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Trial registered on ANZCTR


Registration number
ACTRN12613000369729
Ethics application status
Approved
Date submitted
29/03/2013
Date registered
8/04/2013
Date last updated
26/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the clinical performance and retention of antimicrobial activity of melimine coated contact lenses
Scientific title
A prospective, randomized, double masked, contralateral clinical trial to investigate the clinical performance and retention of antimicrobial activity of melimine coated contact lenses.
Secondary ID [1] 281851 0
CRTC-2013-01
Universal Trial Number (UTN)
U1111-1138-9797
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clinical performance of antimicrobial contact lens wear. 288225 0
Condition category
Condition code
Eye 288588 288588 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of the performance of antimicrobial melimine contact lenses to standard marketed contact lenses with 1 week extended wear basis. Subjects will wear a test antimicrobial lens in one eye, and the control marketed lens in the other eye (extended wear means uninterrupted day and night wear). Participants will be wearing same set of lenses. The duration for innervation is 1 week and will include total 4 study visits that will confirm the adherence to intervention protocols. After the study finishes, subjects will be followed up after 1 week and 4 weeks (with own spectacles/contact lenses) to rule out any delayed effects.
Intervention code [1] 286826 0
Prevention
Comparator / control treatment
Marketed lenses will be worn overnight on a 1 week extended wear basis (extended wear means uninterrupted day and night wear). Participants be wearing the same set of contact lenses for the 1 week. Similar to the intervention duration of control is 1 week.
Control group
Active

Outcomes
Primary outcome [1] 289194 0
Ocular health of subjects, evaluated by detailed slit lamp examinations, ocular signs and symptoms.
Timepoint [1] 289194 0
assessed after 2 hours, 1 day and at the end of the study (1 week)
Secondary outcome [1] 302009 0
To determine whether melimine coated lenses retain antibacterial efficacy after wear; evaluated by laboratory testing of retention of activity
Timepoint [1] 302009 0
Lenses will be assessed on after each week of wear.
Secondary outcome [2] 303149 0
Well being of the eye health; Additional follow ups will help to rule out any delayed toxicity. Standard vision screening and detail ocular examination will be carried out including slit lamp bio-microscopy.
Timepoint [2] 303149 0
4 weeks after the last study visit

Eligibility
Key inclusion criteria
Subjects enrolled in the trial must:
Be able to read, comprehend and give informed consent as demonstrated by signing a record of informed consent.
Be at least 18 years old.
Be willing and able to comply with the lens wearing and clinical trial visit schedule as directed by the by the Investigator.
Have ocular health findings considered as “normal” and which would not prevent the subject from safely wearing contact lenses.
Have vision correctable to at least 6/12 (20/40) or better in each eye with spherical 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?
No
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 autoimmune 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;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; N.B. Systemic antihistamines are allowed on an ‘as needed basis’, provided they are not used prophylactically during the trial; Contraindications to contact lens wear;

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)
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 receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Test lens in one eye, control lens in the other eye
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Approximately 20 participants are required in order to demonstrate a statistically significant difference in corneal staining score of 0.5 ± 0.7 at the 5% level of significance and 80% power. The sample size is adjusted for a 15 % dropout rate.

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)
NSW

Funding & Sponsors
Funding source category [1] 286972 0
Charities/Societies/Foundations
Name [1] 286972 0
Brien Holden Vision Institute
Address [1] 286972 0
Rupert Myers Building, University of New South Wales, Sydney, NSW-2033
Country [1] 286972 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Brien Holden Vision Institute
Address
Rupert Myers Building, University of New South Wales, Sydney, NSW-2033
Country
Australia
Secondary sponsor category [1] 285763 0
None
Name [1] 285763 0
Address [1] 285763 0
Country [1] 285763 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289022 0
University of New South Wales, Human Research Ethics Committee (UNSW HREC)
Ethics committee address [1] 289022 0
Ethics Secretariat
UNSW Grants Management Office
Rupert Myers Building, Level 3, South Wing
The University of New South Wales
SYDNEY NSW 2052
Ethics committee country [1] 289022 0
Australia
Date submitted for ethics approval [1] 289022 0
02/04/2013
Approval date [1] 289022 0
30/04/2013
Ethics approval number [1] 289022 0

Summary
Brief summary
To determine whether contact lenses coated with melimine can be worn safely and prevent bacterial colonization of their surface. Both the dispensing optometrists and contact lens wearers will be masked.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37386 0
Prof Mark Willcox
Address 37386 0
School of Optometry and Vision Science
University of New South Wales
Sydney, NSW 2052
Country 37386 0
Australia
Phone 37386 0
+61293854164
Fax 37386 0
Email 37386 0
m.willcox@unsw.edu.au
Contact person for public queries
Name 37387 0
Mr Debarun Dutta
Address 37387 0
Level -5, Ruper Myers Building - North Wing, Baker st, Gate-14, UNSW, Kensington, Sydney NSW 2033
Country 37387 0
Australia
Phone 37387 0
+61293857546
Fax 37387 0
Email 37387 0
d.dutta@brienholdenvision.org
Contact person for scientific queries
Name 37388 0
Mr Debarun Dutta
Address 37388 0
Level -5, Ruper Myers Building - North Wing, Baker st, Gate-14, UNSW, Kensington, Sydney NSW 2033
Country 37388 0
Australia
Phone 37388 0
+61293857546
Fax 37388 0
Email 37388 0
d.dutta@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