MyopiaNCT00768885
Comparative Study of the Wearing Satisfaction of Two Soft Contact Lens Designs.
A study testing PureVision 1 and PureVision 2 in people with Myopia, run by Bausch & Lomb Incorporated at 1 site in Japan.
Trial summary
To evaluate the wearing satisfaction of a new design of the PureVision soft contact lenses. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- PureVision 1 and PureVision 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2008to Jan 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is myopic
- Subjects who wear soft contact lenses that are exchanged at least biweekly at the time consent is obtained.
Who cannot join
- Systemic disease affecting ocular health
- Using pharmaceuticals that may affect the function of the eyes or lenses.
- Subject possessing corneal infiltrate or corneal ulcers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of the Wearing Satisfaction of Two Soft Contact Lens Designs
To evaluate the wearing satisfaction of a new design of the PureVision soft contact lenses.
- Conditions
- Myopia
- Being tested
- PureVision 1, PureVision 2
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PureVision 1Device
Currently marketed PureVision soft contact lens.
PureVision 2Device
Alternate design soft contact lens.
| Study group | Role | What they receive |
|---|---|---|
| PureVision 1 | Active comparator | PureVision soft contact lens design #1. Receives: Device: PureVision 1 |
| PureVision 2 | Experimental | PureVision soft contact lens design #2 Receives: Device: PureVision 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionOct 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00768885
- Sponsor's protocol ID
- MDPTLD0809
- Status last verified
- Mar 2013
- First submitted
- 6 Oct 2008
- Last updated
- 18 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Wearing Satisfaction of Two Soft Contact Lens Designs
- ClinicalTrials.gov ID
- NCT00768885
- Acronym / sponsor ID
- MDPTLD0809
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 8 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the wearing satisfaction of a new design of the PureVision soft contact lenses.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PureVision 1 | Active comparator | Device: PureVision 1PureVision soft contact lens design #1. |
| PureVision 2 | Experimental | Device: PureVision 2PureVision soft contact lens design #2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject is myopic
- Subjects who wear soft contact lenses that are exchanged at least biweekly at the time consent is obtained.
Key exclusion criteria (3 listed)
- Systemic disease affecting ocular health
- Using pharmaceuticals that may affect the function of the eyes or lenses.
- Subject possessing corneal infiltrate or corneal ulcers.
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 1Currently marketed PureVision soft contact lens. | Device | PureVision 1 |
| PureVision 2Alternate design soft contact lens. | Device | PureVision 2 |
Primary outcome
Patient satisfaction
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2013.
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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 PureVision 1 and PureVision 2 in people with Myopia, run by Bausch & Lomb Incorporated at 1 site in Japan.
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 2 inclusion and 3 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 18 Mar 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 Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient satisfaction (time frame: 4 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 18 Mar 2013.