MyopiaNCT00929487
Acute Clinical Evaluation of Multi-purpose Solutions (MPS) in Soft Contact Lens Wearers
A study testing Contact lens multi-purpose solution, Saline/blister pack solution and Contact lenses in people with Myopia, run by Alcon Research at 1 site in United Kingdom.
Trial summary
The purpose of this study was to clinically evaluate lens care solutions used with soft contact lenses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- Contact lens multi-purpose solution, Saline/blister pack solution and Contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2009to May 2012
- 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
- Have read, understood, signed, and dated the written Informed Consent.
- Be an adapted and successful soft contact lens wearer on a daily wear basis for at least two weeks.
- Vision correctable to at least 20/30 Snellen.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Topical ocular medication use.
- History of hypersensitivity to any component of the study contact lens care systems.
- Any slit-lamp finding of abnormal nature at the baseline visit assessment of each study period.
- Pregnant, lactating, or planning a pregnancy.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Visioncare Research, Ltd.
Farnham, Surrey, GU9 7EN
About this study
Official title: Acute Clinical Evaluation of MPS in Soft Contact Lens Wearers
The purpose of this study was to clinically evaluate lens care solutions used with soft contact lenses.
Read the detailed description
This study was conducted as a series of ten smaller studies in three countries using commercially available contact lens solutions per each country, ie, United Kingdom, France, and the Philippines. In each study, participants were assessed after use of up to 5 products (with one always being a control saline/blister pack solution) in randomized order in conjunction with one of the silicone hydrogel contact lenses. A total of 278 participants were enrolled in the 10 studies.
- Conditions
- Myopia
- Being tested
- Contact lens multi-purpose solution, Saline/blister pack solution, Contact lenses
- Keywords
- contact lens wear, contact lens solution, corneal staining
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contact lens multi-purpose solutionDevice
Also called ReNu Multiplus, Ote Hydroshield, Sauflon Synergi, Lapis Lazuli Eye See Aqua Balance
Lens care solutions CE-marked for intended use. A fresh pair of contact lenses was soaked overnight in the test contact lens solution and a pre-cycled lens case prior to study visit, then worn for two hours on the day of the study visit. Up to four solutions were evaluated in randomized order with the same brand of contact lenses, and a minimum of 12 hours of no lens wear separated each wear period.
Saline/blister pack solutionOther
Also called AMO OcuPure Saline, Saline
A fresh pair of contact lenses was soaked overnight in saline prior to study visit or was inserted directly from the blister pack, then worn for two hours on the day of the study visit.
Contact lensesDevice
Also called PureVision, Air Optix Aqua, Acuvue Advance, Biofinity
CE-marked silicone hydrogel contact lenses soaked overnight for at least 10 hours prior to the study visit, then worn for two hours on the day of the study visit. A fresh pair of the same brand of contact lenses was used for each overnight soak (ie, 4 solutions plus saline/blister pack solution), and a minimum of 12 hours separated each wear period.
| Study group | Role | What they receive |
|---|---|---|
| Contact lens solution #1 | Experimental | Not described Receives: Device: Contact lens multi-purpose solution; Device: Contact lenses |
| Contact lens solution #2 | Experimental | Not described Receives: Device: Contact lens multi-purpose solution; Device: Contact lenses |
| Contact lens solution #3 | Experimental | Not described Receives: Device: Contact lens multi-purpose solution; Device: Contact lenses |
| Contact lens solution #4 | Experimental | Not described Receives: Device: Contact lens multi-purpose solution; Device: Contact lenses |
| Saline/blister pack solution | Active comparator | Not described Receives: Other: Saline/blister pack solution; Device: Contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Staining
Measured: 2 hours
Secondary outcomes (1)
Subjective Comfort
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2012
- Study completionMay 2012
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 MyopiaStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 278 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
- NCT00929487
- Sponsor's protocol ID
- SMA-09-14/RDG-11-152
- Status last verified
- Sep 2012
- First submitted
- 25 Jun 2009
- Last updated
- 10 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Malet F. An acute clinical comparison of corneal staining and comfort associated with contact lens care solutions. Cont Lens Anterior Eye. 2014 Oct;37(5):351-7. doi: 10.1016/j.clae.2014.05.007. Epub 2014 Jul 26.
