Contact LensesNCT00982046
A Clinical Comparison of Three Contact Lens Care Systems and Their Effect on Contact Lenses
A study testing Opti-Free RepleniSH multi-purpose disinfecting solution, ReNu MultiPlus multi-purpose solution and Clear Care cleaning and disinfecting system in people with Contact Lenses, run by Alcon Research at 1 site in United Kingdom.
Trial summary
The purpose of this study was to evaluate the clinical performance of three differing contact lens care solutions when used in conjunction with three contact lenses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contact Lenses
- What is being tested?
- Opti-Free RepleniSH multi-purpose disinfecting solution, ReNu MultiPlus multi-purpose solution and Clear Care cleaning and disinfecting system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2009to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Signed informed consent.
- Adapted contact lens wearer for at least one month.
- Spherical prescription range between +6.00 to -8.00 diopters.
- Astigmatism of less than or equal to 1.00 diopter in at least one eye.
- Normal eyes with no evidence of abnormality or disease.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Rigid Gas Permeable (RGP) contact lens wear in last 30 days.
- Concurrent ocular medication, systemic illness, or medical treatment that will affect ocular physiology, lens performance, or vision.
- Corneal infiltrates, scarring, or neovascularization within central 4 millimeters of cornea.
- Eye injury or surgery within 8 weeks prior to study.
- Aphakia, amblyopia, abnormal lacrimal secretions, ocular irritation, keratoconus, corneal irregularity, pregnancy, lactating, planning to become pregnant during the study, and participation in a concurrent clinical trial.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to evaluate the clinical performance of three differing contact lens care solutions when used in conjunction with three contact lenses.
Read the detailed description
This study was conducted as three separate studies based on the contact lens brand dispensed. In each study, the contact lens was evaluated in conjunction with three solutions: Opti-Free Replenish, ReNu MultiPlus, and Clear Care. The total enrollment number of 75 represents a combined enrollment of the three studies, with some subjects participating in more than one study.
- Conditions
- Contact Lenses
- Being tested
- Opti-Free RepleniSH multi-purpose disinfecting solution, ReNu MultiPlus multi-purpose solution, Clear Care cleaning and disinfecting system, Senofilcon A contact lens (ACUVUE OASYS), Lotrafilcon B contact lens (AIR OPTIX AQUA)
- Keywords
- contact lenses, disinfection solutions, contact lens care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opti-Free RepleniSH multi-purpose disinfecting solutionDevice
Also called Opti-Free® RepleniSH®
Contact lens solution CE-marked for intended use.
ReNu MultiPlus multi-purpose solutionDevice
Also called ReNu® MultiPlus®
Contact lens solution CE-marked for intended use.
Clear Care cleaning and disinfecting systemDevice
Also called Clear Care®
Contact lens care system CE-marked for intended use.
Senofilcon A contact lens (ACUVUE OASYS)Device
Also called ACUVUE® OASYS™
Silicone hydrogel contact lens worn for two weeks on a daily wear basis and cleaned nightly with one of three contact lens care solutions. The order of solutions was randomized, and a fresh pair of lenses was dispensed with each solution.
Lotrafilcon B contact lens (AIR OPTIX AQUA)Device
Also called AIR OPTIX® AQUA
Silicone hydrogel contact lens worn for two weeks on a daily wear basis and cleaned nightly with one of three contact lens care solutions. The order of solutions was randomized, and a fresh pair of lenses was dispensed with each solution.
Comfilcon A contact lens (Biofinity)Device
Also called Biofinity®
Silicone hydrogel contact lens worn for two weeks on a daily wear basis and cleaned nightly with one of three contact lens care solutions. The order of solutions was randomized, and a fresh pair of lenses was dispensed with each solution.
| Study group | Role | What they receive |
|---|---|---|
| ACUVUE OASYS | Active comparator | Acuvue Oasys contact lenses worn on a daily wear basis and cleaned nightly with one of three contact lens care solutions. Each solution was used for 2 weeks, and the order in which the solutions were used was randomized. A fresh pair of lenses was dispensed with each solution. Total duration of contact lens wear was six weeks. Receives: Device: Opti-Free RepleniSH multi-purpose disinfecting solution; Device: ReNu MultiPlus multi-purpose solution; Device: Clear Care cleaning and disinfecting system; Device: Senofilcon A contact lens (ACUVUE OASYS) |
| AIR OPTIX AQUA | Active comparator | Air Optix Aqua contact lenses worn on a daily wear basis and cleaned nightly with one of three contact lens care solutions. Each solution was used for 2 weeks, and the order in which the solutions were used was randomized. A fresh pair of lenses was dispensed with each solution. Total duration of contact lens wear was six weeks. Receives: Device: Opti-Free RepleniSH multi-purpose disinfecting solution; Device: ReNu MultiPlus multi-purpose solution; Device: Clear Care cleaning and disinfecting system; Device: Lotrafilcon B contact lens (AIR OPTIX AQUA) |
| Biofinity | Active comparator | Biofinity contact lenses worn on a daily wear basis and cleaned nightly with one of three contact lens care solutions. Each solution was used for 2 weeks, and the order in which the solutions were used was randomized. A fresh pair of lenses was dispensed with each solution. Total duration of contact lens wear was six weeks. Receives: Device: Opti-Free RepleniSH multi-purpose disinfecting solution; Device: ReNu MultiPlus multi-purpose solution; Device: Clear Care cleaning and disinfecting system; Device: Comfilcon A contact lens (Biofinity) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modulus
Modulus is a measure of the stiffness of a contact lens material. Modulus is determined from the slope of the stress-strain curve created during tensile tests conducted on a sample of the material. Modulus is measured in mega Pascals (MPa). A higher modulus indicates a stiffer contact lens.
