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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00441233




Registration number
NCT00441233
Ethics application status
Date submitted
27/02/2007
Date registered
28/02/2007
Date last updated
9/01/2008

Titles & IDs
Public title
Clinical Performance of Extended Wear Silicone Hydrogel Lenses
Scientific title
Secondary ID [1] 0 0
H07 001
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 daily wear 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?
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.

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?



Intervention assignment
Parallel
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
Commercial sector/Industry
Name [1] 0 0
Menicon Co., Ltd.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Clinical Vision Research Australia
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 clinical performance of a new
silicone hydrogel contact lens over a period of 6 months of extended wear.
Trial website
https://clinicaltrials.gov/show/NCT00441233
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Carol Lakkis, BScOptom, PhD, PGCertOcTher
Address 0 0
Clinical Vision Research Australia, University of Melbourne
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