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Trial registered on ANZCTR


Registration number
ACTRN12610000662066
Ethics application status
Approved
Date submitted
13/08/2010
Date registered
13/08/2010
Date last updated
13/08/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Testing the efficacy of the Developed Lens Case Hygiene Guidelines in lens wearers
Scientific title
Testing of the developed lens case hygiene guidelines in lens wearers to assess the effect of biofilm reduction in lens cases
Secondary ID [1] 252441 0
Nil
Universal Trial Number (UTN)
Trial acronym
contact lens case
Linked study record

Health condition
Health condition(s) or problem(s) studied:
contamination in contact lens storage cases 257944 0
Condition category
Condition code
Eye 258111 258111 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lens wearers are asked to follow a lens case cleaning guideline for one month:
1. Rinse contact lens case once with disinfecting solution after use (minimum 5 times per week)
2. Rub lens cases with fingers for 5 seconds
3. Wipe lens cases with tissue for 5 seconds
4. Air-dry the lens case face down

The disinfecting solution given to participants is called AMO Complete, a commercially available lens care product

After one month, participants are switched to the control treament (no washout period)
Intervention code [1] 256999 0
Behaviour
Intervention code [2] 257009 0
Prevention
Comparator / control treatment
Lens wearers are asked to follow current manufacturers' lens case cleaning guideline for one month: 1. Rinse contact lens case with disinfecting solution after use 2.Air-dry the case
(This is printed on the manufaturers guidelines, no more specific infomation are available)

The disinfecting solution given to participants is called AMO Complete, a commercially available lens care product

After one month, participants are switched to the intervention treament (no washout period)
Control group
Active

Outcomes
Primary outcome [1] 258975 0
Two log unit of colony forming unit (CFU) reduction in the level of bacteria in the treatment cases when compared to that of the controls.
The total viable bacterial count is measured by swabbing the lens cases and plating onto agar plates.
Timepoint [1] 258975 0
The outcome is assessed at the one month (first arm of the trial) and the two month timepoint (when the study is completed).
Secondary outcome [1] 265164 0
nil
Timepoint [1] 265164 0
nil

Eligibility
Key inclusion criteria
contact lens wearers who use lens cases at least five times a week to store their contact lenses.
Age: 16-70
Minimum age
16 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
active eye diseases

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Contact lens wearers who attend the Optometry clinic of the University of New South Wales will be invited to participate in this study. A recruiting poster will be displayed in a notice board of the School clinic.Contact lens wearers who are interested can contact the investigator by e-mail or phone. Participants are assigned to either control or case group according to a randomised table
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
a randomised table that was from a statistic book.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257449 0
Other Collaborative groups
Name [1] 257449 0
Brien Holden Vision Institute
Country [1] 257449 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Level 3 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 256679 0
None
Name [1] 256679 0
Address [1] 256679 0
Country [1] 256679 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259477 0
The University of New South Wales-Human Research Ethics Advisory Panels
Ethics committee address [1] 259477 0
Ethics committee country [1] 259477 0
Australia
Date submitted for ethics approval [1] 259477 0
Approval date [1] 259477 0
20/05/2010
Ethics approval number [1] 259477 0
HREA 10026

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

Contacts
Principal investigator
Name 31515 0
Address 31515 0
Country 31515 0
Phone 31515 0
Fax 31515 0
Email 31515 0
Contact person for public queries
Name 14762 0
Yvonne Wu
Address 14762 0
Level 3 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Country 14762 0
Australia
Phone 14762 0
+61 2 9385 7603
Fax 14762 0
Email 14762 0
y.wu@brienholdenvision.org
Contact person for scientific queries
Name 5690 0
Yvonne Wu
Address 5690 0
Level 3 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Country 5690 0
Australia
Phone 5690 0
+61 2 9385 7603
Fax 5690 0
Email 5690 0
y.wu@brienholdenvision.org

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.