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Trial registered on ANZCTR


Registration number
ACTRN12615000725561
Ethics application status
Approved
Date submitted
16/06/2015
Date registered
15/07/2015
Date last updated
8/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective, contralateral lens wear, randomised, controlled, 3-months clinical trial to test the efficacy and safety of a surface modified contact lens during continuous wear modality.
Scientific title
A prospective, contralateral lens wear, randomised, controlled, 3-months clinical trial to test the efficacy and safety of a surface modified contact lens during continuous wear modality.
Secondary ID [1] 286925 0
NHMRC Development APP1076206
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ocular inflammation and infection related to contact lens wear 295348 0
Condition category
Condition code
Eye 295617 295617 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of the performance of antimicrobial melimine coated contact lenses to standard marketed contact lenses with 2 week extended wear basis. Subjects will wear a test melimine coated antimicrobial lens in one eye, and the control uncoated marketed lens in the other eye (extended wear means uninterrupted day and night wear). The contact lens material is same, Etafilcon A. The total duration for innervation is 3 months and will include total 7 study visits that will confirm the adherence to intervention protocols. After the study finishes, subjects will be followed up after 1 month (with own spectacles/contact lenses) to rule out any delayed effects.
Intervention code [1] 292116 0
Prevention
Comparator / control treatment
This is a contralateral study. Which means participants will be wearing antimicrobial (test) contact lens in one eye and commercially available control contact lenses in the other eye (randomly allocated). So, the eye with control contact lens will serve as the control treatment.
Control group
Active

Outcomes
Primary outcome [1] 295331 0
Ocular health of subjects, evaluated by detailed slit lamp examinations, ocular signs and symptoms.
Timepoint [1] 295331 0
Assessed after 1 day, 2 weeks, 1 month, 3 months and 4 months
Secondary outcome [1] 315367 0
To demonstrate the safety of surface-modified lens wear (e.g. no increases in bulbar/limbal redness, corneal/conjunctival staining during lens wear compared to control lenses)
Timepoint [1] 315367 0
Throughout the study
Secondary outcome [2] 315368 0
To explore retention of anti-adhesion activity of surface-modified lenses against bacteria in the laboratory after 2 weeks of wear. Worn contact lenses will be collected aseptically at the end of lens wear and will be checked in the laboratory to assess its retention of antimicrobial activity.
Timepoint [2] 315368 0
3 months visit,
Secondary outcome [3] 315369 0
To examine changes to the normal cultivable microbiota of the conjunctiva during the lens wear. Worn contact lenses will be collected in a sterile vial from participants using sterile gloves. Contact lens collection will follow the standard contact lens removal procedure from eye. Eye swabs will be collected from the eyes following the standard ocular swabbing technique. Participants will be asked to look down and the exposed white of the eye will be gently rubbed using a sterile cotton bud pre-moistened with sterile saline.
Timepoint [3] 315369 0
3 months visit

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, male or female.
*Willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator.
*Have vision that is correctable to at least 6/12 (20/40) or better in each eye with contact lenses/spectacles.
*Require contact lens correction in each eye between -0.75 and -6.00 D inclusive.
Minimum age
18 Years
Maximum age
No limit
Sex
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’s 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 any therapeutic ocular medication at enrolment (that would be required to be discontinued during the study);
*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.
*Eye surgery within 12 weeks immediately prior to enrolment for this trial.
*Previous corneal refractive surgery.
*Known allergy or intolerance to ingredients in any of the study products.
*Currently enrolled in another clinical trial or participation in a clinical trial within the previous 2 weeks.
*Pregnancy or lactating (Testing of pregnancy is not required. A participant’s verbal report is sufficient).

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 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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2016
Actual
1/02/2016
Date of last participant enrolment
Anticipated
Actual
1/06/2017
Date of last data collection
Anticipated
Actual
1/09/2017
Sample size
Target
175
Accrual to date
Final
175
Recruitment outside Australia
Country [1] 6982 0
India
State/province [1] 6982 0
Telengana

Funding & Sponsors
Funding source category [1] 291487 0
Government body
Name [1] 291487 0
NH&MRC
Country [1] 291487 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Level 3 School of Optometry and Vision Scinece
RMB North Gate 14 Barker St NSW-2032, Australia
Country
Australia
Secondary sponsor category [1] 290162 0
None
Name [1] 290162 0
Address [1] 290162 0
Country [1] 290162 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293030 0
University of New South Wales
Ethics committee address [1] 293030 0
Ethics committee country [1] 293030 0
Australia
Date submitted for ethics approval [1] 293030 0
02/07/2015
Approval date [1] 293030 0
14/08/2015
Ethics approval number [1] 293030 0

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

Contacts
Principal investigator
Name 58146 0
Prof Mark DP Willcox
Address 58146 0
School of Optometry and Vision Science, University of New South Wales
Level 3 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Country 58146 0
Australia
Phone 58146 0
+61293854164
Fax 58146 0
Email 58146 0
m.willcox@unsw.edu.au
Contact person for public queries
Name 58147 0
Debarun Dutta
Address 58147 0
School of Optometry and Vision Science, University of New South Wales
Level 3 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Country 58147 0
Australia
Phone 58147 0
+61293854503
Fax 58147 0
Email 58147 0
debarun.dutta@unsw.edu.au
Contact person for scientific queries
Name 58148 0
Debarun Dutta
Address 58148 0
School of Optometry and Vision Science, University of New South Wales
Level 3 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Country 58148 0
Australia
Phone 58148 0
+61293854503
Fax 58148 0
Email 58148 0
debarun.dutta@unsw.edu.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
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Documents added automatically
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