MyopiaNCT00531375
The Effect of Silicone Hydrogel Contact Lenses on Conjunctival Flora
A study testing Silicone hydrogel contact lens in people with Myopia, run by University of Melbourne at 1 site in Australia.
Trial summary
The primary purpose of this study is to investigate the effect of silicone hydrogel contact lenses on conjunctival flora over a period of 6 months of daily wear. A secondary aim is to compare the levels of microbial contamination of silicone hydrogel lenses after daily wear. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Silicone hydrogel contact lens
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteAustralia
- Study dates
- Sep 2007to Sep 2008
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is correctable to at least 6/9 distance visual acuity in each eye with spherical contact lenses.
- Is a current full time soft contact lens wearer.
- Has no clinically significant anterior eye findings.
- Has no other active ocular disease
Who cannot join
- Has any systemic disease that might interfere with contact lens wear
- Is using any systemic or topical medications that will affect ocular health.
- Has any pre-existing ocular irritation that would preclude contact lens fitting.
- Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
- Has undergone corneal refractive surgery.
- Is pregnant, lactating or planning a pregnancy.
- Is participating in a concurrent clinical trial.
- Has a latex sensitivity.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Clinical Vision Research Australia
Melbourne, Victoria, 3053
About this study
The primary purpose of this study is to investigate the effect of silicone hydrogel contact lenses on conjunctival flora over a period of 6 months of daily wear. A secondary aim is to compare the levels of microbial contamination of silicone hydrogel lenses after daily wear.
- Conditions
- Myopia
- Being tested
- Silicone hydrogel contact lens
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silicone hydrogel contact lensDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionJun 2008
- Study completionSep 2008
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Vision Research Australia, Johnson & Johnson Vision Care, Inc.
- Investigators
- Carol Lakkis, BScOptom, PhD, PGCertOcTher, Principal investigator, Clinical Vision Research Australia, Victorian College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00531375
- Sponsor's protocol ID
- H07 003
- Status last verified
- Nov 2008
- First submitted
- 17 Sep 2007
- Last updated
- 19 Nov 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Silicone Hydrogel Contact Lenses on Conjunctival Flora
- ClinicalTrials.gov ID
- NCT00531375
- Acronym / sponsor ID
- H07 003
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Collaborators
- Clinical Vision Research Australia, Johnson & Johnson Vision Care, Inc.
- Study start
- Sep 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 18 Sep 2007 (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 primary purpose of this study is to investigate the effect of silicone hydrogel contact lenses on conjunctival flora over a period of 6 months of daily wear. A secondary aim is to compare the levels of microbial contamination of silicone hydrogel lenses after daily wear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Is correctable to at least 6/9 distance visual acuity in each eye with spherical contact lenses.
- Is a current full time soft contact lens wearer.
- Has no clinically significant anterior eye findings.
- Has no other active ocular disease
Key exclusion criteria (8 listed)
- Has any systemic disease that might interfere with contact lens wear
- Is using any systemic or topical medications that will affect ocular health.
- Has any pre-existing ocular irritation that would preclude contact lens fitting.
- Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
- Has undergone corneal refractive surgery.
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 lens | Device | – |
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 19 Nov 2008.
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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.
Carol Lakkis, BScOptom, PhD, PGCertOcTher principal investigator
Clinical Vision Research Australia, Victorian College of Optometry
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 lens in people with Myopia, 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 8 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 19 Nov 2008. 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 19 Nov 2008.