PresbyopiaNCT01268501
Clinical Assessment of a Multifocal Contact Lens for People Who Use Reading Glasses Only
A study testing Lotrafilcon B multifocal contact lens in people with Presbyopia, run by CIBA VISION.
Trial summary
The purpose of this trial is to evaluate the use of multifocal contact lenses in people who use reading glasses only. Read more about this study
- Who is it for?
- Ages 40 to 48 years
- Conditions the study is for
- Presbyopia
- What is being tested?
- Lotrafilcon B multifocal contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Feb 2011
- 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 40 to 48 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Is between 40 and 48 years of age (inclusive).
- Has read and signed the Informed Consent.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Wears reading spectacles for close work.
- Other protocol-defined inclusion/exclusion criteria may apply.
Who cannot join
- Eye injury or surgery within twelve weeks of enrollment.
- Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions.
- Currently enrolled in a clinical trial.
- Has worn contact lenses previously.
- Other protocol-defined inclusion/exclusion criteria may apply.
About this study
Official title: Clinical Assessment of a New Multifocal Contact Lens With Emmetropic Presbyopes
The purpose of this trial is to evaluate the use of multifocal contact lenses in people who use reading glasses only.
- Conditions
- Presbyopia
- Being tested
- Lotrafilcon B multifocal contact lens
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lotrafilcon B multifocal contact lensDevice
Also called AIR OPTIX® AQUA MULTIFOCAL
Commercially marketed, silicone hydrogel, multifocal, soft contact lenses FDA-approved for up to 4 weeks recommended replacement schedule and up to 6 nights of extended (overnight) wear.
| Study group | Role | What they receive |
|---|---|---|
| Lotrafilcon B multifocal | Experimental | Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis Receives: Device: Lotrafilcon B multifocal contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Convenience With Contact Lenses
Overall convenience with contact lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 3 weeks of wear time. Overall convenience is measured on a 4-point scale: 1=very satisfied; 2=satisfied; 3=dissatisfied; 4=very dissatisfied. Results were reported as a percentage of participants who responded, "very satisfied" or "satisfied."
Measured: 3 weeks of wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionFeb 2011
- Study completionFeb 2011
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 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
- NCT01268501
- Sponsor's protocol ID
- P-319-C-019
- Status last verified
- Feb 2012
- First submitted
- 29 Dec 2010
- Last updated
- 29 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 Assessment of a New Multifocal Contact Lens With Emmetropic Presbyopes
- ClinicalTrials.gov ID
- NCT01268501
- Acronym / sponsor ID
- P-319-C-019
- Conditions
- Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- CIBA VISIONIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 31 Dec 2010 (estimated)
- Results
- Posted 9 Feb 2012
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 this trial is to evaluate the use of multifocal contact lenses in people who use reading glasses only.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lotrafilcon B multifocal | Experimental | Device: Lotrafilcon B multifocal contact lensLotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis |
Who may qualify
- Ages
- 40 to 48 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Is between 40 and 48 years of age (inclusive).
- Has read and signed the Informed Consent.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Wears reading spectacles for close work.
- Other protocol-defined inclusion/exclusion criteria may apply.
Key exclusion criteria (5 listed)
- Eye injury or surgery within twelve weeks of enrollment.
- Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions.
- Currently enrolled in a clinical trial.
- Has worn contact lenses previously.
- Other protocol-defined inclusion/exclusion criteria may apply.
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 B multifocal contact lensAlso: AIR OPTIX® AQUA MULTIFOCALCommercially marketed, silicone hydrogel, multifocal, soft contact lenses FDA-approved for up to 4 weeks recommended replacement schedule and up to 6 nights of extended (overnight) wear. | Device | Lotrafilcon B multifocal |
Primary outcome
Overall Convenience With Contact Lenses
Time frame: 3 weeks of wear
Overall convenience with contact lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 3 weeks of wear time. Overall convenience is measured on a 4-point scale: 1=very satisfied; 2=satisfied; 3=dissatisfied; 4=very dissatisfied. Results were reported as a percentage of participants who responded, "very satisfied" or "satisfied."
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 multifocal contact lens 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 5 inclusion and 5 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 9 Feb 2012). 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?
Overall Convenience With Contact Lenses (time frame: 3 weeks 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.