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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/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
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 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
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
1/08/2006
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
The primary purpose of this study is to investigate the performance of contact lens
maintenance systems when used with silicone hydrogel contact lenses during daily wear over a
period of 1 month.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00363623
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00363623