Normal Contact Lens WearersNCT01294917
Comparison of a New Abbott Medical Optics (AMO) Multi-Purpose Solution (MPS) to Existing Contact Lens Regimens
A study testing Multi-purpose disinfecting solution, Clear Care and Opti-Free RepleniSH in people with Normal Contact Lens Wearers, run by Abbott Medical Optics at 1 site in Canada.
Trial summary
Crossover clinical evaluation three contact lens care regimens used for one month with Acuvue Oasys lenses. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Normal Contact Lens Wearers
- What is being tested?
- Multi-purpose disinfecting solution, Clear Care and Opti-Free RepleniSH
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2011to Aug 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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Is at least 17 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Has had an ocular examination in the last two years;
- Is a current soft lens wearer using either two-week or monthly replacement lenses;
- Is correctable to a visual acuity of 6/7.5 (20/25) or better (both eyes) with their habitual vision correction (either spectacles or contact lenses);
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- Has normal binocular vision (no strabismus, no amblyopia);
- Has clear corneas and no active ocular disease;
- Has a distance contact lens prescription between +8.00 diopters (D) to -12.00 D and a successful fit with the study lenses;
- Has astigmatism less than or equal to -1.00 D;
- Agrees to wear the study lenses on a daily wear basis.
Who cannot join
- Has any active ocular disease;
- Has any clinically significant lid, conjunctival, or corneal abnormalities that may affect a study outcome variable;
- Has undergone corneal refractive surgery;
- Has a systemic condition that may affect a study outcome variable;
- Is using any systemic or topical medications that may affect ocular health;
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
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- Is pregnant or lactating;
- Is participating in any other clinical or research study that may affect a study outcome variable;
- Currently wears daily disposable lenses or extended wear lenses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of a New AMO MPS to Existing Contact Lens Regimens
Crossover clinical evaluation three contact lens care regimens used for one month with Acuvue Oasys lenses.
Read the detailed description
This is a three-arm crossover clinical evaluation of 40 subjects who will use each of three contact lens care regimens for one month with Acuvue Oasys lenses. The subjects will be randomized on the order of solutions used: Investigational MPS, ClearCare, and Opti-Free RepleniSH MPS.
- Conditions
- Normal Contact Lens Wearers
- Being tested
- Multi-purpose disinfecting solution, Clear Care, Opti-Free RepleniSH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-purpose disinfecting solutionDevice
For the cleaning, rinsing, and storage of soft contact lenses.
Clear CareDevice
Peroxide-based regimen for cleaning and disinfecting soft contact lenses.
Opti-Free RepleniSHDevice
Multi-purpose disinfecting solution for the cleaning, rinsing and storing of soft contact lenses.
| Study group | Role | What they receive |
|---|---|---|
| Investigational MPS | Experimental | AMO Investigational MPS. Receives: Device: Multi-purpose disinfecting solution |
| Clear Care | Active comparator | Peroxide-based lens care regimen. Receives: Device: Clear Care |
| Opti-Free RepleniSH | Active comparator | Multi-purpose disinfecting solution (Alcon). Receives: Device: Opti-Free RepleniSH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Staining
Corneal staining will be assessed with sodium fluorescein dye on the ocular surface. The cornea is split into 5 sections, each section is evaluated by staining type, depth, and extent is graded on a 0 to 100 scale with higher scores indicating more staining. The possible total range for the total score per eye is 0 to 50,000 (100x100x100=10,000 per section) with values higher than 1200 being clinically relevant.
Measured: 4 weeks
Secondary outcomes (2)
Subjective Lens Wearing Comfort
This will be assessed by a questionnaire on patient-perceived lens comfort and any symptoms of discomfort on a 0 to 100 scale.
Measured: 4 weeks
Dryness
This will be assessed by the tear break-up time on the lens surface, measured in seconds.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionAug 2011
- Study completionAug 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 Normal Contact Lens WearersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Optics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Craig Woods, MOptom, Principal investigator, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01294917
- Sponsor's protocol ID
- COBR-305-9608
- Status last verified
- Jan 2017
- First submitted
- 10 Feb 2011
- Last updated
- 6 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a New AMO MPS to Existing Contact Lens Regimens
- ClinicalTrials.gov ID
- NCT01294917
- Acronym / sponsor ID
- COBR-305-9608
- Conditions
- Normal Contact Lens Wearers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Abbott Medical OpticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 14 Feb 2011 (estimated)
- Results
- Posted 14 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Crossover clinical evaluation three contact lens care regimens used for one month with Acuvue Oasys lenses.
Detailed description
This is a three-arm crossover clinical evaluation of 40 subjects who will use each of three contact lens care regimens for one month with Acuvue Oasys lenses. The subjects will be randomized on the order of solutions used: Investigational MPS, ClearCare, and Opti-Free RepleniSH MPS.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Investigational MPS | Experimental | Device: Multi-purpose disinfecting solutionAMO Investigational MPS. |
| Clear Care | Active comparator | Device: Clear CarePeroxide-based lens care regimen. |
| Opti-Free RepleniSH | Active comparator | Device: Opti-Free RepleniSHMulti-purpose disinfecting solution (Alcon). |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Is at least 17 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Has had an ocular examination in the last two years;
- Is a current soft lens wearer using either two-week or monthly replacement lenses;
Key exclusion criteria (9 listed)
- Has any active ocular disease;
- Has any clinically significant lid, conjunctival, or corneal abnormalities that may affect a study outcome variable;
- Has undergone corneal refractive surgery;
- Has a systemic condition that may affect a study outcome variable;
- Is using any systemic or topical medications that may affect ocular health;
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 |
|---|---|---|
| Multi-purpose disinfecting solutionFor the cleaning, rinsing, and storage of soft contact lenses. | Device | Investigational MPS |
| Clear CarePeroxide-based regimen for cleaning and disinfecting soft contact lenses. | Device | Clear Care |
| Opti-Free RepleniSHMulti-purpose disinfecting solution for the cleaning, rinsing and storing of soft contact lenses. | Device | Opti-Free RepleniSH |
Primary outcome
Corneal Staining
Time frame: 4 weeks
Corneal staining will be assessed with sodium fluorescein dye on the ocular surface. The cornea is split into 5 sections, each section is evaluated by staining type, depth, and extent is graded on a 0 to 100 scale with higher scores indicating more staining. The possible total range for the total score per eye is 0 to 50,000 (100x100x100=10,000 per section) with values higher than 1200 being clinically relevant.
2 secondary outcomes
Subjective Lens Wearing Comfort
Time frame: 4 weeks
Dryness
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
- 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.
Craig Woods, MOptom principal investigator
University of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-purpose disinfecting solution, Clear Care and Opti-Free RepleniSH in people with Normal Contact Lens Wearers, run by Abbott Medical Optics at 1 site in Canada.
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 11 inclusion and 9 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 6 Mar 2017. 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 Canada. 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 14 May 2012). 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?
Corneal Staining (time frame: 4 weeks). 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 6 Mar 2017.