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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/NCT00732004




Registration number
NCT00732004
Ethics application status
Date submitted
8/08/2008
Date registered
11/08/2008
Date last updated
2/07/2009

Titles & IDs
Public title
Time Course Comparison of Contact Lens Maintenance Systems for Hydrogel Lenses
Scientific title
Secondary ID [1] 0 0
H08 002
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 Lenses
Treatment: Devices - 1x PMBH preserved MPS
Treatment: Devices - 1x Polyquad/Aldox MPS

Experimental: 1 - Group 1

Experimental: 2 - Group 2

Experimental: 3 - Group 3


Treatment: Devices: Silicone Hydrogel Contact Lenses


Treatment: Devices: 1x PMBH preserved MPS


Treatment: Devices: 1x Polyquad/Aldox MPS
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
- Distance contact lens prescription between +8.00 and -10.00D.

- Cylindrical component of refractive error no greater than 1.25D in either eye.

- Vision correctable to 6/12 (0.30 logMAR) or better in each eye.

- Healthy normal eyes without anterior segment infection, inflammation or abnormality,
or significant slitlamp findings.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Concurrent ocular medication

- Eye injury or surgery within twelve weeks immediately prior to enrolment.

- Current ocular irritation that would preclude contact lens fitting.

- Evidence of systemic or ocular abnormality, infection or disease likely to affect
successful wear of contact lenses or use of their accessory solutions.

- Pregnant, lactating or planning a pregnancy.

Study design
Purpose of the study
Basic Science
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 analysing the results/data
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
1/08/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2009
Sample size
Target
132
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
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
Alcon Research
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The principal aim of this project is to determine the time course of development of contact
lens and contact lens case contamination during daily wear of silicone hydrogel lenses. The
secondary aim of the study is to determine whether the time course of development of contact
lens and contact lens case contamination varies between two different contact lens care
systems.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00732004
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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