ComfortNCT00659815
Performance of Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution in a New Packaging Configuration
A study testing Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in the Currently Marketed Resin Bottle. and Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in a Clear Resin Bottle. in people with Comfort, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
The objective of the study is to evaluate the product performance of Bausch \& Lomb ReNu MultiPlus Multi-Purpose Solution in a new packaging configuration Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Comfort
- What is being tested?
- Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in the Currently Marketed Resin Bottle. and Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in a Clear Resin Bottle.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to May 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is a habitual wearer of planned replacement soft contact lenses
- VA correctable to 0.3 LogMar or better (driving vision)
- Clear central cornea
- Subject uses a lens care system on a regular basis
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
1 site in 1 country.
About this study
Official title: Performance of Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution in a Clear Polyethylene Terephthalate (PET) Bottle.
The objective of the study is to evaluate the product performance of Bausch \& Lomb ReNu MultiPlus Multi-Purpose Solution in a new packaging configuration
- Conditions
- Comfort
- Being tested
- Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in the Currently Marketed Resin Bottle., Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in a Clear Resin Bottle.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in the Currently Marketed Resin Bottle.Device
Daily care for contact lenses.
Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in a Clear Resin Bottle.Device
Daily care for contact lenses
| Study group | Role | What they receive |
|---|---|---|
| ReNu in Currently Marketed Bottle | Active comparator | Bausch \& Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in the Currently Marketed Resin Bottle. Receives: Device: Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in the Currently Marketed Resin Bottle. |
| ReNu in Clear Resin Bottle | Experimental | Bausch \& Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in a Clear Resin Bottle. Receives: Device: Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in a Clear Resin Bottle. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort
Non-inferiority assessment of symptoms/complaints to rate solution comfort. Measurement based on 0-100 scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable rating.
Measured: Over-all follow-up visits from baseline to 1 month
Slit Lamp Findings
Graded 0-4 where Grade 0=none; Grade 1=Trace; Grade 2=Mild; Grade 3=Moderate; Grade 4=Severe.
Measured: Over-all follow-up visits from baseline to1 month
Lens Deposits
Lens Deposits (All Eligible, Dispensed Eyes) Absent = deposit ratings of none or light; Present = deposit ratings of medium or heavy.
Measured: Over-all study visits, baseline to 1-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionMay 2008
- Study completionMay 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 ComfortStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerard Cairns, PhD, MCOptom, Study director, Bausch & Lomb IncorporatedJames Ferrari, OD, Principal investigator, James Ferrari, OD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659815
- Sponsor's protocol ID
- 549
- Status last verified
- Dec 2011
- First submitted
- 12 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
- Performance of Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution in a Clear Polyethylene Terephthalate (PET) Bottle.
- ClinicalTrials.gov ID
- NCT00659815
- Acronym / sponsor ID
- 549
- Conditions
- Comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 16 Apr 2008 (estimated)
- Results
- Posted 15 Nov 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 the study is to evaluate the product performance of Bausch \& Lomb ReNu MultiPlus Multi-Purpose Solution in a new packaging configuration
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ReNu in Currently Marketed Bottle | Active comparator | Device: Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in the Currently Marketed Resin Bottle.Bausch \& Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in the Currently Marketed Resin Bottle. |
| ReNu in Clear Resin Bottle | Experimental | Device: Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in a Clear Resin Bottle.Bausch \& Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in a Clear Resin Bottle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is a habitual wearer of planned replacement soft contact lenses
- VA correctable to 0.3 LogMar or better (driving vision)
- Clear central cornea
- Subject uses a lens care system on a regular basis
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 |
|---|---|---|
| Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in the Currently Marketed Resin Bottle.Daily care for contact lenses. | Device | ReNu in Currently Marketed Bottle |
| Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in a Clear Resin Bottle.Daily care for contact lenses | Device | ReNu in Clear Resin Bottle |
Primary outcome
Comfort
Time frame: Over-all follow-up visits from baseline to 1 month
Non-inferiority assessment of symptoms/complaints to rate solution comfort. Measurement based on 0-100 scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable rating.
Slit Lamp Findings
Time frame: Over-all follow-up visits from baseline to1 month
Graded 0-4 where Grade 0=none; Grade 1=Trace; Grade 2=Mild; Grade 3=Moderate; Grade 4=Severe.
Lens Deposits
Time frame: Over-all study visits, baseline to 1-month
Lens Deposits (All Eligible, Dispensed Eyes) Absent = deposit ratings of none or light; Present = deposit ratings of medium or heavy.
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, PhD, MCOptom study director
Bausch & Lomb Incorporated
James Ferrari, OD principal investigator
James Ferrari, OD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in the Currently Marketed Resin Bottle. and Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in a Clear Resin Bottle. in people with Comfort, 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 4 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 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 15 Nov 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?
Comfort (time frame: Over-all follow-up visits from baseline to 1 month). The study lists 3 primary outcomes in all. 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.