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Trial registered on ANZCTR


Registration number
ACTRN12610000348055
Ethics application status
Approved
Date submitted
19/04/2010
Date registered
30/04/2010
Date last updated
15/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective, single-group, open label, bilateral daily wear clinical trial to investigate microbial contamination of three contact lens cases (Sauflon i-clean [registered] antibacterial case, Sauflon silver barrel case and Sauflon regular flat case), and correlations between Demodex, ocular discomfort and ocular measures in contact lens wearers, when used in conjunction with marketed PureVision [trademark] contact lenses and Synergi multipurpose solution
Scientific title
A prospective, single-group, open label, bilateral daily wear clinical trial to investigate microbial contamination of three contact lens cases (Sauflon i-clean [registered] antibacterial case, Sauflon silver barrel case and Sauflon regular flat case), and correlations between Demodex, ocular discomfort and ocular measures in contact lens wearers, when used in conjunction with marketed PureVision [trademark] contact lenses and Synergi multipurpose solution
Secondary ID [1] 251652 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contact lens wear 257219 0
Condition category
Condition code
Eye 257357 257357 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective, bilateral, open-label, randomised clinical trial with participants wearing commercially available PureVision [Trade mark] contact lenses in conjunction with an Synergi contact lens care solution and i-clean [registered] contact lens case, over a 3 month period on a daily wear basis.
All participants will use the same product types. There are visits at 2 weeks, 1 month and 3 months from initial lens fitting. Contact lens cases will be collected at the 1 month and 3 months visits for analysis.
This study will have a of minimum of 40 participants.
Intervention code [1] 256339 0
Treatment: Devices
Comparator / control treatment
Historical control. The study to which we will be comparing this study (one study within 'Prospective, open label, multi-block study of currently marketed 'contact lenses' and 'lens care solutions' to evaluate eye and product performance in both experienced & new contact lens wearers'- investigator J. Diec) used the same lens type and similar visit schedule as the current study. The differences are the type of lens case and solution used. In the historical control a regular lens case was used. The method of analysis of cases will be as per historical control
Control group
Historical

Outcomes
Primary outcome [1] 258259 0
To assess microbial contamination of i-clean antibacterial contact lens storage cases when used in conjunction with PureVision lenses and Synergi multipurpose solution during daily wear.
Used contact lens storage cases will be collected during and at the end of the clinical trial and transferred to the Brien Holden Vision Institute microbiology laboratory. Swab samples will be taken from inner surfaces of lens cases for routine microbiology isolation and identification. Contamination rate of used cases will be then determined based on data from microbiological analysis
Timepoint [1] 258259 0
After 1 month and 3 months of contact lens wear
Secondary outcome [1] 263917 0
To determine if the presence of Demodex correlates with discomfort and ocular measurements in a normal contact lens wearing population.
Eye lashes removed from participants will be fixed on a slide, and the presence of Demodex will be determined following microscopic examination
Timepoint [1] 263917 0
baseline, 2 weeks, 1 month and 3 months of contact lens wear
Secondary outcome [2] 265626 0
To assess microbial contamination of Sauflon silver barrel cases and Sauflon regular barrel cases after one month of wear
Timepoint [2] 265626 0
1 month of wear each, after 4 months and 5 months of contact lens wear

Eligibility
Key inclusion criteria
-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;
-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;
-Has vision 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
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-Any pre-existing ocular irritation, injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses;
-Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosis. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants;
-An active corneal infection or any active ocular disease that would affect wearing of contact lenses;
-Use of or a need for concurrent category S3 and above ocular medication up to 12 weeks prior to and during the trial;
-Use of or a need for any 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 manner or risk providing a false positive.
N.B. Systemic antihistamines are allowed on an ‘as needed basis’, provided they are not used prophylactically during the trial;
-Eye surgery within 12 weeks immediately prior to enrolment for this trial;
-Previous corneal refractive surgery;
-Contraindications to contact lens wear;
-Currently enrolled in another clinical trial;
-Be pregnant*

The Investigator may, at his/her discretion, exclude anyone else who they believe may not be able to fulfil the study requirements, or if it is believed to be in the participant’s best interests.

* Formal testing of pregnancy is not required. A participant’s verbal report is sufficient.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
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)

Funding & Sponsors
Funding source category [1] 256841 0
Charities/Societies/Foundations
Name [1] 256841 0
Brien Holden Vision Institute
Address [1] 256841 0
Level 5, Rupert Myers Building Gate 14, Barker Street University of New South Wales, NSW 2052
Country [1] 256841 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Brien Holden Vision Institute
Address
Level 5, Rupert Myers Building Gate 14, Barker Street University of New South Wales, NSW 2052
Country
Australia
Secondary sponsor category [1] 256116 0
None
Name [1] 256116 0
Address [1] 256116 0
Country [1] 256116 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258858 0
VIHEC Human Research Ethics Committee
Ethics committee address [1] 258858 0
: Level 4, North Wing, Rupert Myers Building (RMB), Gate 14, Barker Street, The University of New South Wales SYDNEY NSW 2052
Ethics committee country [1] 258858 0
Australia
Date submitted for ethics approval [1] 258858 0
14/04/2010
Approval date [1] 258858 0
12/10/2010
Ethics approval number [1] 258858 0
1004

Summary
Brief summary
The primary purpose of the study is to assess microbial contamination of antibacterial contact lens cases when used in conjunction with marketed contact lenses worn on a daily wear and monthly replacement schedule and to compare the results to a historical control.
Hypothesis: antibacterial lens cases will have less contamination inside the lens storage case than a regular lens case
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31075 0
Mr Daniel Tilia
Address 31075 0
Level 5, North Wing, RMB, Gate 14, Barker Street, The University of New South Wales SYDNEY NSW 2052
Country 31075 0
Australia
Phone 31075 0
+61293857516
Fax 31075 0
Email 31075 0
d.tilia@brienholdenvision.org
Contact person for public queries
Name 14322 0
Mr Daniel Tilia
Address 14322 0
Level 5, North Wing, RMB, Gate 14, Barker Street, The University of New South Wales SYDNEY NSW 2052
Country 14322 0
Australia
Phone 14322 0
+612 9385 6165
Fax 14322 0
+612 9385 7401
Email 14322 0
d.tilia@brienholdenvision.org
Contact person for scientific queries
Name 5250 0
Mr Daniel Tilia
Address 5250 0
Level 5, North Wing, RMB, Gate 14, Barker Street, The University of New South Wales SYDNEY NSW 2052
Country 5250 0
Australia
Phone 5250 0
+612 9385 6165
Fax 5250 0
+612 9385 7401
Email 5250 0
d.tilia@brienholdenvision.org

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary