PresbyopiaNCT01250054
Comparison of Two Multifocal Contact Lenses
A study testing Lotrafilcon B contact lens and Comfilcon A contact lens in people with Presbyopia, run by CIBA VISION.
Trial summary
The purpose of this study is to compare two multifocal contact lenses in presbyopic wearers. 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 contact lens and Comfilcon A contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Oct 2010
- 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
- At least 35 years of age.
- Sign written Informed Consent
- Spectacle add of +0.50 to +2.50D.
- Best corrected visual acuity of at least 20.30 in both eyes.
- Currently wearing soft contact lenses at least 5 days per week.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Eye injury or surgery within twelve weeks of enrollment.
- Currently enrolled in any clinical trial.
- Astigmatism > 1.00D.
- Strabismus/amblyopia.
- Other protocol-defined exclusion criteria may apply.
About this study
The purpose of this study is to compare two multifocal contact lenses in presbyopic wearers.
- Conditions
- Presbyopia
- Being tested
- Lotrafilcon B contact lens, Comfilcon A 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 contact lensDevice
Also called AIR OPTIX AQUA MULTIFOCAL
Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use
Comfilcon A contact lensDevice
Also called BIOFINITY MULTIFOCAL
Commercially marketed (Europe), silicone hydrogel, multifocal contact lens for daily wear use
| Study group | Role | What they receive |
|---|---|---|
| Lotrafilcon B / Comfilcon A | Other | Lotrafilcon B multifocal contact lenses worn first, with comfilcon A multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week. Receives: Device: Lotrafilcon B contact lens; Device: Comfilcon A contact lens |
| Comfilcon A /Lotrafilcon B | Other | Comfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week. Receives: Device: Lotrafilcon B contact lens; Device: Comfilcon A contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Vision
Overall vision, as interpreted by the participant and recorded by the investigator as a single, retrospective evaluation of one week's wear time. Overall vision was measured on a 10-point scale, with 1 being worst and 10 being best.
Measured: One 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 posted30 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2010
- Study completionOct 2010
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
- 17 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
- NCT01250054
- Sponsor's protocol ID
- P-319-C-018
- Status last verified
- Jul 2011
- First submitted
- 29 Nov 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
- Comparison of Two Multifocal Contact Lenses
- ClinicalTrials.gov ID
- NCT01250054
- Acronym / sponsor ID
- P-319-C-018
- Conditions
- Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- CIBA VISIONIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 30 Nov 2010 (estimated)
- Results
- Posted 12 Aug 2011
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 study is to compare two multifocal contact lenses in presbyopic wearers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lotrafilcon B / Comfilcon A | Other | Device: Lotrafilcon B contact lens, Device: Comfilcon A contact lensLotrafilcon B multifocal contact lenses worn first, with comfilcon A multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week. |
| Comfilcon A /Lotrafilcon B | Other | Device: Lotrafilcon B contact lens, Device: Comfilcon A contact lensComfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 35 years of age.
- Sign written Informed Consent
- Spectacle add of +0.50 to +2.50D.
- Best corrected visual acuity of at least 20.30 in both eyes.
- Currently wearing soft contact lenses at least 5 days per week.
Key exclusion criteria (5 listed)
- Eye injury or surgery within twelve weeks of enrollment.
- Currently enrolled in any clinical trial.
- Astigmatism > 1.00D.
- Strabismus/amblyopia.
- Other protocol-defined 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 contact lensAlso: AIR OPTIX AQUA MULTIFOCALCommercially marketed, silicone hydrogel, multifocal contact lens for daily wear use | Device | Comfilcon A /Lotrafilcon B, Lotrafilcon B / Comfilcon A |
| Comfilcon A contact lensAlso: BIOFINITY MULTIFOCALCommercially marketed (Europe), silicone hydrogel, multifocal contact lens for daily wear use | Device | Comfilcon A /Lotrafilcon B, Lotrafilcon B / Comfilcon A |
Primary outcome
Overall Vision
Time frame: One week of wear
Overall vision, as interpreted by the participant and recorded by the investigator as a single, retrospective evaluation of one week's wear time. Overall vision was measured on a 10-point scale, with 1 being worst and 10 being best.
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 contact lens and Comfilcon A 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 6 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 12 Aug 2011). 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 Vision (time frame: One 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.