PresbyopiaGARMNCT00965237
Multifocal Contact Lens Use in Previous Contact Lens Wearers With Near Vision Demands
A study testing lotrafilcon B multifocal contact lens, lotrafilcon B single vision contact lens and Over-reader spectacles in people with Presbyopia, run by CIBA VISION at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the use of a multifocal contact lens in people who previously wore contact lenses but discontinued due to age-related, near vision demands. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Presbyopia
- What is being tested?
- lotrafilcon B multifocal contact lens, lotrafilcon B single vision contact lens and Over-reader spectacles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2009to Dec 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- has discontinued contact lens wear primarily due to age-related, near vision demands
- requires a reading add of +0.50 to +1.75 D (inclusive) and is correctable to at least 6/9 monocular, distance and near with spectacle correction
- has had an ocular examination in the last 2 years
- Other protocol-defined inclusion/exclusion criteria may apply
Who cannot join
- has any ocular disease
- has more than a 2.00D prescription difference between eyes
- cannot be fit successfully with the study contact lenses
- has any systemic disease affecting ocular health
- is using any systemic or topical medications that may affect ocular health
- has undergone corneal refractive surgery
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Waterloo Centre for Contact Lens Research
Waterloo, Ontario, N2L 3G1
About this study
Official title: P/331/09/C: Multifocal Pilot Study: Refitting Drop Outs (GARM)
The purpose of this study is to evaluate the use of a multifocal contact lens in people who previously wore contact lenses but discontinued due to age-related, near vision demands.
- Conditions
- Presbyopia
- Being tested
- lotrafilcon B multifocal contact lens, lotrafilcon B single vision contact lens, Over-reader spectacles
- 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 lensDevice
Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use
lotrafilcon B single vision contact lensDevice
Commercially marketed, silicone hydrogel, single vision contact lens for daily wear use
Over-reader spectaclesOther
Reading glasses worn over single vision contact lenses for near vision work on an as-needed basis
| Study group | Role | What they receive |
|---|---|---|
| Multifocal CL / Single vision CL + reading glasses | Other | Lotrafilcon B multifocal contact lenses (CL) worn first, with lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis. Receives: Device: lotrafilcon B multifocal contact lens; Device: lotrafilcon B single vision contact lens; Other: Over-reader spectacles |
| Single vision CL + reading glasses / Multifocal CL | Other | Lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn first, with lotrafilcon B multifocal contact lenses (CL) worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis. Receives: Device: lotrafilcon B multifocal contact lens; Device: lotrafilcon B single vision contact lens; Other: Over-reader spectacles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Satisfaction With the Lenses
Overall satisfaction with the lenses was interpreted by and assessed by the subject as a single, retrospective measurement of one week's wear time. Overall satisfaction with the lenses was recorded on a questionnaire as a numerical rating on a scale of 1 to 100, with 1 being completely dissatisfied, and 100 being excellent, completely satisfied.
Measured: 1 week of wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionDec 2009
- Study completionDec 2009
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
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- CIBA VISION
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Waterloo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00965237
- Sponsor's protocol ID
- P-368-C-101
- Acronym
- GARM
- Status last verified
- Jan 2012
- First submitted
- 24 Aug 2009
- Last updated
- 10 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- P/331/09/C: Multifocal Pilot Study: Refitting Drop Outs (GARM)
- ClinicalTrials.gov ID
- NCT00965237
- Acronym / sponsor ID
- GARM / P-368-C-101
- Conditions
- Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- CIBA VISIONIndustry (pharma, biotech, devices)
- Collaborators
- University of Waterloo
- Study start
- Aug 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 25 Aug 2009 (estimated)
- Results
- Posted 14 Mar 2011
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 use of a multifocal contact lens in people who previously wore contact lenses but discontinued due to age-related, near vision demands.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multifocal CL / Single vision CL + reading glasses | Other | Device: lotrafilcon B multifocal contact lens, Device: lotrafilcon B single vision contact lens, Other: Over-reader spectaclesLotrafilcon B multifocal contact lenses (CL) worn first, with lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis. |
| Single vision CL + reading glasses / Multifocal CL | Other | Device: lotrafilcon B multifocal contact lens, Device: lotrafilcon B single vision contact lens, Other: Over-reader spectaclesLotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn first, with lotrafilcon B multifocal contact lenses (CL) worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- has discontinued contact lens wear primarily due to age-related, near vision demands
- requires a reading add of +0.50 to +1.75 D (inclusive) and is correctable to at least 6/9 monocular, distance and near with spectacle correction
- has had an ocular examination in the last 2 years
- Other protocol-defined inclusion/exclusion criteria may apply
Key exclusion criteria (7 listed)
- has any ocular disease
- has more than a 2.00D prescription difference between eyes
- cannot be fit successfully with the study contact lenses
- has any systemic disease affecting ocular health
- is using any systemic or topical medications that may affect ocular health
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 lensCommercially marketed, silicone hydrogel, multifocal contact lens for daily wear use | Device | Multifocal CL / Single vision CL + reading glasses, Single vision CL + reading glasses / Multifocal CL |
| lotrafilcon B single vision contact lensCommercially marketed, silicone hydrogel, single vision contact lens for daily wear use | Device | Multifocal CL / Single vision CL + reading glasses, Single vision CL + reading glasses / Multifocal CL |
| Over-reader spectaclesReading glasses worn over single vision contact lenses for near vision work on an as-needed basis | Other | Multifocal CL / Single vision CL + reading glasses, Single vision CL + reading glasses / Multifocal CL |
Primary outcome
Overall Satisfaction With the Lenses
Time frame: 1 week of wear
Overall satisfaction with the lenses was interpreted by and assessed by the subject as a single, retrospective measurement of one week's wear time. Overall satisfaction with the lenses was recorded on a questionnaire as a numerical rating on a scale of 1 to 100, with 1 being completely dissatisfied, and 100 being excellent, completely satisfied.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2012.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lotrafilcon B multifocal contact lens, lotrafilcon B single vision contact lens and Over-reader spectacles in people with Presbyopia, run by CIBA VISION at 1 site in Canada.
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 4 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 10 Jul 2012. 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 Canada. 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 14 Mar 2011). 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?
Overall Satisfaction With the Lenses (time frame: 1 week of wear). 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 10 Jul 2012.