Vision DisordersNCT00985231
Performance Evaluation of Contact Lenses Among a Population of Adapted Contact Lens Wearers
A study testing PureVision Multi-Focal contact lenses and SofLens59 contact lens in people with Vision Disorders, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
This study is being conducted to evaluate Bausch \& Lomb PureVision Multi-Focal contact lenses compared to the Bausch \& Lomb SofLens59 contact lens when worn by adapted soft contact lens wearers on a daily wear basis. Read more about this study
- Who is it for?
- Ages 30 to 40 years
- Conditions the study is for
- Vision Disorders
- What is being tested?
- PureVision Multi-Focal contact lenses and SofLens59 contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 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 30 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects must have clear central corneas and be free of any anterior segment disorders.
- Subjects must be adapted soft contact lens wearers and agree to wear the study lenses on a daily wear basis for at least eight hours a day for approximately two weeks.
- Subjects must wear a lens in each eye and each lens must be of the same manufacture and brand.
Who cannot join
- Subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.
- Subjects with any systemic disease affecting ocular health
- Subjects with an active ocular disease or using any ocular medication.
- Subjects who have had any corneal surgery (eg, refractive surgery).
Trial locations and contacts
1 site in 1 country.
About this study
This study is being conducted to evaluate Bausch \& Lomb PureVision Multi-Focal contact lenses compared to the Bausch \& Lomb SofLens59 contact lens when worn by adapted soft contact lens wearers on a daily wear basis.
- Conditions
- Vision Disorders
- Being tested
- PureVision Multi-Focal contact lenses, SofLens59 contact lens
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PureVision Multi-Focal contact lensesDevice
Contact lenses to be worn on a daily wear basis for 2 weeks.
SofLens59 contact lensDevice
Contact lenses to be worn on a daily wear basis for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| PureVision Multi-Focal contact lenses | Experimental | Not described Receives: Device: PureVision Multi-Focal contact lenses |
| SofLens59 contact lens | Active comparator | Not described Receives: Device: SofLens59 contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance Visual Acuity (VA) Between Test and Control Lenses Worse Than 20/40.
Eyes with distance lens VA of 20/40 or worse at study exit between test and control lenses.
Measured: 2 weeks
Secondary outcomes (1)
Subjective Ratings of Eye Strain
Convergence Insufficiency Symptom Survey (CISS), was used to assess eye strain symptoms measured on a scale of 1-4. 0 score=never, 4 score=always
Measured: 2 week visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionNov 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 Vision DisordersStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beverly J Barna, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985231
- Sponsor's protocol ID
- 630
- Status last verified
- Mar 2015
- First submitted
- 25 Sep 2009
- Last updated
- 24 Mar 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 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation of Contact Lenses Among a Population of Adapted Contact Lens Wearers
- ClinicalTrials.gov ID
- NCT00985231
- Acronym / sponsor ID
- 630
- Conditions
- Vision Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 28 Sep 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.
This study is being conducted to evaluate Bausch \& Lomb PureVision Multi-Focal contact lenses compared to the Bausch \& Lomb SofLens59 contact lens when worn by adapted soft contact lens wearers on a daily wear basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PureVision Multi-Focal contact lenses | Experimental | Device: PureVision Multi-Focal contact lenses |
| SofLens59 contact lens | Active comparator | Device: SofLens59 contact lens |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects must have clear central corneas and be free of any anterior segment disorders.
- Subjects must be adapted soft contact lens wearers and agree to wear the study lenses on a daily wear basis for at least eight hours a day for approximately two weeks.
- Subjects must wear a lens in each eye and each lens must be of the same manufacture and brand.
Key exclusion criteria (4 listed)
- Subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.
- Subjects with any systemic disease affecting ocular health
- Subjects with an active ocular disease or using any ocular medication.
- Subjects who have had any corneal surgery (eg, refractive surgery).
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 |
|---|---|---|
| PureVision Multi-Focal contact lensesContact lenses to be worn on a daily wear basis for 2 weeks. | Device | PureVision Multi-Focal contact lenses |
| SofLens59 contact lensContact lenses to be worn on a daily wear basis for 2 weeks. | Device | SofLens59 contact lens |
Primary outcome
Distance Visual Acuity (VA) Between Test and Control Lenses Worse Than 20/40.
Time frame: 2 weeks
Eyes with distance lens VA of 20/40 or worse at study exit between test and control lenses.
1 secondary outcome
Subjective Ratings of Eye Strain
Time frame: 2 week visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 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.
Beverly J Barna 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 PureVision Multi-Focal contact lenses and SofLens59 contact lens in people with Vision Disorders, 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 3 inclusion and 4 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 24 Mar 2015. 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 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?
Distance Visual Acuity (VA) Between Test and Control Lenses Worse Than 20/40. (time frame: 2 weeks). 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 24 Mar 2015.