

Timeline

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

Sep 2007Dec 2007

First posted2 Jan 2008 (estimated)
Study startSep 2007
Primary completionDec 2007
Study completionDec 2007

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: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00584220
Sponsor's protocol ID: CR-0714B
Status last verified: May 2015
First submitted: 20 Dec 2007
Last updated: 21 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?

Official record

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
Aphakia, Astigmatism

All Astigmatism trials

Study at a glance

From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Fit and Visual Acuity of the Investigational Toric Lens in Two Phases: Part B: A Dispensing Cross-over Comparison to SofLens66 Toric
ClinicalTrials.gov ID: NCT00584220
Acronym / sponsor ID: CR-0714B
Conditions: Astigmatism
Keywords: Astigmatism, vision, comfort, satisfaction, contact lenses
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Collaborators: Foresight Regulatory Strategies, Inc.
Study start: Sep 2007
Primary completion: Dec 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 2 Jan 2008 (estimated)
Results: Posted 19 Feb 2010

Clinical summary

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

Detailed description

Dispensing, single-masked (subject-masked), randomized, 2-visit controlled study of two-weeks duration.

Study design

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

Arm	Type	Receives
senofilcon A toric / alphafilcon A toric	Other	Device: senofilcon A toric, Device: alphafilcon A toricsenofilcon A toric contact lenses worn daily during the first period, then alphafilcon A toric contact lenses worn daily during the second period
alphafilcon A toric / senofilcon A toric	Other	Device: senofilcon A toric, Device: alphafilcon A toricalphafilcon A toric contact lenses worn daily during the first period, then senofilcon A toric contact lenses worn daily during the second period

Who may qualify

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

Key inclusion criteria (0 listed)

Key exclusion criteria (15 listed)

The subject is a rigid gas permeable (RGP) or daily disposable soft lens wearer.
The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjögren's syndrome, type II diabetes, etc).
Slit lamp findings that would contraindicate contact lens wear such as:
A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections.

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 toriccontact lens	Device	alphafilcon A toric / senofilcon A toric, senofilcon A toric / alphafilcon A toric
alphafilcon A toricAlso: SofLens66 Toriccontact lens	Device	alphafilcon A toric / senofilcon A toric, senofilcon A toric / alphafilcon A toric

Primary outcome

Subjective Reported Vision
Time frame: 1 week
A weighted combined score of one week and two week data calculated from individual vision-related questions asked on a 1-5 scale, 1 = most negative response to 5 = most positive, was used to derive vision outcomes. The analysis shows the outcome for both senofilcon A and alphafilcon A. If score >0 then greater vision, if <0 then lesser vision.
Subject Reported Lens Comfort.
Time frame: 1 week
A weighted combined score of one week and two week data calculated from individual comfort-related questions asked on a 1-5 scale, 1=most negative response to 5=most positive response, was used to derive comfort outcomes. The analysis shows the estimates for senofilcon A and alphafilcon A, respectively. Interpretation is >0 indicates comfortable and <0 indicates uncomfortable.

Results and safety

Results posted to the registry on 19 Feb 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 / Alphafilcon A	48	48
Alphafilcon A / Senofilcon A	39	39

Primary outcome: Subjective Reported Vision

Time frame: 1 week. Least squares mean (Standard Deviation). Unit: Units on a scale

Measure	Senofilcon A Toric n = 87	Alphafilcon A Toric n = 87
Value	0.33 (0.795)	-0.17 (0.788)

Population analysed: Analysis includes only participants who completed the study per protocol and had no missing data.

Primary outcome: Subject Reported Lens Comfort.

Time frame: 1 week. Least squares mean (Standard Deviation). Unit: Units on a scale

Measure	Senofilcon A Toric n = 87	Alphafilcon A Toric n = 87
Value	0.37 (0.730)	-0.38 (0.723)

Population analysed: Analysis includes only participants who completed the study per protocol and had no missing data.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Senofilcon A	0 of 96 (0%)	0 of 96 (0%)	Not reported
Alphafilcon A	0 of 96 (0%)	0 of 96 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
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
Aphakia, Astigmatism

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.

Jason Chin, O.D. principal investigator

James Fujimoto, O.D. principal investigator

Weslie Hamada, O.D. principal investigator

Arthur T. Kobayashi, O.D., Inc.

Questions about this trial

What is this clinical trial studying?

A study testing senofilcon A toric and alphafilcon A toric in people with Astigmatism, run by Johnson & Johnson Vision Care, Inc..

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 0 inclusion and 15 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 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.

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 19 Feb 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?

Subjective Reported Vision (time frame: 1 week). The study lists 2 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 NCT00584220.

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 21 May 2015.