PresbyopiaNCT01951573
Evaluation of a New Daily Disposable Multifocal Contact Lens Design
A study testing Delefilcon A multifocal contact lenses and Lotrafilcon B multifocal contact lenses in people with Presbyopia and Hyperopia, run by Alcon Research.
Trial summary
The purpose of this study is to demonstrate non-inferiority of a new daily disposable multifocal contact lens in plus powers against the commercially available AIR OPTIX® AQUA MULTIFOCAL (AOAMF) lens in high contrast/high illumination (HC/HI) near visual acuity (VA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Presbyopia, Hyperopia, Refractive Error
- What is being tested?
- Delefilcon A multifocal contact lenses and Lotrafilcon B multifocal contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Nov 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with normal eyes who are not using any ocular medication.
- Must sign the Informed Consent document.
- Habitual lens power within the range available for the study lenses (+1.00 to +3.50 diopters(D)).
- Manifest cylinder less than or equal to 0.75D.
- Best corrected distance VA greater than or equal to 20/25 in each eye.
- Existing soft contact lens (CL) wearers who wear contact lenses in both eyes at least 5 days per week.
- Presbyopic with a spectacle addition (ADD) >0.50D and <2.75D.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Any ocular disease, inflammation, or abnormality that contraindicates CL wear.
- Any use of systemic or ocular medications for which CL wear could be contraindicated.
- History of herpetic keratitis.
- History of refractive surgery or irregular cornea.
- A clinically significant dry eye that precludes CL wear.
- Participation of the subject in a clinical study (including CL or CL care product) within the previous 30 days.
Show all 9Show fewer
- Monocular (only 1 eye with functional vision).
- History of intolerance or hypersensitivity to any component of the test articles.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: Delefilcon A Multifocal Plus Power Lens Design Evaluation
The purpose of this study is to demonstrate non-inferiority of a new daily disposable multifocal contact lens in plus powers against the commercially available AIR OPTIX® AQUA MULTIFOCAL (AOAMF) lens in high contrast/high illumination (HC/HI) near visual acuity (VA).
- Conditions
- Presbyopia, Hyperopia, Refractive Error
- Being tested
- Delefilcon A multifocal contact lenses, Lotrafilcon B multifocal contact lenses
- Keywords
- contact lenses, multifocal, daily disposable, silicone hydrogel, presbyopia
- Medical subject headings
- Presbyopia, Hyperopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delefilcon A multifocal contact lensesDevice
Silicone hydrogel multifocal contact lenses for daily wear, daily disposable use
Lotrafilcon B multifocal contact lensesDevice
Also called AIR OPTIX® AQUA MULTIFOCAL
Silicone hydrogel multifocal contact lenses with a labeled indication for daily wear and extended wear use of up to 6 days with monthly replacement
| Study group | Role | What they receive |
|---|---|---|
| Delefilcon A MF, then AOAMF | Other | Delefilcon A multifocal contact lenses first, followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally (ie, in both eyes) for 9-12 hours, with a 1-8 day washout separating the 2 wear periods. Receives: Device: Delefilcon A multifocal contact lenses; Device: Lotrafilcon B multifocal contact lenses |
| AOAMF, then Delefilcon A MF | Other | Lotrafilcon B multifocal contact lenses first, followed by delefilcon A multifocal contact lenses. Each product worn bilaterally (ie, in both eyes) for 9-12 hours, with a 1-8 day washout separating the 2 wear periods. Receives: Device: Delefilcon A multifocal contact lenses; Device: Lotrafilcon B multifocal contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
High Contrast/High Illumination (HC/HI) Binocular Visual Acuity (VA) at Near
Near VA was assessed binocularly (both eyes together) at 40 centimeters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.
Measured: Dispense (Day 1), Hour 9
Secondary outcomes (2)
HC/HI Binocular VA at Distance
Distance VA was assessed binocularly (both eyes together) at 6 meters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.
Measured: Dispense (Day 1), Hour 9
Over-refraction (OR) Monocular at Distance
OR (the amount of additional correction needed to improve VA) at distance (equivalent to 6 meters) was assessed monocularly (for each eye separately) in diopters (D). Both eyes contributed to the mean.
