PresbyopiaNCT00808340

Comparison of Three Soft Bifocal Contact Lenses

A study testing balafilcon A, senofilcon A production and senofilcon A test in people with Presbyopia, run by Johnson & Johnson Vision Care, Inc. at 1 site in United States.

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 primary purpose of the study is to compare the performance of three soft bifocal contact lenses in terms of the vision provided by the lenses. Read more about this study

Who is it for?: Ages 35 to 70 years
Conditions the study is for: Presbyopia
What is being tested?: balafilcon A, senofilcon A production and senofilcon A test
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2008to 1 Dec 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 35 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The subject must between 35 and 70 years of age.
The subject must respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire" or be already wearing presbyopic contact lens correction ( e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses etc.).
The subject's spherical equivalent distance refraction must be in the range of -1.00 to -6.00 in each eye.
Refractive cylinder must be less than or equal to -0.75 D in each eye.
The subject must have an add power of +0.75D to +2.50D in each eye.
The subject must have best corrected visual acuity of 20/20-3 or better in each eye.

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The subject's must have at least 20/30-distance vision with the study contact lenses.
The subject must agree that they are comfortable with their vision prior to being dispensed the study lenses.
The subject must be an adapted soft contact lens wearer in both eyes.
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form.

Who cannot join

Ocular or systemic allergies or disease that may interfere with contact lens wear.
Systemic disease, autoimmune disease or use of medication, which may interfere with contact lens wear.
Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear.
Clinically significant (grade 3 or 4) tarsal abnormalities that might interfere with contact lens wear.
Any ocular infection.
Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

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Pregnancy or lactation
Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV).
History of diabetes. History of binocular vision abnormality or strabismus.

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Roanoke, Virginia, 24153

Other trials in United States

About this study

The primary purpose of the study is to compare the performance of three soft bifocal contact lenses in terms of the vision provided by the lenses.

Conditions: Presbyopia
Being tested: balafilcon A, senofilcon A production, senofilcon A test
Medical subject headings: Presbyopia

What participants receive

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

balafilcon ADevice
multifocal contact lens
senofilcon A productionDevice
multifocal contact lens
senofilcon A testDevice
multifocal contact lens

Study groups in NCT00808340
Study group	Role	What they receive
senofilA test/senofilA prod/balafilconA	Active comparator	Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, senofilcon A production worn second, and balafilcon A worn third. Receives: Device: balafilcon A; Device: senofilcon A production; Device: senofilcon A test
senofilcon A test/balafilcon A/senofilcon A prod	Active comparator	Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, balafilcon A worn second, and senofilcon A production worn third. Receives: Device: balafilcon A; Device: senofilcon A production; Device: senofilcon A test
senofilcon A prod/senofilcon A test/balafilcon A	Active comparator	Subjects wear 3 multifocal contact lenses: senofilcon A production worn first, senofilcon A test worn second, and balafilcon A worn third. Receives: Device: balafilcon A; Device: senofilcon A production; Device: senofilcon A test
senofilcon A prod/ balifilcon A/ senofilcon A test	Active comparator	Subjects wear 3 multifocal contact lenses: senofilcon A production worn first, balafilcon A worn second, and senofilcon A test worn third. Receives: Device: balafilcon A; Device: senofilcon A production; Device: senofilcon A test
balafilcon A/senofilcon A test/senofilcon A prod	Active comparator	Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A test worn second, and senofilcon A production worn third. Receives: Device: balafilcon A; Device: senofilcon A production; Device: senofilcon A test
balafilcon A/senofilcon A prod/senofilcon A test	Active comparator	Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A production worn second, senofilcon A test worn third. Receives: Device: balafilcon A; Device: senofilcon A production; Device: senofilcon A test

What is being measured

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

Distance Bright Illumination Binocular Visual Performance Reported as Visual Acuity
Tested with both eyes together in bright lighting, reading charts distant to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Measured: 5 minutes after insertion
Near Bright Illumination Binocular Visual Performance Reported as Visual Acuity
Tested with both eyes together in bright lighting reading charts near to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Measured: 5 minutes after insertion
Type of Corneal Staining
Investigator rated type of corneal staining as either 0=none, 1=micropunctate, 2=macropunctate, 3=coalesced, or 4=patch(> or = to mm).
Measured: after 1 week of lens wear, for each lens type
Overall Subjective Vision
Subject rated the overall quality of vision with the study contact lenses. 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
Measured: after 1 week of lens wear, for each lens type