Measured: 2 weeks
Bulbar hyperemia
Bulbar hyperemia is the injection (or redness) of the blood vessels in the tissues overlaying the white of the eye. Bulbar hyperemia is measured on a 0-4 scale, with 0=none, 1=trace, 2=mild, 3=moderate, and 4=severe. Half-grades are allowed.
Measured: 2 weeks
Corneal staining type
An ophthalmic dye is used to highlight dead or degenerated corneal epithelial cells. The type of staining is measured over the five sectors of the cornea on a 0-4 scale, where 0=none, 1=micropunctate, 2=macropunctate, 3=coalesced macropunctate, and 4=patch (1mm). The five sectors are averaged to give a single score.
Measured: 2 weeks
Upper palpebral roughness
The roughness of the inner lining of the upper eyelid is measured on a 0-4 scale, where 0=uniform appearance, 1=trace, 2=mild, 3=moderate, and 4=severe. Half grades are allowed.
Measured: 2 weeks
High contrast visual acuity
High contrast visual acuity is a measure of the clearness of vision with full room illumination. Visual acuity is measured with a computer-generated, high contrast logMAR (logarithm minimum angle of resolution) chart.
Measured: 2 weeks
End of day comfort
As assessed by the subject as a measure of the comfort of the contact lenses at the end of an average day. End of day comfort is recorded on an 11-point scale where 0=poor and 10=excellent.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contact LensesStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00982046
- Sponsor's protocol ID
- M-09-05
- Status last verified
- Jul 2012
- First submitted
- 18 Sep 2009
- Last updated
- 16 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Program No 105358. Hall LA, Garofalo R, Young G. Clinical comparison of three contact lens systems in conjunction with senofilcon A, lotrafilcon B and comfilcon A daily wear lenses. American Academy of Optometry 2010.
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Comparison of Three Contact Lens Care Systems and Their Effect on Contact Lenses
- ClinicalTrials.gov ID
- NCT00982046
- Acronym / sponsor ID
- M-09-05
- Conditions
- Contact Lenses
- Keywords
- contact lenses, disinfection solutions, contact lens care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 22 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the clinical performance of three differing contact lens care solutions when used in conjunction with three contact lenses.
Detailed description
This study was conducted as three separate studies based on the contact lens brand dispensed. In each study, the contact lens was evaluated in conjunction with three solutions: Opti-Free Replenish, ReNu MultiPlus, and Clear Care. The total enrollment number of 75 represents a combined enrollment of the three studies, with some subjects participating in more than one study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ACUVUE OASYS | Active comparator | Device: Opti-Free RepleniSH multi-purpose disinfecting solution, Device: ReNu MultiPlus multi-purpose solution, Device: Clear Care cleaning and disinfecting system, Device: Senofilcon A contact lens (ACUVUE OASYS)Acuvue Oasys contact lenses worn on a daily wear basis and cleaned nightly with one of three contact lens care solutions. Each solution was used for 2 weeks, and the order in which the solutions were used was randomized. A fresh pair of lenses was dispensed with each solution. Total duration of contact lens wear was six weeks. |
| AIR OPTIX AQUA | Active comparator | Device: Opti-Free RepleniSH multi-purpose disinfecting solution, Device: ReNu MultiPlus multi-purpose solution, Device: Clear Care cleaning and disinfecting system, Device: Lotrafilcon B contact lens (AIR OPTIX AQUA)Air Optix Aqua contact lenses worn on a daily wear basis and cleaned nightly with one of three contact lens care solutions. Each solution was used for 2 weeks, and the order in which the solutions were used was randomized. A fresh pair of lenses was dispensed with each solution. Total duration of contact lens wear was six weeks. |
| Biofinity | Active comparator | Device: Opti-Free RepleniSH multi-purpose disinfecting solution, Device: ReNu MultiPlus multi-purpose solution, Device: Clear Care cleaning and disinfecting system, Device: Comfilcon A contact lens (Biofinity)Biofinity contact lenses worn on a daily wear basis and cleaned nightly with one of three contact lens care solutions. Each solution was used for 2 weeks, and the order in which the solutions were used was randomized. A fresh pair of lenses was dispensed with each solution. Total duration of contact lens wear was six weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent.
- Adapted contact lens wearer for at least one month.
- Spherical prescription range between +6.00 to -8.00 diopters.
- Astigmatism of less than or equal to 1.00 diopter in at least one eye.
- Normal eyes with no evidence of abnormality or disease.
Key exclusion criteria (6 listed)
- Rigid Gas Permeable (RGP) contact lens wear in last 30 days.
