PresbyopiaNCT02403180
DAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance
A study testing DACP MF and PROCLEAR 1D MF in people with Presbyopia, run by Alcon Research.
Trial summary
The purpose of this study is to evaluate the visual performance of DACP MF and PROCLEAR 1D MF daily disposable contact lenses in an established presbyopic population. Read more about this study
- Who is it for?
- Ages 41 to 65 years
- Conditions the study is for
- Presbyopia
- What is being tested?
- DACP MF and PROCLEAR 1D MF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Jul 2015
- 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
- Must sign an informed consent;
- Adapted soft contact lens wearer;
- Vision correctable to 20/30 [(0.2 logMAR (logarithm of the minimum angle of resolution)] or better in each eye at distance;
- Willing to wear lenses every day or for at least 5 days per week, 6 hours per day;
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Currently wearing multifocal contact lenses;
- Currently wearing monovision;
- Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
- Use of systemic or ocular medications which could contraindicate contact lens wear;
- Eye injury or surgery within 12 weeks prior to enrollment;
- Prior refractive surgery;
- Monocular (only 1 eye with functional vision) or fit with only 1 lens;
- Other protocol-specified exclusion criteria may apply.
About this study
Official title: Comparative Assessment of Visual Performance Between DAILIES® AquaComfort Plus® (DACP) Multifocal (MF) and PROCLEAR 1 Day Multifocal (PROCLEAR 1D MF)
The purpose of this study is to evaluate the visual performance of DACP MF and PROCLEAR 1D MF daily disposable contact lenses in an established presbyopic population.
- Conditions
- Presbyopia
- Being tested
- DACP MF, PROCLEAR 1D MF
- Keywords
- Visual Performance
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DACP MFDevice
Also called DAILIES® AquaComfort Plus® Multifocal (DACP MF), Nelfilcon A
Nelfilcon A multifocal contact lenses
PROCLEAR 1D MFDevice
Also called PROCLEAR® 1 DAY MULTIFOCAL (PROCLEAR 1D MF), Omafilcon A
Omafilcon A multifocal contact lenses
| Study group | Role | What they receive |
|---|---|---|
| DACP MF, then PROCLEAR 1D MF | Other | DACP MF (nelfilcon A) multifocal contact lenses worn in Period 1, followed by PROCLEAR 1D MF (omafilcon A) multifocal contact lenses worn in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality. Receives: Device: DACP MF; Device: PROCLEAR 1D MF |
| PROCLEAR 1D MF, then DACP MF | Other | PROCLEAR 1D MF (omafilcon A) multifocal contact lenses worn in Period 1, followed by DACP MF (nelfilcon A) multifocal contact lenses worn in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality. Receives: Device: DACP MF; Device: PROCLEAR 1D MF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Stereoacuity at Near After 5+/-1 Days of Contact Lens Wear
Stereoacuity (SA) is the ability to detect differences in distance (depth perception). Near SA was measured at a distance of 40 cm using the Howard-Dolman system. A lower SA value indicates better depth perception.
Measured: Day 5, each product
Secondary outcomes (1)
Mean Area of Focus Under the Mean Defocus Curve After 5 +/- 1 Days of Contact Lens Wear
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. Trial 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.
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 posted31 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2015
- Study completionJul 2015
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, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Manager, Study director, Alcon, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403180
- Sponsor's protocol ID
- CLW681-P001
- Status last verified
- Jul 2016
- First submitted
- 26 Mar 2015
- Last updated
- 18 Aug 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 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Assessment of Visual Performance Between DAILIES® AquaComfort Plus® (DACP) Multifocal (MF) and PROCLEAR 1 Day Multifocal (PROCLEAR 1D MF)
- ClinicalTrials.gov ID
- NCT02403180
- Acronym / sponsor ID
- CLW681-P001
- Conditions
- Presbyopia
- Keywords
- Visual Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Posted 18 Aug 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 DACP MF and PROCLEAR 1D MF daily disposable contact lenses in an established presbyopic population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DACP MF, then PROCLEAR 1D MF | Other | Device: DACP MF, Device: PROCLEAR 1D MFDACP MF (nelfilcon A) multifocal contact lenses worn in Period 1, followed by PROCLEAR 1D MF (omafilcon A) multifocal contact lenses worn in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality. |
| PROCLEAR 1D MF, then DACP MF | Other | Device: DACP MF, Device: PROCLEAR 1D MFPROCLEAR 1D MF (omafilcon A) multifocal contact lenses worn in Period 1, followed by DACP MF (nelfilcon A) multifocal contact lenses worn in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality. |
Who may qualify
- Ages
- 41 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must sign an informed consent;
- Adapted soft contact lens wearer;
- Vision correctable to 20/30 [(0.2 logMAR (logarithm of the minimum angle of resolution)] or better in each eye at distance;
- Willing to wear lenses every day or for at least 5 days per week, 6 hours per day;
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (8 listed)
- Currently wearing multifocal contact lenses;
- Currently wearing monovision;
- Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
- Use of systemic or ocular medications which could contraindicate contact lens wear;
- Eye injury or surgery within 12 weeks prior to enrollment;
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 |
|---|---|---|
| DACP MFAlso: DAILIES® AquaComfort Plus® Multifocal (DACP MF), Nelfilcon ANelfilcon A multifocal contact lenses | Device | DACP MF, then PROCLEAR 1D MF, PROCLEAR 1D MF, then DACP MF |
| PROCLEAR 1D MFAlso: PROCLEAR® 1 DAY MULTIFOCAL (PROCLEAR 1D MF), Omafilcon AOmafilcon A multifocal contact lenses | Device | DACP MF, then PROCLEAR 1D MF, PROCLEAR 1D MF, then DACP MF |
Primary outcome
Mean Stereoacuity at Near After 5+/-1 Days of Contact Lens Wear
Time frame: Day 5, each product
Stereoacuity (SA) is the ability to detect differences in distance (depth perception). Near SA was measured at a distance of 40 cm using the Howard-Dolman system. A lower SA value indicates better depth perception.
1 secondary outcome
Mean Area of Focus Under the Mean Defocus Curve After 5 +/- 1 Days of Contact Lens Wear
Time frame: Day 5, each product
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2016.
- 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.
Clinical Manager study director
Alcon, Spain
Questions about this trial
What is this clinical trial studying?
A study testing DACP MF and PROCLEAR 1D MF in people with Presbyopia, 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 5 inclusion and 8 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 18 Aug 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 Aug 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?
Mean Stereoacuity at Near After 5+/-1 Days of Contact Lens Wear (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 18 Aug 2016.