MyopiaNCT01019564
Complete Easy Rub Comparative Efficacy Study
A study testing Complete Easy Rub Formula MPS and Aquify MPS in people with Myopia and Hyperopia, run by Abbott Medical Optics.
Trial summary
The aim of this trial is to assess Complete Easy Rub compared to a competitor multi-purpose solution in terms of lens cleanliness, subjective response and ocular response, when lenses are worn bilaterally on a daily wear basis for two months. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Hyperopia, Astigmatism
- What is being tested?
- Complete Easy Rub Formula MPS and Aquify MPS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2009to Mar 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;
- Be at least 18 years old, male or female;
- Willing to comply with the wearing and clinical trial visit schedule as directed by the investigator;
- Have ocular health findings considered to be "normal" and which would not prevent the participant from safely wearing contact lenses;
- Is correctable to at least 6/12 (20/40) or better in each eye with contact lenses;
- Able to successfully wear one of the lens types to be used in this study on a daily wear (DW) basis in conjunction with any multi-purpose contact lens care solution (not including hydrogen peroxide-based systems) for at least one month prior to allocation of test or control solution;
Who cannot join
- Any pre-existing ocular irritation, injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses;
- Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants;
- Use of, or a need for, concurrent category S3 and above ocular medication at enrolment and/or during the study;
- Use of, or a need for, any systemic medication or topical medications which may alter normal ocular findings/are known to affect a participant's ocular health/physiology or contact lens performance either in an adverse manner or beneficial manner at enrolment and/or during the study
About this study
The aim of this trial is to assess Complete Easy Rub compared to a competitor multi-purpose solution in terms of lens cleanliness, subjective response and ocular response, when lenses are worn bilaterally on a daily wear basis for two months.
The hypotheses for this trial are:
- Lens cleanliness measures between solutions will be no different.
- Subjective ratings between solutions will be no different.
- Ocular response between solutions will be no different.
- Conditions
- Myopia, Hyperopia, Astigmatism
- Being tested
- Complete Easy Rub Formula MPS, Aquify MPS
- Medical subject headings
- Myopia, Hyperopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete Easy Rub Formula MPSDevice
Multi-purpose solution
Aquify MPSDevice
Multi-purpose solution
| Study group | Role | What they receive |
|---|---|---|
| Easy Rub MPS | Experimental | Complete Easy Rub Formula MPS Receives: Device: Complete Easy Rub Formula MPS |
| Aquify MPS | Active comparator | Not described Receives: Device: Aquify MPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of lens cleanliness of test and control solutions when used with soft lenses at the end of the manufacturer-recommended replacement interval.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionMar 2010 (estimated)
- Study completionMar 2010 (estimated)
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Optics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019564
- Sponsor's protocol ID
- COMP-319-9424
- Status last verified
- Jan 2025
- First submitted
- 20 Nov 2009
- Last updated
- 3 Feb 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complete Easy Rub Comparative Efficacy Study
- ClinicalTrials.gov ID
- NCT01019564
- Acronym / sponsor ID
- COMP-319-9424
- Conditions
- Myopia, Hyperopia, Astigmatism
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abbott Medical OpticsIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 25 Nov 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 aim of this trial is to assess Complete Easy Rub compared to a competitor multi-purpose solution in terms of lens cleanliness, subjective response and ocular response, when lenses are worn bilaterally on a daily wear basis for two months.
The hypotheses for this trial are:
- Lens cleanliness measures between solutions will be no different.
- Subjective ratings between solutions will be no different.
- Ocular response between solutions will be no different.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Easy Rub MPS | Experimental | Device: Complete Easy Rub Formula MPSComplete Easy Rub Formula MPS |
| Aquify MPS | Active comparator | Device: Aquify MPS |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;
- Be at least 18 years old, male or female;
- Willing to comply with the wearing and clinical trial visit schedule as directed by the investigator;
- Have ocular health findings considered to be "normal" and which would not prevent the participant from safely wearing contact lenses;
- Is correctable to at least 6/12 (20/40) or better in each eye with contact lenses;
Key exclusion criteria (4 listed)
- Any pre-existing ocular irritation, injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses;
- Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants;
- Use of, or a need for, concurrent category S3 and above ocular medication at enrolment and/or during the study;
- Use of, or a need for, any systemic medication or topical medications which may alter normal ocular findings/are known to affect a participant's ocular health/physiology or contact lens performance either in an adverse manner or beneficial manner at enrolment and/or during the study
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 |
|---|---|---|
| Complete Easy Rub Formula MPSMulti-purpose solution | Device | Easy Rub MPS |
| Aquify MPSMulti-purpose solution | Device | Aquify MPS |
Primary outcome
Evaluation of lens cleanliness of test and control solutions when used with soft lenses at the end of the manufacturer-recommended replacement interval.
Time frame: Day 30
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Complete Easy Rub Formula MPS and Aquify MPS in people with Myopia and Hyperopia, run by Abbott Medical Optics.
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 4 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: withdrawn, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Evaluation of lens cleanliness of test and control solutions when used with soft lenses at the end of the manufacturer-recommended replacement interval. (time frame: Day 30). 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 3 Feb 2025.