- Concurrent ocular medication, systemic illness, or medical treatment that will affect ocular physiology, lens performance, or vision.
- Corneal infiltrates, scarring, or neovascularization within central 4 millimeters of cornea.
- Eye injury or surgery within 8 weeks prior to study.
- Aphakia, amblyopia, abnormal lacrimal secretions, ocular irritation, keratoconus, corneal irregularity, pregnancy, lactating, planning to become pregnant during the study, and participation in a concurrent clinical trial.
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 |
|---|---|---|
| Opti-Free RepleniSH multi-purpose disinfecting solutionAlso: Opti-Free® RepleniSH®Contact lens solution CE-marked for intended use. | Device | ACUVUE OASYS, AIR OPTIX AQUA, Biofinity |
| ReNu MultiPlus multi-purpose solutionAlso: ReNu® MultiPlus®Contact lens solution CE-marked for intended use. | Device | ACUVUE OASYS, AIR OPTIX AQUA, Biofinity |
| Clear Care cleaning and disinfecting systemAlso: Clear Care®Contact lens care system CE-marked for intended use. | Device | ACUVUE OASYS, AIR OPTIX AQUA, Biofinity |
| Senofilcon A contact lens (ACUVUE OASYS)Also: ACUVUE® OASYS™Silicone hydrogel contact lens worn for two weeks on a daily wear basis and cleaned nightly with one of three contact lens care solutions. The order of solutions was randomized, and a fresh pair of lenses was dispensed with each solution. | Device | ACUVUE OASYS |
| Lotrafilcon B contact lens (AIR OPTIX AQUA)Also: AIR OPTIX® AQUASilicone hydrogel contact lens worn for two weeks on a daily wear basis and cleaned nightly with one of three contact lens care solutions. The order of solutions was randomized, and a fresh pair of lenses was dispensed with each solution. | Device | AIR OPTIX AQUA |
| Comfilcon A contact lens (Biofinity)Also: Biofinity®Silicone hydrogel contact lens worn for two weeks on a daily wear basis and cleaned nightly with one of three contact lens care solutions. The order of solutions was randomized, and a fresh pair of lenses was dispensed with each solution. | Device | Biofinity |
Primary outcome
Modulus
Time frame: 2 weeks
Modulus is a measure of the stiffness of a contact lens material. Modulus is determined from the slope of the stress-strain curve created during tensile tests conducted on a sample of the material. Modulus is measured in mega Pascals (MPa). A higher modulus indicates a stiffer contact lens.
Bulbar hyperemia
Time frame: 2 weeks
Bulbar hyperemia is the injection (or redness) of the blood vessels in the tissues overlaying the white of the eye. Bulbar hyperemia is measured on a 0-4 scale, with 0=none, 1=trace, 2=mild, 3=moderate, and 4=severe. Half-grades are allowed.
Corneal staining type
Time frame: 2 weeks
An ophthalmic dye is used to highlight dead or degenerated corneal epithelial cells. The type of staining is measured over the five sectors of the cornea on a 0-4 scale, where 0=none, 1=micropunctate, 2=macropunctate, 3=coalesced macropunctate, and 4=patch (1mm). The five sectors are averaged to give a single score.
Upper palpebral roughness
Time frame: 2 weeks
The roughness of the inner lining of the upper eyelid is measured on a 0-4 scale, where 0=uniform appearance, 1=trace, 2=mild, 3=moderate, and 4=severe. Half grades are allowed.
High contrast visual acuity
Time frame: 2 weeks
High contrast visual acuity is a measure of the clearness of vision with full room illumination. Visual acuity is measured with a computer-generated, high contrast logMAR (logarithm minimum angle of resolution) chart.
End of day comfort
Time frame: 2 weeks
As assessed by the subject as a measure of the comfort of the contact lenses at the end of an average day. End of day comfort is recorded on an 11-point scale where 0=poor and 10=excellent.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2016.
- Results publicationProgram No 105358. Hall LA, Garofalo R, Young G. Clinical comparison of three contact lens systems in conjunction with senofilcon A, lotrafilcon B and comfilcon A daily wear lenses. American Academy of Optometry 2010.
Related trials for Contact Lenses
Active, not recruiting
P1 Toric Vs. Max 1day
Eye, Astigmatism
Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
Astigmatism, Myopia
Active, not recruiting
Evaluation of Approved Contact Lenses (CR-6657)
Visual Acuity
Not yet recruiting
Using Contact Lenses and Spectacle Lenses as Myopia Interventions.
Myopia
Recruiting
Treating Contact Lens Discomfort With Cyclosporine 0.1% Ophthalmic Solution
Dry Eye Disease (DED), Contact Lens Discomfort (CLD)
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 Opti-Free RepleniSH multi-purpose disinfecting solution, ReNu MultiPlus multi-purpose solution and Clear Care cleaning and disinfecting system in people with Contact Lenses, run by Alcon Research at 1 site in United Kingdom.
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 6 inclusion and 6 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 16 Nov 2016. 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 Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Modulus (time frame: 2 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00982046, which also lists 1 linked publication.
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 16 Nov 2016.