PresbyopiaNCT03118934
Assessing Fitting Guides in Alcon Multifocal Contact Lenses
A study testing Lotrafilcon B multifocal contact lenses, Nelfilcon A multifocal contact lenses and Delefilcon A multifocal contact lenses in people with Presbyopia and Refractive Errors, run by Alcon Research at 20 sites in 3 countries.
Trial summary
The purpose of this study is to compare an alternative fitting guide to a current fitting guide for optimizing contact lens parameters and determining contact lens prescription. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Presbyopia, Refractive Errors
- What is being tested?
- Lotrafilcon B multifocal contact lenses, Nelfilcon A multifocal contact lenses and Delefilcon A multifocal contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 20 sitesin 3 countries
- Study dates
- 17 May 2017to 28 Jul 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign informed consent;
- Normal eyes;
- Current full-time soft contact lens wearer needing presbyopia correction;
- Willing to wear lenses for a minimum of five days per week, six hours per day, and attend all study visits;
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the Investigator;
- Eye conditions (past or present) as specified in the protocol;
- Currently wearing Alcon multifocal (MF) contact lenses;
- Only one eye with functional vision;
- Contact lens wear in one eye only;
- Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
20 sites in 3 countries.
20 sites in 3 countries
United States14 sites
Alcon Investigative Site
Ann Arbor, Michigan, 48105
Alcon Investigative Site
Eden Prairie, Minnesota, 55344
Alcon Investigative Site
Medina, Minnesota, 55340
Alcon Investigative Site
Memphis, Tennessee, 38104
Alcon Investigative Site
Memphis, Tennessee, 38119
Alcon Investigative Site
Pensacola, Florida, 32503
Alcon Investigative Site
Phoenix, Arizona, 85032
Alcon Investigative Site
Pittsburg, Kansas, 66762
Alcon Investigative Site
Powell, Ohio, 43065
Alcon Investigative Site
Raytown, Missouri, 64133
Alcon Investigative Site
San Diego, California, 92123
Alcon Investigative Site
Shawnee Mission, Kansas, 66204
Alcon Investigative Site
Tallahassee, Florida, 32308
Alcon Investigative Site
Warwick, Rhode Island, 02888
Canada3 sites
Alcon Investigative Site
Burnaby, British Columbia, V5E 1G3
Alcon Investigative Site
Toronto, Ontario, M2N 3A4
Alcon Investigative Site
Toronto, M2J2Z1
United Kingdom3 sites
Alcon Investigative Site
Coventry, CV49PQ
Alcon Investigative Site
Hereford, HR1 2PR
Alcon Investigative Site
Monmouth, NP25 3PS
About this study
The purpose of this study is to compare an alternative fitting guide to a current fitting guide for optimizing contact lens parameters and determining contact lens prescription.
- Conditions
- Presbyopia, Refractive Errors
- Being tested
- Lotrafilcon B multifocal contact lenses, Nelfilcon A multifocal contact lenses, Delefilcon A multifocal contact lenses
- Keywords
- contact lenses, presbyopia, multifocal
- 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.
Lotrafilcon B multifocal contact lensesDevice
Also called AIR OPTIX AQUA® Multifocal
Contact lenses for near, intermediate, and distance correction worn on a daily wear basis and cared for with participant's habitual lens care solution
Nelfilcon A multifocal contact lensesDevice
Also called DAILIES® AquaComfort Plus® Multifocal
Contact lenses for near, intermediate, and distance correction worn on a daily disposable basis (removed every night and discarded) with a new pair of study lenses every morning
Delefilcon A multifocal contact lensesDevice
Also called DAILIES TOTAL1® Multifocal
Contact lenses for near, intermediate, and distance correction worn on a daily disposable basis (removed every night and discarded) with a new pair of study lenses every morning
| Study group | Role | What they receive |
|---|---|---|
| AOA MF | Experimental | Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 10 ± 3 days Receives: Device: Lotrafilcon B multifocal contact lenses |
| DACP MF | Experimental | Nelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days Receives: Device: Nelfilcon A multifocal contact lenses |
| DT1 MF | Experimental | Delefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days Receives: Device: Delefilcon A multifocal contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Number of Trial Lenses Needed to Fit Each Eye
The Investigator used a multi-focal contact lens fitting guide to determine which study lens to fit
Measured: VIsit 1/Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start17 May 2017
- Primary completion7 Jul 2017
- Study completion28 Jul 2017
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Manager, Vision Care, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118934
- Sponsor's protocol ID
- CLK027-P001
- Status last verified
- Aug 2018
- First submitted
- 11 Apr 2017
- Last updated
- 26 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Fitting Guides in Alcon Multifocal Contact Lenses
- ClinicalTrials.gov ID
- NCT03118934
- Acronym / sponsor ID
- CLK027-P001
- Conditions
- Presbyopia, Refractive Errors
- Keywords
- contact lenses, presbyopia, multifocal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 17 May 2017 (actual)
- Primary completion
- 7 Jul 2017 (actual)
- Study completion
- 28 Jul 2017 (actual)
- First posted
- 18 Apr 2017 (actual)
- Results
- Posted 26 Sep 2018
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 an alternative fitting guide to a current fitting guide for optimizing contact lens parameters and determining contact lens prescription.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AOA MF | Experimental | Device: Lotrafilcon B multifocal contact lensesLotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 10 ± 3 days |
| DACP MF | Experimental | Device: Nelfilcon A multifocal contact lensesNelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days |
| DT1 MF | Experimental | Device: Delefilcon A multifocal contact lensesDelefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sign informed consent;
- Normal eyes;
- Current full-time soft contact lens wearer needing presbyopia correction;
- Willing to wear lenses for a minimum of five days per week, six hours per day, and attend all study visits;
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (7 listed)
- Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the Investigator;
- Eye conditions (past or present) as specified in the protocol;
- Currently wearing Alcon multifocal (MF) contact lenses;
- Only one eye with functional vision;
- Contact lens wear in one eye only;
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 lensesAlso: AIR OPTIX AQUA® MultifocalContact lenses for near, intermediate, and distance correction worn on a daily wear basis and cared for with participant's habitual lens care solution | Device | AOA MF |
| Nelfilcon A multifocal contact lensesAlso: DAILIES® AquaComfort Plus® MultifocalContact lenses for near, intermediate, and distance correction worn on a daily disposable basis (removed every night and discarded) with a new pair of study lenses every morning | Device | DACP MF |
| Delefilcon A multifocal contact lensesAlso: DAILIES TOTAL1® MultifocalContact lenses for near, intermediate, and distance correction worn on a daily disposable basis (removed every night and discarded) with a new pair of study lenses every morning | Device | DT1 MF |
Primary outcome
Mean Number of Trial Lenses Needed to Fit Each Eye
Time frame: VIsit 1/Day 1
The Investigator used a multi-focal contact lens fitting guide to determine which study lens to fit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 Trial Manager, Vision Care study director
Alcon Research
20 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lotrafilcon B multifocal contact lenses, Nelfilcon A multifocal contact lenses and Delefilcon A multifocal contact lenses in people with Presbyopia and Refractive Errors, run by Alcon Research at 20 sites in 3 countries.
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 7 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 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 26 Sep 2018). 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 Number of Trial Lenses Needed to Fit Each Eye (time frame: VIsit 1/Day 1). 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 26 Sep 2018; AzTrials last refreshed its copy on 30 Oct 2026.