PresbyopiaNCT02117544
Multifocal High ADD Contact Lens Proof of Concept Trial
A study testing Lotrafilcon B multifocal contact lenses (new) and Lotrafilcon B multifocal contact lenses in people with Presbyopia, run by Alcon Research.
Trial summary
The purpose of this study is to evaluate the visual performance of a new multifocal High ADD contact lens compared to the currently-marketed AIR OPTIX® AQUA MULTIFOCAL (AOAMF) High ADD Contact Lens. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Presbyopia
- What is being tested?
- Lotrafilcon B multifocal contact lenses (new) 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
- 268 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Jul 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must sign an Informed Consent document;
- Presbyopic and require at least 2.25 diopters (D) spectacle ADD power;
- Current or previous soft contact lens wearer;
- Not able to achieve monocular near visual acuity (VA) 0.2 logarithm of the Minimum Angle of Resolution (logMAR) [Early Treatment of Diabetic Retinopathy Study (ETDRS)] or better in each eye with AIR OPTIX® AQUA Multifocal (AOAMF) High ADD Contact Lenses;
- Willing and able to wear multifocal contact lenses in both eyes within the available range of powers for this trial;
- Manifest cylinder less than or equal to 1.00 D;
- Able to achieve best corrected visual acuity (BCVA) of 20/25 or better in each eye at distance (as determined by manifest refraction);
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment, as determined by the investigator;
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator; or any use of topical ocular medications that would require instillation during contact lens wear;
- Any history of herpetic keratitis;
- History of corneal or refractive surgery, irregular cornea or unilateral pseudophakia;
- Biomicroscopy findings (except for corneal vascularization) that are moderate (Grade 3) or severe (Grade 4);
- Corneal vascularization that is mild (Grade 2) or higher;
Show all 15Show fewer
- A pathologically dry eye that precludes contact lens wear;
- Monocular (only 1 eye with functional vision);
- Anisometropia ≥ 1.50 D (contact lens distance prescription);
- Clinically significant (> 1 millimeter) anisocoria;
- History of intolerance or hypersensitivity to any component of the investigational products;
- Concurrent participation in a contact lens or contact lens care product clinical trial within the previous 30 days;
- Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment;
- Any ocular or systemic medical condition that may, in the opinion of the Investigator, preclude safe administration of the study lenses or affect the results of this study;
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: Evaluation of Visual Performance With a Multifocal High ADD Soft Contact Lens Design
The purpose of this study is to evaluate the visual performance of a new multifocal High ADD contact lens compared to the currently-marketed AIR OPTIX® AQUA MULTIFOCAL (AOAMF) High ADD Contact Lens.
- Conditions
- Presbyopia
- Being tested
- Lotrafilcon B multifocal contact lenses (new), Lotrafilcon B multifocal contact lenses
- Keywords
- Contact lens, Presbyopia, Multifocal
- 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 multifocal contact lenses (new)Device
Lotrafilcon B multifocal contact lensesDevice
Also called AIR OPTIX® AQUA Multifocal, AOAMF
| Study group | Role | What they receive |
|---|---|---|
| New MF, then AOAMF | Other | Lotrafilcon B multifocal contact lenses (new), followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally (in both eyes) for about 1 hour. Receives: Device: Lotrafilcon B multifocal contact lenses (new); Device: Lotrafilcon B multifocal contact lenses |
| AOAMF, then New MF | Other | Lotrafilcon B multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses (new). Each product worn bilaterally (in both eyes) for about 1 hour. Receives: Device: Lotrafilcon B multifocal contact lenses (new); 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 Visual Acuity (HCVA) Near Monocular
Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 40 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.
Measured: Day 1, 10 minutes after lens insertion, each product
Secondary outcomes (3)
HCVA Distance Monocular
Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 6 meters using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.
Measured: Day 1, 10 minutes after lens insertion, each product
HCVA Intermediate Monocular
Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 1 meter using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.
Measured: Day 1, 10 minutes after lens insertion, each product
Low Contrast Visual Acuity (LCVA) Distance Monocular
Visual Acuity (clarity or sharpness of vision) was measured at low contrast level. LCVA was assessed monocularly (each eye separately) at 6 meters using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.
Measured: Day 1, 10 minutes after lens insertion, each product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2014
- Study completionJul 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sr. Clinical Manager, Vision Care, GCRA, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117544
- Sponsor's protocol ID
- C-13-057
- Status last verified
- Aug 2015
- First submitted
- 16 Apr 2014
- Last updated
- 26 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Visual Performance With a Multifocal High ADD Soft Contact Lens Design
- ClinicalTrials.gov ID
- NCT02117544
- Acronym / sponsor ID
- C-13-057
- Conditions
- Presbyopia
- Keywords
- Contact lens, Presbyopia, Multifocal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Posted 17 Aug 2015
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 a new multifocal High ADD contact lens compared to the currently-marketed AIR OPTIX® AQUA MULTIFOCAL (AOAMF) High ADD Contact Lens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New MF, then AOAMF | Other | Device: Lotrafilcon B multifocal contact lenses (new), Device: Lotrafilcon B multifocal contact lensesLotrafilcon B multifocal contact lenses (new), followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally (in both eyes) for about 1 hour. |
| AOAMF, then New MF | Other | Device: Lotrafilcon B multifocal contact lenses (new), Device: Lotrafilcon B multifocal contact lensesLotrafilcon B multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses (new). Each product worn bilaterally (in both eyes) for about 1 hour. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Must sign an Informed Consent document;
- Presbyopic and require at least 2.25 diopters (D) spectacle ADD power;
- Current or previous soft contact lens wearer;
- Not able to achieve monocular near visual acuity (VA) 0.2 logarithm of the Minimum Angle of Resolution (logMAR) [Early Treatment of Diabetic Retinopathy Study (ETDRS)] or better in each eye with AIR OPTIX® AQUA Multifocal (AOAMF) High ADD Contact Lenses;
- Willing and able to wear multifocal contact lenses in both eyes within the available range of powers for this trial;
Key exclusion criteria (15 listed)
- Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment, as determined by the investigator;
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator; or any use of topical ocular medications that would require instillation during contact lens wear;
- Any history of herpetic keratitis;
- History of corneal or refractive surgery, irregular cornea or unilateral pseudophakia;
- Biomicroscopy findings (except for corneal vascularization) that are moderate (Grade 3) or severe (Grade 4);
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 lenses (new) | Device | AOAMF, then New MF, New MF, then AOAMF |
| Lotrafilcon B multifocal contact lensesAlso: AIR OPTIX® AQUA Multifocal, AOAMF | Device | AOAMF, then New MF, New MF, then AOAMF |
Primary outcome
High Contrast Visual Acuity (HCVA) Near Monocular
Time frame: Day 1, 10 minutes after lens insertion, each product
Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 40 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.
3 secondary outcomes
HCVA Distance Monocular
Time frame: Day 1, 10 minutes after lens insertion, each product
HCVA Intermediate Monocular
Time frame: Day 1, 10 minutes after lens insertion, each product
Low Contrast Visual Acuity (LCVA) Distance Monocular
Time frame: Day 1, 10 minutes after lens insertion, each product
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2015.
- 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.
Sr. Clinical Manager, Vision Care, GCRA study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A study testing Lotrafilcon B multifocal contact lenses (new) and Lotrafilcon B multifocal contact lenses 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 8 inclusion and 15 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 Aug 2015. 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 17 Aug 2015). 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 Visual Acuity (HCVA) Near Monocular (time frame: Day 1, 10 minutes after lens insertion, 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 26 Aug 2015.