PresbyopiaNCT02235831
DAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance
A study testing Nelfilcon A MF contact lenses (DACP MF) and Nelfilcon A single vision contact lenses (DACP) in people with Presbyopia and Refractive Error, run by Alcon Research.
Trial summary
The purpose of this study is to evaluate the visual performance of DAILIES® Aqua Comfort Plus® (DACP) MF contact lens using new objective measurements. Read more about this study
- Who is it for?
- Ages 41 to 65 years
- Conditions the study is for
- Presbyopia, Refractive Error
- What is being tested?
- Nelfilcon A MF contact lenses (DACP MF) and Nelfilcon A single vision contact lenses (DACP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Oct 2014
- 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 41 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of soft contact lens wear (hydrogel or silicone hydrogel) in both eyes during the past 3 months and able to wear lenses at least 8 hours a day, 5 days a week
- Spectacle add between +1.50 and +2.50 diopters (D) (inclusive)
- Requiring lenses within the power range of both study contact lenses to be fitted
- Cylinder, if present, less or equal to 0.50D in both eyes at Visit 1
- Vision correctable to 20/30 (0.2 logMAR) or better in each eye at distance
- Acceptable fit with both study contact lenses
- Willing to wear lenses every day or at least for a minimum of 5 days per week 6 hours per day, every day if possible
- Other protocol-defined inclusion criteria may apply
Who cannot join
- Current multifocal contact lens wearer
- Current monovision wearer or failed attempt with monovision
- Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear
- Use of systemic or ocular medications which contact lens wear could be contraindicated as determined by the investigator
- Eye injury or surgery within 12 weeks immediately prior to enrollment in this trial
- Any moderate or severe ocular condition observed during the slitlamp examination at the enrollment visit
Show all 13Show fewer
- History of herpetic keratitis, ocular surgery or irregular cornea
- Prior refractive surgery (e.g. LASIK, PRK, etc)
- Monocular (only 1 eye with functional vision) or fit with only 1 lens
- Habitually uncorrected anisometropia >2.00D
- Clinically significant anisocoria
- Participation in any clinical trial within 30 days of the enrollment visit
- Other protocol-defined exclusion criteria may apply
About this study
Official title: DAILIES® AquaComfort Plus® MF - Comparative Assessment of Visual Performance Using Objective Measurements
The purpose of this study is to evaluate the visual performance of DAILIES® Aqua Comfort Plus® (DACP) MF contact lens using new objective measurements.
Read the detailed description
In this 3-treatment, 3-period, 6-sequence crossover study, each subject received all 3 products in randomized order and used 1 product at a time for a duration of 5±1 days before switching to the next assigned product.
- Conditions
- Presbyopia, Refractive Error
- Being tested
- Nelfilcon A MF contact lenses (DACP MF), Nelfilcon A single vision contact lenses (DACP)
- Keywords
- DACP MF, DAILIES AquaComfort Plus® Multifocal, presbyopia, visual performance
- Medical subject headings
- Presbyopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nelfilcon A MF contact lenses (DACP MF)Device
Multifocal contact lenses in Low, Medium, High Add
Nelfilcon A single vision contact lenses (DACP)Device
| Study group | Role | What they receive |
|---|---|---|
| DACP MF | Experimental | DACP MF worn first, followed by DACP and DACP MF (Low Add) as randomized. Lenses worn for 5±1 days, 6 hours per day, in a daily wear daily disposable modality. DACP MF will be worn bilaterally (in both eyes). Receives: Device: Nelfilcon A MF contact lenses (DACP MF); Device: Nelfilcon A single vision contact lenses (DACP) |
| DACP | Active comparator | DACP worn first, followed by DACP MF and DACP MF (Low Add), as randomized. Lenses worn for 5±1 days, 6 hours per day, in a daily wear daily disposable modality. DACP worn as monovision (distance correction in one eye and near correction in the other eye). Receives: Device: Nelfilcon A MF contact lenses (DACP MF); Device: Nelfilcon A single vision contact lenses (DACP) |
| DACP MF (Low Add) | Active comparator | DACP MF (Low Add) worn first, followed by DACP and DACP MF, as randomized. Lenses worn for 5±1 days, 6 hours per day, in a daily wear daily disposable modality. DACP MF (Low Add) worn bilaterally (in both eyes). Receives: Device: Nelfilcon A MF contact lenses (DACP MF); Device: Nelfilcon A single vision contact lenses (DACP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area for Each Region (Near and Intermediate) Under the Mean Defocus Curve (AUC) at High Luminance
Visual acuity was measured with contact lenses in place using an Early Treatment Diabetic Retinopathy Study (ETDRS) high contrast logMAR chart under well-lit conditions. Lenses of different spherical powers (+2.00 diopter to -5.00 diopter) were placed in front of the eyes to produce varying levels of defocus, and logMAR acuity at each defocus value was recorded. The area under the defocus curve (AUC) was calculated via the trapezoidal rule for the entire study population by treatment using a 0.3 logMAR threshold for intermediate from -2.00 D (50cm) to -0.50 D (2m) and near from -4.00 D (25cm) to -2.00 D (50cm). A higher value indicates a bigger area of focus. This outcome measure was prespecified for monovision and DACP MF.
