Adverse Effect of Contact Lens SolutionNCT00636194
Comparative Performance of a Bausch & Lomb Multipurpose Solution and Alcon OptiFree Replenish Multipurpose Solution
A study testing Bausch & Lomb Multipurpose Solution and Alcon OptiFree Replenish Multipurpose Solution in people with Adverse Effect of Contact Lens Solution, run by Bausch & Lomb Incorporated at 1 site in Malaysia.
Trial summary
To evaluate the product performance of a Bausch \& Lomb Multipurpose solution when compared to Alcon OptiFree Replenish Multipurpose Solution Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adverse Effect of Contact Lens Solution
- What is being tested?
- Bausch & Lomb Multipurpose Solution and Alcon OptiFree Replenish Multipurpose Solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 361 participants
- Where
- 1 siteMalaysia
- Study dates
- Feb 2008to Apr 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
- Subjects are adapted wearers of silicone hydrogel 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 a monovision, multifocal or toric contact lenses
- Any grade 2 or greater slit lamp findings
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Laser Focus Sdn Bhd, Vision Correction Centre
Jalan Kuning, Tamn Pelangi, Johor Bahru, 80400
About this study
Official title: Product Performance of Bausch & Lomb Multi-Purpose Solution Compared to Alcon Opti-Free Replenish Multi-Purpose Solution When Used With Silicone Hydrogel Contact Lenses Worn on a Daily Wear Basis
To evaluate the product performance of a Bausch \& Lomb Multipurpose solution when compared to Alcon OptiFree Replenish Multipurpose Solution
- Conditions
- Adverse Effect of Contact Lens Solution
- Being tested
- Bausch & Lomb Multipurpose Solution, Alcon OptiFree Replenish Multipurpose Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bausch & Lomb Multipurpose SolutionDevice
daily care of contact lenses
Alcon OptiFree Replenish Multipurpose SolutionDevice
daily care for contact lenses
| Study group | Role | What they receive |
|---|---|---|
| B&L Multipurpose solution | Experimental | Bausch \& Lomb Multipurpose Contact Lens Solution Receives: Device: Bausch & Lomb Multipurpose Solution |
| Alcon Multipurpose Solution | Active comparator | Alcon OptiFree Replenish Multipurpose Contact Lens Solution Receives: Device: Alcon OptiFree Replenish Multipurpose Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Assessment of Comfort and Cleanliness
Scale from 0-100 for each eye where 100=most favorable rating and 0=the least favorable rating.
Measured: 7 days
Secondary outcomes (2)
Symptoms and Complaints
Scores on a scale from 0 to 100, with 100 being the most favorable. Eyes with multiple unscheduled visits in a visit category were counted once for their lowest score.
Measured: 2 weeks
Graded Slit Lamp Findings > Grade 2
Grade none (no findings) - grade 4 (severe findings). Eyes in the Test group were compared with eyes in the Control group. Slit lamp finding greater than Grade 2.
Measured: 2 week follow-up visit
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 startFeb 2008
- Primary completionMar 2008
- Study completionApr 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 Adverse Effect of Contact Lens SolutionStudies 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
- 361 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
- NCT00636194
- Sponsor's protocol ID
- 562
- Status last verified
- Dec 2011
- First submitted
- 7 Mar 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
- Product Performance of Bausch & Lomb Multi-Purpose Solution Compared to Alcon Opti-Free Replenish Multi-Purpose Solution When Used With Silicone Hydrogel Contact Lenses Worn on a Daily Wear Basis
- ClinicalTrials.gov ID
- NCT00636194
- Acronym / sponsor ID
- 562
- Conditions
- Adverse Effect of Contact Lens Solution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Mar 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 14 Mar 2008 (estimated)
- Results
- Posted 15 Feb 2011
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 product performance of a Bausch \& Lomb Multipurpose solution when compared to Alcon OptiFree Replenish Multipurpose Solution
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B&L Multipurpose solution | Experimental | Device: Bausch & Lomb Multipurpose SolutionBausch \& Lomb Multipurpose Contact Lens Solution |
| Alcon Multipurpose Solution | Active comparator | Device: Alcon OptiFree Replenish Multipurpose SolutionAlcon OptiFree Replenish Multipurpose Contact Lens Solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects are adapted wearers of silicone hydrogel 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 a 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 Solutiondaily care of contact lenses | Device | B&L Multipurpose solution |
| Alcon OptiFree Replenish Multipurpose Solutiondaily care for contact lenses | Device | Alcon Multipurpose Solution |
Primary outcome
Subjective Assessment of Comfort and Cleanliness
Time frame: 7 days
Scale from 0-100 for each eye where 100=most favorable rating and 0=the least favorable rating.
2 secondary outcomes
Symptoms and Complaints
Time frame: 2 weeks
Graded Slit Lamp Findings > Grade 2
Time frame: 2 week follow-up visit
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.
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 and Alcon OptiFree Replenish Multipurpose Solution in people with Adverse Effect of Contact Lens Solution, run by Bausch & Lomb Incorporated at 1 site in Malaysia.
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 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 Malaysia. 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 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?
Subjective Assessment of Comfort and Cleanliness (time frame: 7 days). 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.