Contact Lens SolutionsNCT00710879
Evaluation of a Multi-Purpose Solution
A study testing Bausch & Lomb Multi-Purpose Solution in people with Contact Lens Solutions, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
This study evaluates a multi-purpose solution when used on a daily wear basis by currently adapted soft contact lens wearers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Contact Lens Solutions
- What is being tested?
- Bausch & Lomb Multi-Purpose Solution
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Feb 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is an adapted Group I or Group IV soft contact lens wearer and agrees to wear the study lenses on a daily wear basis.
- Must be able and willing to comply with all treatment and follow-up study procedures.
- Must have a clear central cornea.
- VA correctable to 0.3 LogMar or better (driving vision)
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.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Clinical Performance of a Multi-Purpose Solution.
This study evaluates a multi-purpose solution when used on a daily wear basis by currently adapted soft contact lens wearers.
- Conditions
- Contact Lens Solutions
- Being tested
- Bausch & Lomb Multi-Purpose Solution
- Keywords
- Efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bausch & Lomb Multi-Purpose SolutionDevice
Daily care for contact lenses.
| Study group | Role | What they receive |
|---|---|---|
| Multipurpose Solution | Experimental | Multi-purpose solution administered to adapted FDA group I soft contact lens wearers and FDA group IV soft contact lens wearers. Receives: Device: Bausch & Lomb Multi-Purpose Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antimicrobial Efficacy
Excellent = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora <0-103 CFU/mL. Good = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora <103-105 CFU/mL. Skeptical = Bacterial infection suspected and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. No Efficacy = Bacterial infection definite and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. Pathogens were H. aegyptius, H. influenzae, Moraxella spp., P. aeruginosa, S. pneumoniae, S. aureus, N. gonorrhoeae
Measured: 2 weeks, 3 months
Secondary outcomes (2)
Solution Related AE's and Lens Changes
Very Safe = No solution related AEs and no changes in lens properties related to the solution. Safe = No solution related AEs and slight change in lens properties related to the solution, but lens wear was continued. Skeptical = Solution related AEs were suspected and lens properties changed due to the solution and lens wear was discontinued. Not Safe = Solution related AEs were present and lens properties changed due to the solution and lens wear was discontinued.
Measured: 3 months, 6 months
Solution Utlility
The Utility was determined based on the results of the efficacy and safety evaluations.
Measured: 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionFeb 2009
- Study completionFeb 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 Contact Lens SolutionsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bev Barna, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00710879
- Sponsor's protocol ID
- 568
- Status last verified
- Dec 2011
- First submitted
- 30 Jun 2008
- Last updated
- 13 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 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Clinical Performance of a Multi-Purpose Solution.
- ClinicalTrials.gov ID
- NCT00710879
- Acronym / sponsor ID
- 568
- Conditions
- Contact Lens Solutions
- Keywords
- Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 8 Jul 2008 (estimated)
- Results
- Posted 8 Feb 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 evaluates a multi-purpose solution when used on a daily wear basis by currently adapted soft contact lens wearers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multipurpose Solution | Experimental | Device: Bausch & Lomb Multi-Purpose SolutionMulti-purpose solution administered to adapted FDA group I soft contact lens wearers and FDA group IV soft contact lens wearers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Is an adapted Group I or Group IV soft contact lens wearer and agrees to wear the study lenses on a daily wear basis.
- Must be able and willing to comply with all treatment and follow-up study procedures.
- Must have a clear central cornea.
- VA correctable to 0.3 LogMar or better (driving vision)
Key exclusion criteria (5 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.
- Pregnancy
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 Multi-Purpose SolutionDaily care for contact lenses. | Device | Multipurpose Solution |
Primary outcome
Antimicrobial Efficacy
Time frame: 2 weeks, 3 months
Excellent = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora <0-103 CFU/mL. Good = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora <103-105 CFU/mL. Skeptical = Bacterial infection suspected and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. No Efficacy = Bacterial infection definite and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. Pathogens were H. aegyptius, H. influenzae, Moraxella spp., P. aeruginosa, S. pneumoniae, S. aureus, N. gonorrhoeae
2 secondary outcomes
Solution Related AE's and Lens Changes
Time frame: 3 months, 6 months
Solution Utlility
Time frame: 3 months, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 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.
Bev 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 Bausch & Lomb Multi-Purpose Solution in people with Contact Lens Solutions, 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 5 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 13 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 8 Feb 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?
Antimicrobial Efficacy (time frame: 2 weeks, 3 months). 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 13 Dec 2011.