PresbyopiaNCT01518868
A Study to Evaluate the Feasibility of a High Add Multi Focal Contact Lens
A study testing Investigational contact lens and PureVision contact lens in people with Presbyopia, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
The objective of this study is to evaluate the product performance of the investigational multifocal high add soft contact lens compared with PureVision Multi-focal contact lens on a daily wear basis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Presbyopia
- What is being tested?
- Investigational contact lens and PureVision contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Feb 2012
- 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
- Have physiologically normal anterior segments
- Be adapted wearers of soft contact lenses and wear a lens in each eye.
- Be presbyopic and require near add correction in each eye.
- Be an adapted monovision or multifocal contact lens wearer or be an adapted spherical lens wearer who also uses spectacles for near vision correction.
- Have no active ocular disease or allergic conjunctivitis.
- Must not be using any topical ocular medications.
- Must habitually use a lens care product for lens cleaning, disinfecting, and storage.
Who cannot join
- Any Grade 2 or greater finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- Anisometropia (spherical equivalent) of greater than 2.00 D.
- Any systemic disease affecting ocular health.
- Using any systemic or topical medications that will affect ocular physiology or lens performance.
- Allergic to any component in the study products.
Show all 12Show fewer
- Ocular astigmatism of greater than 1.00 D in either eye.
- Have had any corneal surgery (ie, refractive surgery).
- Uses AMO Ultra Care as their habitual lens care regimen.
- Is a toric contact lens wearer.
- Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months.
- An active ocular disease (for example but not limited to papillary conjunctivitis, any conjunctivitis: viral, bacterial, allergic), any corneal infiltrative response or are using any ocular medications.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bausch & Lomb, Incorporated
Rochester, New York, 14609
About this study
The objective of this study is to evaluate the product performance of the investigational multifocal high add soft contact lens compared with PureVision Multi-focal contact lens on a daily wear basis.
- Conditions
- Presbyopia
- Being tested
- Investigational contact lens, PureVision contact lens
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational contact lensDevice
Worn on a daily wear basis for one week.
PureVision contact lensDevice
Worn on a daily wear basis for one week
| Study group | Role | What they receive |
|---|---|---|
| Investigational contact lens | Experimental | multifocal high add soft contact lens Receives: Device: Investigational contact lens |
| PureVision contact lens | Active comparator | Multi-focal contact lens Receives: Device: PureVision contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
Measured: At 2 weeks follow up
Secondary outcomes (1)
Symptoms/Complaints
Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.
Measured: At 2 weeks follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionFeb 2012
- Study completionFeb 2012
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beverly J Barna, CCRA, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518868
- Sponsor's protocol ID
- 743E
- Status last verified
- Sep 2020
- First submitted
- 24 Jan 2012
- Last updated
- 30 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Feasibility of a High Add Multi Focal Contact Lens
- ClinicalTrials.gov ID
- NCT01518868
- Acronym / sponsor ID
- 743E
- Conditions
- Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 26 Jan 2012 (estimated)
- Results
- Posted 30 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the product performance of the investigational multifocal high add soft contact lens compared with PureVision Multi-focal contact lens on a daily wear basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational contact lens | Experimental | Device: Investigational contact lensmultifocal high add soft contact lens |
| PureVision contact lens | Active comparator | Device: PureVision contact lensMulti-focal contact lens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have physiologically normal anterior segments
- Be adapted wearers of soft contact lenses and wear a lens in each eye.
- Be presbyopic and require near add correction in each eye.
- Be an adapted monovision or multifocal contact lens wearer or be an adapted spherical lens wearer who also uses spectacles for near vision correction.
- Have no active ocular disease or allergic conjunctivitis.
Key exclusion criteria (12 listed)
- Any Grade 2 or greater finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- Anisometropia (spherical equivalent) of greater than 2.00 D.
- Any systemic disease affecting ocular health.
- Using any systemic or topical medications that will affect ocular physiology or lens performance.
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 |
|---|---|---|
| Investigational contact lensWorn on a daily wear basis for one week. | Device | Investigational contact lens |
| PureVision contact lensWorn on a daily wear basis for one week | Device | PureVision contact lens |
Primary outcome
Visual Acuity
Time frame: At 2 weeks follow up
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
1 secondary outcome
Symptoms/Complaints
Time frame: At 2 weeks follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- 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.
Beverly J Barna, CCRA study director
Bausch & Lomb Incorporated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational contact lens and PureVision contact lens in people with Presbyopia, run by Bausch & Lomb Incorporated at 1 site in United States.
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 7 inclusion and 12 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 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 30 Sep 2020). 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?
Visual Acuity (time frame: At 2 weeks follow up). 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 30 Sep 2020.