Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Eye 0 0 0 0
Diseases / disorders of the eye

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
Sex
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
1/09/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2008
Sample size
Target
Accrual to date
Final
60
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/ct2/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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/ct2/show/NCT00531375