Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000557336
Ethics application status
Approved
Date submitted
17/09/2008
Date registered
7/11/2008
Date last updated
23/07/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of lens wear on bacterial adhesion to lens surfaces
Scientific title
A prospective, randomised, open label, parallel group, cross-over design clinical trial to investigate protein and lipid deposition that mediate bacterial adhesion on the surface of silicone hydrogel contact lenses with use of different lens care solutions during daily and extended wear.
Universal Trial Number (UTN)
Trial acronym
Effect of lens wear on bacterial adhesion to lens surfaces
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Protein and lipid deposition on the surface of silicone hydrogel lenses during daily wear and extended wear of contact lenses 3709 0
Condition category
Condition code
Eye 3876 3876 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lens care solution crossover during 2 months daily wear (i.e. wear lenses during the day and remove lenses prior to sleep) of silicone hydrogel lenses. 1 month extended wear (continuous wear during the day and night) of silicone hydrogel lenses. There is a 1 calender day washout between treatments. At start of daily wear, each group will be randomly assigned to use either Optifree-Replenish (Alcon, USA) or Menicare Soft (Menicon, Japan) lens care solution. After one month daily wear, subjects will be dispensed with the alternate lens care solution. Subjects will continue with this solution for the duration of the trial (i.e. one further month of daily lens wear and 1 month of extended lens wear).
Intervention code [1] 3421 0
Treatment: Devices
Comparator / control treatment
Active control - crossover study
Control group
Active

Outcomes
Primary outcome [1] 4779 0
To identify the proteins and lipids that deposit on a lens surface and to determine which proteins and lipids mediate bacterial adhesion to the lens surface. Extracted proteins to be separated by nano-Liquid Chromatography (LC) and Mass Spectrometry (MS). Concentration of each protein determined by Enzyme-Linked ImmunoSorbent Assay (ELISA). Extracted lipids to be separated by Thin Layer Chromatography (TLC) and amounts of lipids measured using standard curves on TLC plates.
Timepoint [1] 4779 0
At 1 month, 2 months and 3 months from the baseline visit
Secondary outcome [1] 8077 0
N/A
Timepoint [1] 8077 0
N/A

Eligibility
Key inclusion criteria
Be able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;
Be at least 18 years old;
Be willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator;
Have ocular health findings considered to be 'normal' and which would not prevent the participant from safely wearing contact lenses;
Have experienced an ocular adverse event that is not considered to be severe by the Investigator (Investigator discretion) or that is temporary in nature;
Is correctable to at least 6/12 (20/40) or better in each eye with contact lenses;
Be experienced or may be inexperienced at wearing contact lenses
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pre-existing ocular irritation, injury or condition that would preclude contact lens fitting and safe wearing of contact lenses;
any systemic disease that adversely affects ocular health; active corneal infection or any active ocular disease that would affect wearing of contact lenses;
previously experienced a severe contact lens related adverse event (Investigator discretion), that is likely to affect their contact lens wear experience or present a significant safety risk during the trial;
any prescribed systemic medication or topical medications which may alter normal ocular findings/are known to affect a participant’s ocular health/physiology or contact lens performance either in an adverse or beneficial manner;
previous corneal refractive surgery;
contraindications to contact lens wear;
currently enrolled in another clinical trial;
participation in a clinical trial within the previous 2 weeks;pregnant or lactating women who are not able to complete the study (Investigator discretion).

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)
Participants will be randomly assigned to one of two different lens types, followed by a within group design (solution allocation). Allocation will be concealed and done by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation plan will be generated by computer
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
Completed
Date of first participant enrolment
Anticipated
31/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3890 0
Charities/Societies/Foundations
Name [1] 3890 0
Institute for Eye Research
Country [1] 3890 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Institute for Eye Research
Address
Level 5, North Wing, Rupert Myers Building
Gate 14, Barker St
Kensington NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 3491 0
None
Name [1] 3491 0
Address [1] 3491 0
Country [1] 3491 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5938 0
Vision Cooperative Research Centre and Institute for Eye Research Human Ethics Committee (VIHEC)
Ethics committee address [1] 5938 0
Ethics committee country [1] 5938 0
Australia
Date submitted for ethics approval [1] 5938 0
18/06/2008
Approval date [1] 5938 0
23/07/2008
Ethics approval number [1] 5938 0
08/06

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

Contacts
Principal investigator
Name 28946 0
Address 28946 0
Country 28946 0
Phone 28946 0
Fax 28946 0
Email 28946 0
Contact person for public queries
Name 12103 0
Mr Jerome Ozkan
Address 12103 0
Institute for Eye Research
Level 5, Rupert Myers Building
Gate 14 Barker St
University of New South Wales (UNSW), Kensington NSW 2052
Country 12103 0
Australia
Phone 12103 0
+61 2 93857516
Fax 12103 0
+61 2 93857401
Email 12103 0
j.ozkan@ier.org.au
Contact person for scientific queries
Name 3031 0
Professor Mark Willcox
Address 3031 0
Institute for Eye Research
Level 4, Rupert Myers Building
Gate 14 Barker St
University of New South Wales (UNSW), Kensington NSW 2052
Country 3031 0
Australia
Phone 3031 0
+61 2 93857516
Fax 3031 0
+61 2 93857401
Email 3031 0
m.willcox@ier.org.au

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.