Measured: Day 5, each product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionOct 2014
- Study completionOct 2014
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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Manager, EMEA, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235831
- Sponsor's protocol ID
- CLT330-P001
- Status last verified
- Jun 2016
- First submitted
- 8 Sep 2014
- Last updated
- 11 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DAILIES® AquaComfort Plus® MF - Comparative Assessment of Visual Performance Using Objective Measurements
- ClinicalTrials.gov ID
- NCT02235831
- Acronym / sponsor ID
- CLT330-P001
- Conditions
- Presbyopia, Refractive Error
- Keywords
- DACP MF, DAILIES AquaComfort Plus® Multifocal, presbyopia, visual performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 10 Sep 2014 (estimated)
- Results
- Posted 18 Jan 2016
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 evaluate the visual performance of DAILIES® Aqua Comfort Plus® (DACP) MF contact lens using new objective measurements.
Detailed description
In this 3-treatment, 3-period, 6-sequence crossover study, each subject received all 3 products in randomized order and used 1 product at a time for a duration of 5±1 days before switching to the next assigned product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DACP MF | Experimental | Device: Nelfilcon A MF contact lenses (DACP MF), Device: Nelfilcon A single vision contact lenses (DACP)DACP MF worn first, followed by DACP and DACP MF (Low Add) as randomized. Lenses worn for 5±1 days, 6 hours per day, in a daily wear daily disposable modality. DACP MF will be worn bilaterally (in both eyes). |
| DACP | Active comparator | Device: Nelfilcon A MF contact lenses (DACP MF), Device: Nelfilcon A single vision contact lenses (DACP)DACP worn first, followed by DACP MF and DACP MF (Low Add), as randomized. Lenses worn for 5±1 days, 6 hours per day, in a daily wear daily disposable modality. DACP worn as monovision (distance correction in one eye and near correction in the other eye). |
| DACP MF (Low Add) | Active comparator | Device: Nelfilcon A MF contact lenses (DACP MF), Device: Nelfilcon A single vision contact lenses (DACP)DACP MF (Low Add) worn first, followed by DACP and DACP MF, as randomized. Lenses worn for 5±1 days, 6 hours per day, in a daily wear daily disposable modality. DACP MF (Low Add) worn bilaterally (in both eyes). |
Who may qualify
- Ages
- 41 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- History of soft contact lens wear (hydrogel or silicone hydrogel) in both eyes during the past 3 months and able to wear lenses at least 8 hours a day, 5 days a week
- Spectacle add between +1.50 and +2.50 diopters (D) (inclusive)
- Requiring lenses within the power range of both study contact lenses to be fitted
- Cylinder, if present, less or equal to 0.50D in both eyes at Visit 1
- Vision correctable to 20/30 (0.2 logMAR) or better in each eye at distance
Key exclusion criteria (13 listed)
- Current multifocal contact lens wearer
- Current monovision wearer or failed attempt with monovision
- Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear
- Use of systemic or ocular medications which contact lens wear could be contraindicated as determined by the investigator
- Eye injury or surgery within 12 weeks immediately prior to enrollment in this trial
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 |
|---|---|---|
| Nelfilcon A MF contact lenses (DACP MF)Multifocal contact lenses in Low, Medium, High Add | Device | DACP, DACP MF, DACP MF (Low Add) |
| Nelfilcon A single vision contact lenses (DACP) | Device | DACP, DACP MF, DACP MF (Low Add) |
Primary outcome
Area for Each Region (Near and Intermediate) Under the Mean Defocus Curve (AUC) at High Luminance
Time frame: Day 5, each product
Visual acuity was measured with contact lenses in place using an Early Treatment Diabetic Retinopathy Study (ETDRS) high contrast logMAR chart under well-lit conditions. Lenses of different spherical powers (+2.00 diopter to -5.00 diopter) were placed in front of the eyes to produce varying levels of defocus, and logMAR acuity at each defocus value was recorded. The area under the defocus curve (AUC) was calculated via the trapezoidal rule for the entire study population by treatment using a 0.3 logMAR threshold for intermediate from -2.00 D (50cm) to -0.50 D (2m) and near from -4.00 D (25cm) to -2.00 D (50cm). A higher value indicates a bigger area of focus. This outcome measure was prespecified for monovision and DACP MF.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Presbyopia
Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
Presbyopia
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.
Clinical Manager, EMEA study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A study testing Nelfilcon A MF contact lenses (DACP MF) and Nelfilcon A single vision contact lenses (DACP) in people with Presbyopia and Refractive Error, 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 13 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 11 Jul 2016. 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 18 Jan 2016). 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?
Area for Each Region (Near and Intermediate) Under the Mean Defocus Curve (AUC) at High Luminance (time frame: Day 5, each product). 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 11 Jul 2016.