Timeline

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

1 Nov 20081 Dec 2008

First posted15 Dec 2008 (estimated)
Study start1 Nov 2008
Primary completion1 Dec 2008
Study completion1 Dec 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 PresbyopiaStudies 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: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00808340
Sponsor's protocol ID: CR-1485FA
Status last verified: Aug 2017
First submitted: 12 Dec 2008
Last updated: 19 Jun 2018
Results posted: Yes, on ClinicalTrials.gov

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

Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
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Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
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Recruiting
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All Presbyopia 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 Three Soft Bifocal Contact Lenses
ClinicalTrials.gov ID: NCT00808340
Acronym / sponsor ID: CR-1485FA
Conditions: Presbyopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 1 Nov 2008 (actual)
Primary completion: 1 Dec 2008 (actual)
Study completion: 1 Dec 2008 (actual)
First posted: 15 Dec 2008 (estimated)
Results: Posted 26 Aug 2010

Clinical summary

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

The primary purpose of the study is to compare the performance of three soft bifocal contact lenses in terms of the vision provided by the lenses.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 6

Arm	Type	Receives
senofilA test/senofilA prod/balafilconA	Active comparator	Device: balafilcon A, Device: senofilcon A production, Device: senofilcon A testSubjects wear 3 multifocal contact lenses: senofilcon A test worn first, senofilcon A production worn second, and balafilcon A worn third.
senofilcon A test/balafilcon A/senofilcon A prod	Active comparator	Device: balafilcon A, Device: senofilcon A production, Device: senofilcon A testSubjects wear 3 multifocal contact lenses: senofilcon A test worn first, balafilcon A worn second, and senofilcon A production worn third.
senofilcon A prod/senofilcon A test/balafilcon A	Active comparator	Device: balafilcon A, Device: senofilcon A production, Device: senofilcon A testSubjects wear 3 multifocal contact lenses: senofilcon A production worn first, senofilcon A test worn second, and balafilcon A worn third.
senofilcon A prod/ balifilcon A/ senofilcon A test	Active comparator	Device: balafilcon A, Device: senofilcon A production, Device: senofilcon A testSubjects wear 3 multifocal contact lenses: senofilcon A production worn first, balafilcon A worn second, and senofilcon A test worn third.
balafilcon A/senofilcon A test/senofilcon A prod	Active comparator	Device: balafilcon A, Device: senofilcon A production, Device: senofilcon A testSubjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A test worn second, and senofilcon A production worn third.
balafilcon A/senofilcon A prod/senofilcon A test	Active comparator	Device: balafilcon A, Device: senofilcon A production, Device: senofilcon A testSubjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A production worn second, senofilcon A test worn third.

Who may qualify

Ages: 35 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

The subject must between 35 and 70 years of age.
The subject must respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire" or be already wearing presbyopic contact lens correction ( e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses etc.).
The subject's spherical equivalent distance refraction must be in the range of -1.00 to -6.00 in each eye.
Refractive cylinder must be less than or equal to -0.75 D in each eye.
The subject must have an add power of +0.75D to +2.50D in each eye.

Key exclusion criteria (9 listed)

Ocular or systemic allergies or disease that may interfere with contact lens wear.
Systemic disease, autoimmune disease or use of medication, which may interfere with contact lens wear.
Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear.
Clinically significant (grade 3 or 4) tarsal abnormalities that might interfere with contact lens wear.
Any ocular infection.

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
balafilcon Amultifocal contact lens	Device	balafilcon A/senofilcon A prod/senofilcon A test, balafilcon A/senofilcon A test/senofilcon A prod, senofilA test/senofilA prod/balafilconA, senofilcon A prod/ balifilcon A/ senofilcon A test, senofilcon A prod/senofilcon A test/balafilcon A, senofilcon A test/balafilcon A/senofilcon A prod
senofilcon A productionmultifocal contact lens	Device	balafilcon A/senofilcon A prod/senofilcon A test, balafilcon A/senofilcon A test/senofilcon A prod, senofilA test/senofilA prod/balafilconA, senofilcon A prod/ balifilcon A/ senofilcon A test, senofilcon A prod/senofilcon A test/balafilcon A, senofilcon A test/balafilcon A/senofilcon A prod
senofilcon A testmultifocal contact lens	Device	balafilcon A/senofilcon A prod/senofilcon A test, balafilcon A/senofilcon A test/senofilcon A prod, senofilA test/senofilA prod/balafilconA, senofilcon A prod/ balifilcon A/ senofilcon A test, senofilcon A prod/senofilcon A test/balafilcon A, senofilcon A test/balafilcon A/senofilcon A prod

Primary outcome

Distance Bright Illumination Binocular Visual Performance Reported as Visual Acuity
Time frame: 5 minutes after insertion
Tested with both eyes together in bright lighting, reading charts distant to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Near Bright Illumination Binocular Visual Performance Reported as Visual Acuity
Time frame: 5 minutes after insertion
Tested with both eyes together in bright lighting reading charts near to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Type of Corneal Staining
Time frame: after 1 week of lens wear, for each lens type
Investigator rated type of corneal staining as either 0=none, 1=micropunctate, 2=macropunctate, 3=coalesced, or 4=patch(> or = to mm).
Overall Subjective Vision
Time frame: after 1 week of lens wear, for each lens type
Subject rated the overall quality of vision with the study contact lenses. 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.