Measured: Dispense (Day 1), Hour 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2013
- Study completionNov 2013
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.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joachim Nick, Dipl. Ing., Study director, CIBA VISION GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01951573
- Sponsor's protocol ID
- C-13-011
- Status last verified
- Nov 2014
- First submitted
- 24 Sep 2013
- Last updated
- 2 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delefilcon A Multifocal Plus Power Lens Design Evaluation
- ClinicalTrials.gov ID
- NCT01951573
- Acronym / sponsor ID
- C-13-011
- Conditions
- Presbyopia, Hyperopia, Refractive Error
- Keywords
- contact lenses, multifocal, daily disposable, silicone hydrogel, presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 26 Sep 2013 (estimated)
- Results
- Posted 2 Dec 2014
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 demonstrate non-inferiority of a new daily disposable multifocal contact lens in plus powers against the commercially available AIR OPTIX® AQUA MULTIFOCAL (AOAMF) lens in high contrast/high illumination (HC/HI) near visual acuity (VA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delefilcon A MF, then AOAMF | Other | Device: Delefilcon A multifocal contact lenses, Device: Lotrafilcon B multifocal contact lensesDelefilcon A multifocal contact lenses first, followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally (ie, in both eyes) for 9-12 hours, with a 1-8 day washout separating the 2 wear periods. |
| AOAMF, then Delefilcon A MF | Other | Device: Delefilcon A multifocal contact lenses, Device: Lotrafilcon B multifocal contact lensesLotrafilcon B multifocal contact lenses first, followed by delefilcon A multifocal contact lenses. Each product worn bilaterally (ie, in both eyes) for 9-12 hours, with a 1-8 day washout separating the 2 wear periods. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects with normal eyes who are not using any ocular medication.
- Must sign the Informed Consent document.
- Habitual lens power within the range available for the study lenses (+1.00 to +3.50 diopters(D)).
- Manifest cylinder less than or equal to 0.75D.
- Best corrected distance VA greater than or equal to 20/25 in each eye.
Key exclusion criteria (9 listed)
- Any ocular disease, inflammation, or abnormality that contraindicates CL wear.
- Any use of systemic or ocular medications for which CL wear could be contraindicated.
- History of herpetic keratitis.
- History of refractive surgery or irregular cornea.
- A clinically significant dry eye that precludes CL wear.
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 |
|---|---|---|
| Delefilcon A multifocal contact lensesSilicone hydrogel multifocal contact lenses for daily wear, daily disposable use | Device | AOAMF, then Delefilcon A MF, Delefilcon A MF, then AOAMF |
| Lotrafilcon B multifocal contact lensesAlso: AIR OPTIX® AQUA MULTIFOCALSilicone hydrogel multifocal contact lenses with a labeled indication for daily wear and extended wear use of up to 6 days with monthly replacement | Device | AOAMF, then Delefilcon A MF, Delefilcon A MF, then AOAMF |
Primary outcome
High Contrast/High Illumination (HC/HI) Binocular Visual Acuity (VA) at Near
Time frame: Dispense (Day 1), Hour 9
Near VA was assessed binocularly (both eyes together) at 40 centimeters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.
2 secondary outcomes
HC/HI Binocular VA at Distance
Time frame: Dispense (Day 1), Hour 9
Over-refraction (OR) Monocular at Distance
Time frame: Dispense (Day 1), Hour 9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
- 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.
Joachim Nick, Dipl. Ing. study director
CIBA VISION GmbH
Questions about this trial
What is this clinical trial studying?
A study testing Delefilcon A multifocal contact lenses and Lotrafilcon B multifocal contact lenses in people with Presbyopia and Hyperopia, run by Alcon Research.
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 8 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 2 Dec 2014. 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 2 Dec 2014). 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?
High Contrast/High Illumination (HC/HI) Binocular Visual Acuity (VA) at Near (time frame: Dispense (Day 1), Hour 9). 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 2 Dec 2014.