Vision DisordersNCT01318577
Study of A New Contact Lens Cleaning and Disinfecting Solution
A study testing Investigational Cleaning & Disinfecting Solution and Clear Care Solution in people with Vision Disorders, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
The objective of this study is to evaluate the safety and efficacy of a new investigational cleaning and disinfecting solution (Test) compared to Clear Care cleaning and disinfecting solution (Control) when used by contact lens wearers to clean and disinfect their contact lenses for approximately three months. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vision Disorders
- What is being tested?
- Investigational Cleaning & Disinfecting Solution and Clear Care Solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 444 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Jun 2011
- 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
- Subjects must be habitual wearers of one of the protocol specified lenses.
- Subjects must habitually use a NON-PEROXIDE lens care product for cleaning, disinfecting and storage of their lenses.
- Subjects must be adapted lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand.
- Subjects must agree to wear their lenses on a daily wear basis for approximately three months.
Who cannot join
- Subjects who currently use a hydrogen peroxide cleaning and disinfecting solution.
- Subjects who currently wear Opaque Cosmetic Tint Contact Lenses.
- Subjects who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
- Subjects with any systemic disease currently affecting ocular health or which in the Investigator"s opinion may have an effect on ocular health during the course of the study.
- Subjects using any systemic or topical medications that will, in the Investigator"s opinion, affect ocular physiology or lens performance.
- Subjects with any "Present" finding during the slit lamp examination that, in the Investigator"s judgment, interferes with contact lens wear.
- Subjects with any scar or neovascularization within the central 4 mm of the cornea.
- Subjects who are allergic to any component in the study care products.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bausch & Lomb Incorporated
Rochester, New York, 14609
About this study
The objective of this study is to evaluate the safety and efficacy of a new investigational cleaning and disinfecting solution (Test) compared to Clear Care cleaning and disinfecting solution (Control) when used by contact lens wearers to clean and disinfect their contact lenses for approximately three months.
- Conditions
- Vision Disorders
- Being tested
- Investigational Cleaning & Disinfecting Solution, Clear Care Solution
- Keywords
- Contact lens, Cleaning solution
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Cleaning & Disinfecting SolutionDevice
Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution
Clear Care SolutionDevice
Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution
| Study group | Role | What they receive |
|---|---|---|
| Investigational Solution | Experimental | Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses. Receives: Device: Investigational Cleaning & Disinfecting Solution |
| Clear Care Solution | Active comparator | Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses Receives: Device: Clear Care Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Eyes With > Grade 2 Slit Lamp Findings
Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding > grade 2, across abnormalities.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2011 (estimated)
- Study startNov 2010
- Primary completionApr 2011
- Study completionJun 2011
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 Vision DisordersStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 444 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beverly Barna, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318577
- Sponsor's protocol ID
- 682
- Status last verified
- Oct 2020
- First submitted
- 16 Mar 2011
- Last updated
- 8 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of A New Contact Lens Cleaning and Disinfecting Solution
- ClinicalTrials.gov ID
- NCT01318577
- Acronym / sponsor ID
- 682
- Conditions
- Vision Disorders
- Keywords
- Contact lens, Cleaning solution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 444 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 18 Mar 2011 (estimated)
- Results
- Posted 8 Oct 2020
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 safety and efficacy of a new investigational cleaning and disinfecting solution (Test) compared to Clear Care cleaning and disinfecting solution (Control) when used by contact lens wearers to clean and disinfect their contact lenses for approximately three months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Solution | Experimental | Device: Investigational Cleaning & Disinfecting SolutionHydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses. |
| Clear Care Solution | Active comparator | Device: Clear Care SolutionHydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must be habitual wearers of one of the protocol specified lenses.
- Subjects must habitually use a NON-PEROXIDE lens care product for cleaning, disinfecting and storage of their lenses.
- Subjects must be adapted lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand.
- Subjects must agree to wear their lenses on a daily wear basis for approximately three months.
Key exclusion criteria (8 listed)
- Subjects who currently use a hydrogen peroxide cleaning and disinfecting solution.
- Subjects who currently wear Opaque Cosmetic Tint Contact Lenses.
- Subjects who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
- Subjects with any systemic disease currently affecting ocular health or which in the Investigator"s opinion may have an effect on ocular health during the course of the study.
- Subjects using any systemic or topical medications that will, in the Investigator"s opinion, affect ocular physiology or lens performance.
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 |
|---|---|---|
| Investigational Cleaning & Disinfecting SolutionContact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution | Device | Investigational Solution |
| Clear Care SolutionContact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution | Device | Clear Care Solution |
Primary outcome
Percentage of Eyes With > Grade 2 Slit Lamp Findings
Time frame: 3 months
Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding > grade 2, across abnormalities.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- 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.
Beverly 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 Investigational Cleaning & Disinfecting Solution and Clear Care Solution in people with Vision Disorders, 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 8 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 8 Oct 2020. 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 Oct 2020). 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?
Percentage of Eyes With > Grade 2 Slit Lamp Findings (time frame: 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 8 Oct 2020.