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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/NCT00346593




Registration number
NCT00346593
Ethics application status
Date submitted
29/06/2006
Date registered
30/06/2006
Date last updated
12/02/2007

Titles & IDs
Public title
Investigation of the Clinical Performance of Silicone Hydrogel Contact Lenses During Continuous Wear
Scientific title
Secondary ID [1] 0 0
H03 010
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
- Has had an oculo-visual examination in the last 2 years.

- Is correctable to at least 6/7.5 distance visual acuity in each eye with spherical
contact lenses.

- Is a current 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?
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
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
1/05/2004
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 - Carlton
Recruitment postcode(s) [1] 0 0
3053 - Carlton

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
Cooper Companies
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 during continuous wear (up to 30 nights) over a period of 24
months.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00346593
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Carol Lakkis, BScOptom PhD
Address 0 0
Clinical Vision Research Australia
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00346593