MyopiaNCT00732004
Time Course Comparison of Contact Lens Maintenance Systems for Hydrogel Lenses
A study testing Silicone Hydrogel Contact Lenses, 1x PMBH preserved MPS and 1x Polyquad/Aldox MPS in people with Myopia and Hyperopia, run by University of Melbourne at 1 site in Australia.
Trial summary
The principal aim of this project is to determine the time course of development of contact lens and contact lens case contamination during daily wear of silicone hydrogel lenses. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Silicone Hydrogel Contact Lenses, 1x PMBH preserved MPS and 1x Polyquad/Aldox MPS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2008to Apr 2009
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Distance contact lens prescription between +8.00 and -10.00D.
- Cylindrical component of refractive error no greater than 1.25D in either eye.
- Vision correctable to 6/12 (0.30 logMAR) or better in each eye.
- Healthy normal eyes without anterior segment infection, inflammation or abnormality, or significant slitlamp findings.
Who cannot join
- Concurrent ocular medication
- Eye injury or surgery within twelve weeks immediately prior to enrolment.
- Current ocular irritation that would preclude contact lens fitting.
- Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
- Pregnant, lactating or planning a pregnancy.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Clinical Vision Research Australia
Melbourne, Victoria, 3053
About this study
The principal aim of this project is to determine the time course of development of contact lens and contact lens case contamination during daily wear of silicone hydrogel lenses. The secondary aim of the study is to determine whether the time course of development of contact lens and contact lens case contamination varies between two different contact lens care systems.
- Being tested
- Silicone Hydrogel Contact Lenses, 1x PMBH preserved MPS, 1x Polyquad/Aldox MPS
- Medical subject headings
- Myopia, Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silicone Hydrogel Contact LensesDevice
1x PMBH preserved MPSDevice
1x Polyquad/Aldox MPSDevice
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Group 1 Receives: Device: Silicone Hydrogel Contact Lenses |
| 2 | Experimental | Group 2 Receives: Device: 1x PMBH preserved MPS |
| 3 | Experimental | Group 3 Receives: Device: 1x Polyquad/Aldox MPS |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionFeb 2009
- Study completionApr 2009
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Vision Research Australia, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732004
- Sponsor's protocol ID
- H08 002
- Status last verified
- Jun 2009
- First submitted
- 8 Aug 2008
- Last updated
- 2 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Course Comparison of Contact Lens Maintenance Systems for Hydrogel Lenses
- ClinicalTrials.gov ID
- NCT00732004
- Acronym / sponsor ID
- H08 002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Collaborators
- Clinical Vision Research Australia, Alcon Research
- Study start
- Aug 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 11 Aug 2008 (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 principal aim of this project is to determine the time course of development of contact lens and contact lens case contamination during daily wear of silicone hydrogel lenses. The secondary aim of the study is to determine whether the time course of development of contact lens and contact lens case contamination varies between two different contact lens care systems.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Silicone Hydrogel Contact LensesGroup 1 |
| 2 | Experimental | Device: 1x PMBH preserved MPSGroup 2 |
| 3 | Experimental | Device: 1x Polyquad/Aldox MPSGroup 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Distance contact lens prescription between +8.00 and -10.00D.
- Cylindrical component of refractive error no greater than 1.25D in either eye.
- Vision correctable to 6/12 (0.30 logMAR) or better in each eye.
- Healthy normal eyes without anterior segment infection, inflammation or abnormality, or significant slitlamp findings.
Key exclusion criteria (5 listed)
- Concurrent ocular medication
- Eye injury or surgery within twelve weeks immediately prior to enrolment.
- Current ocular irritation that would preclude contact lens fitting.
- Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
- Pregnant, lactating or planning a pregnancy.
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 |
|---|---|---|
| Silicone Hydrogel Contact Lenses | Device | 1 |
| 1x PMBH preserved MPS | Device | 2 |
| 1x Polyquad/Aldox MPS | Device | 3 |
Primary outcome
Not reported in the source record.
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 2 Jul 2009.
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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 Silicone Hydrogel Contact Lenses, 1x PMBH preserved MPS and 1x Polyquad/Aldox MPS in people with Myopia and Hyperopia, run by University of Melbourne at 1 site in Australia.
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 2 Jul 2009. 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 Australia. 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.
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 2 Jul 2009.