MyopiaNCT01416142
A Study to Evaluate the Product Performance of the PureVision®2 High Definition (HD) Contact Lens
A study testing PureVision2 HD contact lenses and Spectacles in people with Myopia, 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 PureVision2 HD contact lenses. Read more about this study
- Who is it for?
- Ages 15 to 30 years
- Conditions the study is for
- Myopia
- What is being tested?
- PureVision2 HD contact lenses and Spectacles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Sep 2011
- 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 15 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings
- Subjects must be myopic or hyperopic and require lens correction in each eye
- Subjects must own a pair of spectacles and the spectacle prescription must have been updated or confirmed as correct within the last 2 years.
Who cannot join
- Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- 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 Biotrue multi-purpose solution
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Product Performance of the PureVision®2 HD Contact Lens
The objective of this study is to evaluate the product performance of PureVision2 HD contact lenses.
- Conditions
- Myopia
- Being tested
- PureVision2 HD contact lenses, Spectacles
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PureVision2 HD contact lensesDevice
Lenses to be worn through 1/2 of an HD movie. Following the movie, all subjects were to wear the dispensed contact lenses on a daily wear basis for approximately one week.
SpectaclesDevice
Spectacles to be worn throughout 1/2 of an HD movie.
| Study group | Role | What they receive |
|---|---|---|
| Spectacles | Active comparator | The subject's habitual spectacles (updated or confirmed as correct within the last 2 years) Receives: Device: Spectacles |
| PureVision2 HD contact lenses | Experimental | Currently marketed Bausch + Lomb PureVision2 HD contact lenses Receives: Device: PureVision2 HD contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Visual acuity(VA) measured at the screening visit (all eligible participants) while wearing spectacles and the VA measured at the end of study (Visit 3) 1-Week wearing PureVision2 HD lenses. VA wearing spectacles vs. VA wearing PureVision2 HD Lenses, lower the number the better the VA.
Measured: Screening visit (Visit 1) and one week follow-up(Visit 3)
Secondary outcomes (1)
Preference for Test Lens
Proportion of participants preferring the Test lens over their spectacles. Participants changed from Spectacles to PureVision Lenses or PureVision Lenses to spectacles during movie intermission.
Measured: During the movie (Visit 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionAug 2011
- Study completionSep 2011
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 MyopiaStudies 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bev Barna, CCRA, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416142
- Sponsor's protocol ID
- 701E
- Status last verified
- Nov 2013
- First submitted
- 11 Aug 2011
- Last updated
- 25 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Product Performance of the PureVision®2 HD Contact Lens
- ClinicalTrials.gov ID
- NCT01416142
- Acronym / sponsor ID
- 701E
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 12 Aug 2011 (estimated)
- Results
- Posted 25 Dec 2013
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 PureVision2 HD contact lenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spectacles | Active comparator | Device: SpectaclesThe subject's habitual spectacles (updated or confirmed as correct within the last 2 years) |
| PureVision2 HD contact lenses | Experimental | Device: PureVision2 HD contact lensesCurrently marketed Bausch + Lomb PureVision2 HD contact lenses |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings
- Subjects must be myopic or hyperopic and require lens correction in each eye
- Subjects must own a pair of spectacles and the spectacle prescription must have been updated or confirmed as correct within the last 2 years.
Key exclusion criteria (4 listed)
- Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- 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 Biotrue multi-purpose solution
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 |
|---|---|---|
| PureVision2 HD contact lensesLenses to be worn through 1/2 of an HD movie. Following the movie, all subjects were to wear the dispensed contact lenses on a daily wear basis for approximately one week. | Device | PureVision2 HD contact lenses |
| SpectaclesSpectacles to be worn throughout 1/2 of an HD movie. | Device | Spectacles |
Primary outcome
Visual Acuity
Time frame: Screening visit (Visit 1) and one week follow-up(Visit 3)
Visual acuity(VA) measured at the screening visit (all eligible participants) while wearing spectacles and the VA measured at the end of study (Visit 3) 1-Week wearing PureVision2 HD lenses. VA wearing spectacles vs. VA wearing PureVision2 HD Lenses, lower the number the better the VA.
1 secondary outcome
Preference for Test Lens
Time frame: During the movie (Visit 2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2013.
- 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.
Bev 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 PureVision2 HD contact lenses and Spectacles in people with Myopia, 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 25 Dec 2013. 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 25 Dec 2013). 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: Screening visit (Visit 1) and one week follow-up(Visit 3)). 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 25 Dec 2013.