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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00363623




Registration number
NCT00363623
Ethics application status
Date submitted
10/08/2006
Date registered
15/08/2006
Date last updated
21/03/2008

Titles & IDs
Public title
Comparison of Contact Lens Maintenance Systems for Silicone Hydrogel Lenses
Scientific title
Secondary ID [1] 0 0
H06 009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 0 0
Hyperopia 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
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
* Is correctable to at least 20/40 distance visual acuity in each eye with spherical contact lenses.
* Is an experienced soft contact lens wearer for at least 1 month.
* Has no clinically significant anterior eye findings.
* Has no other active ocular disease.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Requires concurrent ocular medication.
* Eye surgery or injury within 12 weeks prior to enrolment.
* Has any systemic disease or ocular abnormality that might interfere with contact lens wear
* Has any pre-existing ocular irritation that would preclude contact lens fitting.
* PMMA lens wear previous 6 months.
* EW or CW in previous 1 month.
* Hydrogen peroxide users
* 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?



Intervention assignment
Single group
Other design features
Phase
NA
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
1/08/2006
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
Commercial sector/industry
Name [1] 0 0
CIBA VISION
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Carol Lakkis, BScOptom, PhD
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

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 not provided in https://clinicaltrials.gov/study/NCT00363623