Ocular DiscomfortNCT01024751
A Study to Evaluate the Clinical Performance of a Novel Multipurpose Solution
A study testing Bausch & Lomb Multi-Purpose Solution and Ciba's Multi-Purpose Solution in people with Ocular Discomfort, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
The objective of this study is to evaluate the clinical performance of Bausch \& Lomb investigational Multi-Purpose Solution compared to Ciba Vision Multi-Purpose Solution when used by wearers of silicone hydrogel or Group IV contact lenses. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ocular Discomfort
- What is being tested?
- Bausch & Lomb Multi-Purpose Solution and Ciba's Multi-Purpose Solution
- 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
- Nov 2009to Feb 2010
- 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
- Participants must be of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed and with the capacity to provide voluntary informed consent.
- Participants must habitually use a lens care product for lens cleaning, disinfecting, and storage.
- Participants must wear a lens in each eye and each lens must be of the same manufacture and brand.
- Participants must agree to wear study lenses on a daily wear basis.
- Participants must be able and willing to comply with all treatment and follow-up/study procedures.
Who cannot join
- Participants participating in any drug or device clinical investigation within 2 weeks prior to entry into this study and/or during the period of study participation.
- Participants with any systemic disease affecting ocular health.
- Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- Participants who have had any corneal surgery (eg, refractive surgery).
- Participants who are allergic to any component in the study care products.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to evaluate the clinical performance of Bausch \& Lomb investigational Multi-Purpose Solution compared to Ciba Vision Multi-Purpose Solution when used by wearers of silicone hydrogel or Group IV contact lenses.
- Conditions
- Ocular Discomfort
- Being tested
- Bausch & Lomb Multi-Purpose Solution, Ciba's Multi-Purpose Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bausch & Lomb Multi-Purpose SolutionDevice
Lens care product for disinfecting lenses on a daily basis.
Ciba's Multi-Purpose SolutionDevice
Lens care product for disinfecting lenses on a daily basis.
| Study group | Role | What they receive |
|---|---|---|
| Bausch & Lomb Multi-Purpose Solution | Experimental | Multi-Purpose Solution to be used for disinfecting contact lenses. Receives: Device: Bausch & Lomb Multi-Purpose Solution |
| Ciba's Multi-Purpose Solution | Active comparator | Multi-Purpose Solution to be used for disinfecting contact lenses. Receives: Device: Ciba's Multi-Purpose Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort-related Symptoms/Complaints
Participants rated their subjective symptoms/complaints using a 0 to 100 scale for each eye. A 0 represented the least favorable rating, and a 100 represented the most favorable rating. Over All Follow-Up Visits summarizes the average over all follow-up visit summaries.
Measured: At dispensing visit and each follow-up visit at week 2 and week 4.
Secondary outcomes (1)
Slit Lamp Findings
Graded slit lamp findings for each eye greater than grade 2 included epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates. Slit lamp findings are grade on a scale of 0-4 with 0=none and 4=severe. Over All Follow-up Visits summarizes the worst case over all follow-up visits.
Measured: Over all visits for 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionJan 2010
- Study completionFeb 2010
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 Ocular DiscomfortStudies 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)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024751
- Sponsor's protocol ID
- 636
- Status last verified
- Jul 2011
- First submitted
- 30 Nov 2009
- Last updated
- 15 Aug 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 15 Aug 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 Novel Multipurpose Solution
- ClinicalTrials.gov ID
- NCT01024751
- Acronym / sponsor ID
- 636
- Conditions
- Ocular Discomfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 3 Dec 2009 (estimated)
- Results
- Posted 11 Aug 2011
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 clinical performance of Bausch \& Lomb investigational Multi-Purpose Solution compared to Ciba Vision Multi-Purpose Solution when used by wearers of silicone hydrogel or Group IV contact lenses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bausch & Lomb Multi-Purpose Solution | Experimental | Device: Bausch & Lomb Multi-Purpose SolutionMulti-Purpose Solution to be used for disinfecting contact lenses. |
| Ciba's Multi-Purpose Solution | Active comparator | Device: Ciba's Multi-Purpose SolutionMulti-Purpose Solution to be used for disinfecting contact lenses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must be of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed and with the capacity to provide voluntary informed consent.
- Participants must habitually use a lens care product for lens cleaning, disinfecting, and storage.
- Participants must wear a lens in each eye and each lens must be of the same manufacture and brand.
- Participants must agree to wear study lenses on a daily wear basis.
- Participants must be able and willing to comply with all treatment and follow-up/study procedures.
Key exclusion criteria (5 listed)
- Participants participating in any drug or device clinical investigation within 2 weeks prior to entry into this study and/or during the period of study participation.
- Participants with any systemic disease affecting ocular health.
- Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- Participants who have had any corneal surgery (eg, refractive surgery).
- Participants who are allergic to any component in the study care products.
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 SolutionLens care product for disinfecting lenses on a daily basis. | Device | Bausch & Lomb Multi-Purpose Solution |
| Ciba's Multi-Purpose SolutionLens care product for disinfecting lenses on a daily basis. | Device | Ciba's Multi-Purpose Solution |
Primary outcome
Comfort-related Symptoms/Complaints
Time frame: At dispensing visit and each follow-up visit at week 2 and week 4.
Participants rated their subjective symptoms/complaints using a 0 to 100 scale for each eye. A 0 represented the least favorable rating, and a 100 represented the most favorable rating. Over All Follow-Up Visits summarizes the average over all follow-up visit summaries.
1 secondary outcome
Slit Lamp Findings
Time frame: Over all visits for 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Ciba's Multi-Purpose Solution in people with Ocular Discomfort, 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 5 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 15 Aug 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 11 Aug 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?
Comfort-related Symptoms/Complaints (time frame: At dispensing visit and each follow-up visit at week 2 and week 4.). 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 15 Aug 2011.