Contact Lens SolutionsNCT00636363
Safety and Efficacy of a Bausch & Lomb Multipurpose Solution When Compared to Ciba Vision Aquify Multipurpose Solution
A study testing Bausch & Lomb Multipurpose Solution - Rub Care, Bausch & Lomb Multipurpose Solution - No Rub Care and Ciba Vision Aquify Multipurpose Solution in people with Contact Lens Solutions, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
To the safety and efficacy of a Bausch \& Lomb Multipurpose Solution when compared to Ciba vision Aquify Multipurpose solution Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contact Lens Solutions
- What is being tested?
- Bausch & Lomb Multipurpose Solution - Rub Care, Bausch & Lomb Multipurpose Solution - No Rub Care and Ciba Vision Aquify Multipurpose Solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 541 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Aug 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 a silicone hydrogel or group IV contact lens
- 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
To the safety and efficacy of a Bausch \& Lomb Multipurpose Solution when compared to Ciba vision Aquify Multipurpose solution
- Conditions
- Contact Lens Solutions
- Being tested
- Bausch & Lomb Multipurpose Solution - Rub Care, Bausch & Lomb Multipurpose Solution - No Rub Care, Ciba Vision Aquify Multipurpose Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bausch & Lomb Multipurpose Solution - Rub CareDevice
Daily care for contact lenses - rub care regimen
Bausch & Lomb Multipurpose Solution - No Rub CareDevice
Daily care for contact lenses - no rub care regimen
Ciba Vision Aquify Multipurpose SolutionDevice
daily care for contact lenses
| Study group | Role | What they receive |
|---|---|---|
| Multipurpose Solution - Rub Care | Experimental | Bausch \& Lomb Multipurpose Solution for use with contact lens care Receives: Device: Bausch & Lomb Multipurpose Solution - Rub Care |
| Multipurpose Solution - No Rub Care | Experimental | Bausch \& Lomb Multipurpose Solution for use with contact lens care Receives: Device: Bausch & Lomb Multipurpose Solution - No Rub Care |
| Ciba Vision Aquify Multipurpose Solution | Active comparator | Ciba Vision Aquify Multipurpose Solution for use with contact lens care Receives: Device: Ciba Vision Aquify Multipurpose Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slit-lamp Findings > Grade 2
eyes with any slit lamp findings greater than Grade 2 at any visit. Slit lamp findings for each eye will be graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates will be assessed.
Measured: Over 4 visits for 3 month period
Subjective Responses to Comfort Related Symptoms/Complaints
Subject symptoms/complaints will be assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.
Measured: Over 4 visits for the 3 month period
Contact Lens Deposits
Lens deposits assessed at each follow-up visit. Degree of deposits assessed as none, light, medium, or heavy.
Measured: At each visit for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionAug 2008
- Study completionAug 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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 541 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohinder Merchea, OD, PhD, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636363
- Sponsor's protocol ID
- 554
- Status last verified
- Mar 2015
- First submitted
- 7 Mar 2008
- Last updated
- 24 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of a Bausch & Lomb Multipurpose Solution When Compared to Ciba Vision Aquify Multipurpose Solution
- ClinicalTrials.gov ID
- NCT00636363
- Acronym / sponsor ID
- 554
- Conditions
- Contact Lens Solutions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 541 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 14 Mar 2008 (estimated)
- Results
- Posted 8 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To the safety and efficacy of a Bausch \& Lomb Multipurpose Solution when compared to Ciba vision Aquify Multipurpose solution
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multipurpose Solution - Rub Care | Experimental | Device: Bausch & Lomb Multipurpose Solution - Rub CareBausch \& Lomb Multipurpose Solution for use with contact lens care |
| Multipurpose Solution - No Rub Care | Experimental | Device: Bausch & Lomb Multipurpose Solution - No Rub CareBausch \& Lomb Multipurpose Solution for use with contact lens care |
| Ciba Vision Aquify Multipurpose Solution | Active comparator | Device: Ciba Vision Aquify Multipurpose SolutionCiba Vision Aquify Multipurpose Solution for use with contact lens care |
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 a silicone hydrogel or group IV contact lens
- 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 Multipurpose Solution - Rub CareDaily care for contact lenses - rub care regimen | Device | Multipurpose Solution - Rub Care |
| Bausch & Lomb Multipurpose Solution - No Rub CareDaily care for contact lenses - no rub care regimen | Device | Multipurpose Solution - No Rub Care |
| Ciba Vision Aquify Multipurpose Solutiondaily care for contact lenses | Device | Ciba Vision Aquify Multipurpose Solution |
Primary outcome
Slit-lamp Findings > Grade 2
Time frame: Over 4 visits for 3 month period
eyes with any slit lamp findings greater than Grade 2 at any visit. Slit lamp findings for each eye will be graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates will be assessed.
Subjective Responses to Comfort Related Symptoms/Complaints
Time frame: Over 4 visits for the 3 month period
Subject symptoms/complaints will be assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.
Contact Lens Deposits
Time frame: At each visit for 3 months
Lens deposits assessed at each follow-up visit. Degree of deposits assessed as none, light, medium, or heavy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
- 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.
Mohinder Merchea, OD, PhD 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 Multipurpose Solution - Rub Care, Bausch & Lomb Multipurpose Solution - No Rub Care and Ciba Vision Aquify Multipurpose 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 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 24 Mar 2015. 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 Apr 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?
Slit-lamp Findings > Grade 2 (time frame: Over 4 visits for 3 month period). 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 24 Mar 2015.