PresbyopiaNCT00909792
Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products
A study testing Lotrafilcon B and Senofilcon A in people with Presbyopia, run by CIBA VISION.
Trial summary
The objective of this trial is compare the visual performance, ratings, and preference of two multifocal, soft contact lenses. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Presbyopia
- What is being tested?
- Lotrafilcon B and Senofilcon A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 259 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Jun 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 35 years of age
- Best-corrected distance visual acuity of at least 20/40 in each eye.
- Spectacle add between +0.75D and +1.50D (inclusive).
- Able to be fit in available study sphere powers (-1.00 to -5.00D)
- Currently wearing soft contact lenses at least 5 days a week.
- Other protocol inclusion/exclusion criteria may apply.
Who cannot join
- Eye injury or surgery within twelve weeks immediately prior to enrollment.
- Currently enrolled in an ophthalmic clinical trial.
- Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
- Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
- Astigmatism ≥ 1.00D.
- Currently wearing either of the study products.
- Other protocol inclusion/exclusion criteria may apply.
About this study
The objective of this trial is compare the visual performance, ratings, and preference of two multifocal, soft contact lenses.
- Conditions
- Presbyopia
- Being tested
- Lotrafilcon B, 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.
Lotrafilcon BDevice
Silicone hydrogel, soft, multifocal contact lens
Senofilcon ADevice
Silicone hydrogel, soft, multifocal contact lens
| Study group | Role | What they receive |
|---|---|---|
| Lotrafilcon B / Senofilcon A | Other | Lotrafilcon B, followed by Senofilcon A Receives: Device: Lotrafilcon B; Device: Senofilcon A |
| Senofilcon A / Lotrafilcon B | Other | Senofilcon A, followed by Lotrafilcon B Receives: Device: Lotrafilcon B; Device: Senofilcon A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity
Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.
Measured: After 1 week of wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2009
- Study completionJun 2009
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
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- CIBA VISION
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00909792
- Sponsor's protocol ID
- P-319-C-013
- Status last verified
- Jan 2012
- First submitted
- 27 May 2009
- Last updated
- 29 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products
- ClinicalTrials.gov ID
- NCT00909792
- Acronym / sponsor ID
- P-319-C-013
- Conditions
- Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- CIBA VISIONIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 28 May 2009 (estimated)
- Results
- Posted 29 Oct 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this trial is compare the visual performance, ratings, and preference of two multifocal, soft contact lenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lotrafilcon B / Senofilcon A | Other | Device: Lotrafilcon B, Device: Senofilcon ALotrafilcon B, followed by Senofilcon A |
| Senofilcon A / Lotrafilcon B | Other | Device: Lotrafilcon B, Device: Senofilcon ASenofilcon A, followed by Lotrafilcon B |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be at least 35 years of age
- Best-corrected distance visual acuity of at least 20/40 in each eye.
- Spectacle add between +0.75D and +1.50D (inclusive).
- Able to be fit in available study sphere powers (-1.00 to -5.00D)
- Currently wearing soft contact lenses at least 5 days a week.
Key exclusion criteria (7 listed)
- Eye injury or surgery within twelve weeks immediately prior to enrollment.
- Currently enrolled in an ophthalmic clinical trial.
- Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
- Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
- Astigmatism ≥ 1.00D.
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 |
|---|---|---|
| Lotrafilcon BSilicone hydrogel, soft, multifocal contact lens | Device | Lotrafilcon B / Senofilcon A, Senofilcon A / Lotrafilcon B |
| Senofilcon ASilicone hydrogel, soft, multifocal contact lens | Device | Lotrafilcon B / Senofilcon A, Senofilcon A / Lotrafilcon B |
Primary outcome
Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity
Time frame: After 1 week of wear
Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2012.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Lotrafilcon B and Senofilcon A in people with Presbyopia, run by CIBA VISION.
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 6 inclusion and 7 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 29 Jun 2012. 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 29 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?
Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity (time frame: After 1 week of wear). 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 29 Jun 2012.