Results and safety

Results posted to the registry on 26 Aug 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 Test/Senofilcon A Prod/Balafilcon A	4	4
Senofilcon A Test/Balafilcon A/Senofilcon A Prod	9	9
Senofilcon A Prod/Senofilcon A Test/Balafilcon A	7	7
Senofilcon A Prod/ Balifilcon A/ Senofilcon A Test	3	3
Balafilcon A/Senofilcon A Test/Senofilcon A Prod	5	5
Balafilcon A/Senofilcon A Prod/Senofilcon A Test	6	6

Primary outcome: Distance Bright Illumination Binocular Visual Performance Reported as Visual Acuity

Time frame: 5 minutes after insertion. Least squares mean (Standard Error). Unit: logMAR

Measure	Senofilcon A Test n = 34	Senofilcon A Prod n = 34	Balafilcon A n = 34
Value	0.8191 (0.161)	0.6942 (0.161)	1.0635 (0.161)

Senofilcon A Test vs Senofilcon A Prod: Mean Difference (Final Values): -0.1249 (97.5% CI -0.4143 to 0.1644), Mixed Models Analysis
Senofilcon A Prod vs Balafilcon A: Mean Difference (Final Values): -0.3693 (97.5% CI -0.6587 to -0.07996), Mixed Models Analysis

Primary outcome: Near Bright Illumination Binocular Visual Performance Reported as Visual Acuity

Time frame: 5 minutes after insertion. Least squares mean (Standard Error). Unit: logMAR

Measure	Senofilcon A Test n = 34	Senofilcon A Prod n = 34	Balafilcon A n = 34
Value	-0.6735 (0.161)	-0.6327 (0.161)	-0.1719 (0.161)

Senofilcon A Test vs Senofilcon A Prod: Mean Difference (Final Values): -0.04083 (97.5% CI -0.2485 to 0.3302), Mixed Models Analysis
Senofilcon A Prod vs Balafilcon A: Mean Difference (Final Values): -0.4608 (97.5% CI -0.7502 to -0.1714), Mixed Models Analysis

Primary outcome: Type of Corneal Staining

Time frame: after 1 week of lens wear, for each lens type. Least squares mean (Standard Error). Unit: Units on a scale

Measure	Senofilcon A Test n = 34	Senofilcon A Prod n = 34	Balafilcon A n = 34
Value	0.1311 (0.07154)	0.1017 (0.07154)	0.1694 (0.07154)

Senofilcon A Test vs Senofilcon A Prod: Mean Difference (Final Values): -0.02941 (97.5% CI -0.08153 to 0.02271), Mixed Models Analysis
Senofilcon A Prod vs Balafilcon A: Mean Difference (Final Values): -0.06765 (97.5% CI -0.1198 to -0.01553), Mixed Models Analysis

Primary outcome: Overall Subjective Vision

Time frame: after 1 week of lens wear, for each lens type. Least squares mean (Standard Error). Unit: Units on a scale

Measure	Senofilcon A Test n = 34	Senofilcon A Prod n = 34	Balafilcon A n = 34
Value	3.5373 (0.1681)	3.207 (0.1681)	3.4351 (0.1681)

Senofilcon A Test vs Senofilcon A Prod: Mean Difference (Final Values): -0.3304 (97.5% CI -0.779 to 0.1183), Mixed Models Analysis
Senofilcon A Prod vs Balafilcon A: Mean Difference (Final Values): -0.2281 (97.5% CI -0.6767 to 0.2206), Mixed Models Analysis

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Senofilcon A Test	0 of 34 (0%)	0 of 34 (0%)	Not reported
Senofilcon A Prod	0 of 34 (0%)	0 of 34 (0%)	Not reported
Balafilcon A	0 of 34 (0%)	0 of 34 (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.

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

Questions about this trial

What is this clinical trial studying?

A study testing balafilcon A, senofilcon A production and senofilcon A test in people with Presbyopia, run by Johnson & Johnson Vision Care, Inc. at 1 site in United States.

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 11 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 1 site in 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 26 Aug 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?

Distance Bright Illumination Binocular Visual Performance Reported as Visual Acuity (time frame: 5 minutes after insertion). 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 NCT00808340.

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.