PresbyopiaNCT00724945
Comparison of Two Soft Bifocal Contact Lenses
A study testing balafilcon A and senofilcon A in people with Presbyopia, run by Johnson & Johnson Vision Care, Inc. at 6 sites in United States.
Trial summary
The purpose of the study is to compare the visual performance of two soft bifocal contact 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 and senofilcon A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2008to Aug 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 have presbyopic symptoms or be already wearing presbyopic contact lens correction.
- The subject's spherical equivalent distance refraction must be in the range of -1.00 to -6.00 or -9.00 to -10.00 in each eye.
- Refractive cylinder must be -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 OU 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 an immunosuppressive disease (e.g., HIV).
- History of diabetes
- History of binocular vision abnormality or strabismus
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Lee Rigel
East Lansing, Michigan, 48823
Dr. James Weber & Associates
Jacksonville, Florida, 32205
Ted Brink & Associates
Jacksonville, Florida, 32256
Study site
Jacksonville, Florida, 32256
Timothy R. Poling, OD
Roanoke, Virginia, 24153
Eye Associates of Winter Park
Winter Park, Florida, 32792
About this study
The purpose of the study is to compare the visual performance of two soft bifocal contact lenses.
- Conditions
- Presbyopia
- Being tested
- balafilcon A, senofilcon A
- 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 ADevice
multifocal contact lens
| Study group | Role | What they receive |
|---|---|---|
| senofilcon A / balafilcon A | Active comparator | senofilcon A multifocal lenses worn first, balafilcon A multifocal lenses worn second Receives: Device: balafilcon A; Device: senofilcon A |
| balafilcon A/senofilcon A | Active comparator | balafilcon A multifocal lenses worn first, senofilcon A multifocal lenses worn second Receives: Device: balafilcon A; Device: senofilcon A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance Visual Acuity
This outcome measures vision while subjects are looking at objects in the distance and is measures in logMARs.logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values >0.00 indicate vision poorer than ideal and values<0.0 indicate vision greater than ideal
Measured: after 1 week of wear
Near Visual Acuity
This outcome measures vision while subjects are looking at objects near to them and is measured in logMARs. logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values >0.00 indicate vision poorer than ideal and values<0.0 indicate vision greater than ideal.
Measured: after 1 week wear
Subject Vision
Subjects responded to "How would you rate the overall quality of vision with these study contact lenses" using the following scale: 1=poor, 2=fair, 3=good, 4=very good, 5=excellent.
Measured: after 1 week wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionAug 2008
- Study completionAug 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
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724945
- Sponsor's protocol ID
- CR-1485CK
- Status last verified
- May 2015
- First submitted
- 25 Jul 2008
- Last updated
- 21 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
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
- Comparison of Two Soft Bifocal Contact Lenses
- ClinicalTrials.gov ID
- NCT00724945
- Acronym / sponsor ID
- CR-1485CK
- Conditions
- Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 30 Jul 2008 (estimated)
- Results
- Posted 27 Jan 2010
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 compare the visual performance of two soft bifocal contact lenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| senofilcon A / balafilcon A | Active comparator | Device: balafilcon A, Device: senofilcon Asenofilcon A multifocal lenses worn first, balafilcon A multifocal lenses worn second |
| balafilcon A/senofilcon A | Active comparator | Device: balafilcon A, Device: senofilcon Abalafilcon A multifocal lenses worn first, senofilcon A multifocal lenses worn second |
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 have presbyopic symptoms or be already wearing presbyopic contact lens correction.
- The subject's spherical equivalent distance refraction must be in the range of -1.00 to -6.00 or -9.00 to -10.00 in each eye.
- Refractive cylinder must be -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 (10 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, senofilcon A / balafilcon A |
| senofilcon Amultifocal contact lens | Device | balafilcon A/senofilcon A, senofilcon A / balafilcon A |
Primary outcome
Distance Visual Acuity
Time frame: after 1 week of wear
This outcome measures vision while subjects are looking at objects in the distance and is measures in logMARs.logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values >0.00 indicate vision poorer than ideal and values<0.0 indicate vision greater than ideal
Near Visual Acuity
Time frame: after 1 week wear
This outcome measures vision while subjects are looking at objects near to them and is measured in logMARs. logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values >0.00 indicate vision poorer than ideal and values<0.0 indicate vision greater than ideal.
Subject Vision
Time frame: after 1 week wear
Subjects responded to "How would you rate the overall quality of vision with these study contact lenses" using the following scale: 1=poor, 2=fair, 3=good, 4=very good, 5=excellent.
Results and safety
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.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing balafilcon A and senofilcon A in people with Presbyopia, run by Johnson & Johnson Vision Care, Inc. at 6 sites 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 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 21 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 6 sites 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 27 Jan 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 Visual Acuity (time frame: after 1 week of wear). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.