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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00531375




Registration number
NCT00531375
Ethics application status
Date submitted
17/09/2007
Date registered
18/09/2007
Date last updated
19/11/2008

Titles & IDs
Public title
The Effect of Silicone Hydrogel Contact Lenses on Conjunctival Flora
Scientific title
Secondary ID [1] 0 0
H07 003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Silicone hydrogel contact lens

Treatment: Devices: Silicone hydrogel contact lens


Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Clinical Vision Research Australia - Melbourne
Recruitment postcode(s) [1] 0 0
3053 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Clinical Vision Research Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Johnson & Johnson Vision Care, Inc.
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT00531375
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Carol Lakkis, BScOptom, PhD, PGCertOcTher
Address 0 0
Clinical Vision Research Australia, Victorian College of Optometry
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications