MyopiaPhase 3NCT00661687
Comparative Performance of PureVision Lens Designs
A Phase 3 study testing Currently Marketed PureVision Contact Lens. and Alternate Design of the PureVision Contact Lens. in people with Myopia, run by Bausch & Lomb Incorporated at 2 sites in 2 countries.
Trial summary
The objective of this study is to evaluate the performance of the PureVision Lens designs when worn on a 30-day continuous wear basis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- Currently Marketed PureVision Contact Lens. and Alternate Design of the PureVision Contact Lens.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2007to Jun 2008
- Phase
- Phase 3
- 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
- subject is myopic
- VA correctable to 0.3 logMAR or better (driving vision)
- Clear central cornea
Who cannot join
- Systemic disease affecting ocular health
- using systemic or topical medications
- wear monovision, multifocal or toric contact lenses
- Any grade 2 or greater slit lamp findings
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Malaysia1 site
Laser Focus Sdn Bhd, Vision Correction Centre
Johor Bahru, Johor Bahru, 80400
About this study
Official title: A Study to Evaluate the Product Performance of the Redesigned Bausch & Lomb PureVision® Contact Lens (Test) Compared to the Currently Marketed Bausch & Lomb PureVision® Contact Lens (Control) When Worn on an Extended Wear Basis.
The objective of this study is to evaluate the performance of the PureVision Lens designs when worn on a 30-day continuous wear basis
- Conditions
- Myopia
- Being tested
- Currently Marketed PureVision Contact Lens., Alternate Design of the PureVision Contact Lens.
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Currently Marketed PureVision Contact Lens.Device
Contact lens for continuous wear
Alternate Design of the PureVision Contact Lens.Device
Contact lens for continuous wear
| Study group | Role | What they receive |
|---|---|---|
| Purevision Contact Lens #1 | Active comparator | PureVision Soft Contact Lens Design (currently marketed) Receives: Device: Currently Marketed PureVision Contact Lens. |
| PureVision Contact Lens #2 | Experimental | Redesign of the currently marketed PureVision soft contact lens. Receives: Device: Alternate Design of the PureVision Contact Lens. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Responses to Symptoms/Complaints
Subjective responses to symptoms/complaints on a scale 0-100, where 100 is the most favorable score. Subjects rated various aspects of lens comfort, vision, and handling. The average of each symptom/complaint over all follow-up visits was assessed as the primary endpoint.
Measured: Measured at screening/dispensing visit, 1 day, 1 week and 1 month follow-up visits
Secondary outcomes (2)
LogMAR Visual Acuity
The mean distance high contrast LogMAR visual acuity (VA) score for test eyes over all visits, determined by the total number of letters correctly identified on the logMAR chart.
Measured: Mean over all visits - 1 day, 1 week, 1 month
Lens Characteristics
Investigators evaluated study lenses, while on eye, for the number of eyes showing 100% wettability, no discoloration, none-light deposits, fully centered centration, and adequate movement.
Measured: Over all scheduled visits day 1 - 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study startDec 2007
- Primary completionFeb 2008
- Study completionJun 2008
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerard Cairns, MCOptom, PhD, Study director, Bausch & Lomb IncorporatedBenny Chian, MCOptom, Principal investigator, Laser Focus Sdn Bhd, Vision Correction CentreHarvey Siy Uy, MD, Principal investigator, Asian Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661687
- Sponsor's protocol ID
- 544
- Status last verified
- Dec 2011
- First submitted
- 16 Apr 2008
- Last updated
- 12 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Product Performance of the Redesigned Bausch & Lomb PureVision® Contact Lens (Test) Compared to the Currently Marketed Bausch & Lomb PureVision® Contact Lens (Control) When Worn on an Extended Wear Basis.
- ClinicalTrials.gov ID
- NCT00661687
- Acronym / sponsor ID
- 544
- Conditions
- Myopia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 18 Apr 2008 (estimated)
- Results
- Posted 15 Oct 2010
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 performance of the PureVision Lens designs when worn on a 30-day continuous wear basis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Purevision Contact Lens #1 | Active comparator | Device: Currently Marketed PureVision Contact Lens.PureVision Soft Contact Lens Design (currently marketed) |
| PureVision Contact Lens #2 | Experimental | Device: Alternate Design of the PureVision Contact Lens.Redesign of the currently marketed PureVision soft contact lens. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- subject is myopic
- VA correctable to 0.3 logMAR or better (driving vision)
- Clear central cornea
Key exclusion criteria (4 listed)
- Systemic disease affecting ocular health
- using systemic or topical medications
- wear monovision, multifocal or toric contact lenses
- Any grade 2 or greater slit lamp findings
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 |
|---|---|---|
| Currently Marketed PureVision Contact Lens.Contact lens for continuous wear | Device | Purevision Contact Lens #1 |
| Alternate Design of the PureVision Contact Lens.Contact lens for continuous wear | Device | PureVision Contact Lens #2 |
Primary outcome
Subjective Responses to Symptoms/Complaints
Time frame: Measured at screening/dispensing visit, 1 day, 1 week and 1 month follow-up visits
Subjective responses to symptoms/complaints on a scale 0-100, where 100 is the most favorable score. Subjects rated various aspects of lens comfort, vision, and handling. The average of each symptom/complaint over all follow-up visits was assessed as the primary endpoint.
2 secondary outcomes
LogMAR Visual Acuity
Time frame: Mean over all visits - 1 day, 1 week, 1 month
Lens Characteristics
Time frame: Over all scheduled visits day 1 - 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2011.
- 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.
Gerard Cairns, MCOptom, PhD study director
Bausch & Lomb Incorporated
Benny Chian, MCOptom principal investigator
Laser Focus Sdn Bhd, Vision Correction Centre
Harvey Siy Uy, MD principal investigator
Asian Eye Institute
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Currently Marketed PureVision Contact Lens. and Alternate Design of the PureVision Contact Lens. in people with Myopia, run by Bausch & Lomb Incorporated at 2 sites in 2 countries.
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 12 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malaysia, Philippines. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2010). 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?
Subjective Responses to Symptoms/Complaints (time frame: Measured at screening/dispensing visit, 1 day, 1 week and 1 month follow-up visits). 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 12 Dec 2011.