PubMed 25070393
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Clinical Evaluation of MPS in Soft Contact Lens Wearers
- ClinicalTrials.gov ID
- NCT00929487
- Acronym / sponsor ID
- SMA-09-14/RDG-11-152
- Conditions
- Myopia
- Keywords
- contact lens wear, contact lens solution, corneal staining
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 29 Jun 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 clinically evaluate lens care solutions used with soft contact lenses.
Detailed description
This study was conducted as a series of ten smaller studies in three countries using commercially available contact lens solutions per each country, ie, United Kingdom, France, and the Philippines. In each study, participants were assessed after use of up to 5 products (with one always being a control saline/blister pack solution) in randomized order in conjunction with one of the silicone hydrogel contact lenses. A total of 278 participants were enrolled in the 10 studies.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Contact lens solution #1 | Experimental | Device: Contact lens multi-purpose solution, Device: Contact lenses |
| Contact lens solution #2 | Experimental | Device: Contact lens multi-purpose solution, Device: Contact lenses |
| Contact lens solution #3 | Experimental | Device: Contact lens multi-purpose solution, Device: Contact lenses |
| Contact lens solution #4 | Experimental | Device: Contact lens multi-purpose solution, Device: Contact lenses |
| Saline/blister pack solution | Active comparator | Other: Saline/blister pack solution, Device: Contact lenses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have read, understood, signed, and dated the written Informed Consent.
- Be an adapted and successful soft contact lens wearer on a daily wear basis for at least two weeks.
- Vision correctable to at least 20/30 Snellen.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (5 listed)
- Topical ocular medication use.
- History of hypersensitivity to any component of the study contact lens care systems.
- Any slit-lamp finding of abnormal nature at the baseline visit assessment of each study period.
- Pregnant, lactating, or planning a pregnancy.
- Other protocol-defined exclusion criteria may apply.
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 |
|---|---|---|
| Contact lens multi-purpose solutionAlso: ReNu Multiplus, Ote Hydroshield, Sauflon Synergi, Lapis Lazuli Eye See Aqua BalanceLens care solutions CE-marked for intended use. A fresh pair of contact lenses was soaked overnight in the test contact lens solution and a pre-cycled lens case prior to study visit, then worn for two hours on the day of the study visit. Up to four solutions were evaluated in randomized order with the same brand of contact lenses, and a minimum of 12 hours of no lens wear separated each wear period. | Device | Contact lens solution #1, Contact lens solution #2, Contact lens solution #3, Contact lens solution #4 |
| Saline/blister pack solutionAlso: AMO OcuPure Saline, SalineA fresh pair of contact lenses was soaked overnight in saline prior to study visit or was inserted directly from the blister pack, then worn for two hours on the day of the study visit. | Other | Saline/blister pack solution |
| Contact lensesAlso: PureVision, Air Optix Aqua, Acuvue Advance, BiofinityCE-marked silicone hydrogel contact lenses soaked overnight for at least 10 hours prior to the study visit, then worn for two hours on the day of the study visit. A fresh pair of the same brand of contact lenses was used for each overnight soak (ie, 4 solutions plus saline/blister pack solution), and a minimum of 12 hours separated each wear period. | Device | Contact lens solution #1, Contact lens solution #2, Contact lens solution #3, Contact lens solution #4, Saline/blister pack solution |
Primary outcome
Corneal Staining
Time frame: 2 hours
1 secondary outcome
Subjective Comfort
Time frame: 2 hours
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 10 Sep 2012.
- Derived from this study: PubMed 25070393Malet F. An acute clinical comparison of corneal staining and comfort associated with contact lens care solutions. Cont Lens Anterior Eye. 2014 Oct;37(5):351-7. doi: 10.1016/j.clae.2014.05.007. Epub 2014 Jul 26.
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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 Contact lens multi-purpose solution, Saline/blister pack solution and Contact lenses in people with Myopia, 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 4 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 10 Sep 2012. 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?
Corneal Staining (time frame: 2 hours). 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 NCT00929487, 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 10 Sep 2012.