Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000447257
Ethics application status
Approved
Date submitted
28/05/2009
Date registered
12/06/2009
Date last updated
22/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Changes in ocular mucin expression due to contact lens wear
Scientific title
Prospective study investigating the change of ocular mucin expression on the ocular surface and in tear fluid due to contact lens wear and its correlation with contact lens clinical performance in neophytes and regular wearers with minimal lens wear in the previous one month.
Secondary ID [1] 259837 0
New secondary ID. Please modify.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contact lens wear affects mucin expression on the ocular surface and in tear fluid. The mucin change correlates with clinical variables and lens performance. 4870 0
Condition category
Condition code
Eye 237221 237221 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A prospective, randomised, contralateral lens wear, open label, single group design clinical trial. with participants wearing comercially available lenses (AIR OPTIX AQUA and PUREVISION) and lens care solution (AOSEPT PLUS). Lenses will be worn for one month and a minimum of 6 hours per day, 5 days per week, on a daily wear basis (i.e. removed prior to sleep). Lenses will be disinfected overnight (minimum of 6 hours) in the lens care solution.
Intervention code [1] 236652 0
Treatment: Devices
Comparator / control treatment
Changes in mucin expression after 1 month contralateral wear of two lens types will be compared to the initial visit (i.e. baseline visit) where no lenses are worn.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238035 0
To investigate mucin changes due to contact lens wear using impression cytology to permit collection and morphological examination of the superficial layers of the superior tarsal conjunctival epithelium. Samples will be taken prior to lens wear (i.e. baseline visit) and following 1 month of lens wear.
Timepoint [1] 238035 0
Baseline and 30 days after baseline
Secondary outcome [1] 242196 0
To determine whether there is a correlation between mucin changes and clinical performance or comfort of commercially available contact lenses. Qestionnaires will be used to asess subjective performance. Objective assessment of the eyes wiill be conducted with a slit-lamp biomicroscope (including corneal and conjunctival staining fluorecein).
Timepoint [1] 242196 0
Baseline then 1, 2 and 30 days after baseline.

Eligibility
Key inclusion criteria
Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;
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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Regular contact lens wearers;
Pre-existing ocular irritation that would preclude contact lens fitting;
Any ocular condition that may preclude safe wearing of contact lenses e.g. active corneal infection, severe dry eye, reduced corneal sensitivity, exophthalmos/lagophthalmos, facial nerve palsy;
Active corneal infection (bacterial, viral, fungal or protozoan) or any active ocular disease such as iritis, corneal edema or corneal dystrophies, including anterior membrane dystrophy that would affect wearing of contact lenses;
Use of any of the following medications (including steroids) up to 12 weeks prior to start of the clinical trial, or during the course of the trial:
Ocular medication, category S3 and above;
Any systemic or topical medications that will affect ocular physiology or the performance of the lenses e.g. anti-acne medications such as Roaccutane and corticosteroid or immunosuppressant medications such as Hydrocortisone, Prednisolone;
Any systemic disease that may affect ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankolysing spondylitis, multiple sclerosis, Sjogrens syndrome and systemic lupus erythematosis;
Conditions such as systemic hypertension do not automatically exclude prospective participants;
Eye surgery within 12 weeks immediately prior to enrolment for this trial;
Previous corneal refractive surgery;
Any ocular injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids that would affect the wearing of contact lenses;
Contraindications to hydrogel contact lens wear;
Currently enrolled in another clinical trial;.
Be pregnant or breast feeding;*.
Allergy or intolerance to topical anaesthetics.
*verbal report of pregnancy by the participant is sufficient, formal testing not required

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. 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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
12/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 5034 0
Charities/Societies/Foundations
Name [1] 5034 0
Institute for Eye Research
Country [1] 5034 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Institute for Eye Research
Address
Level 5, Rupert Myers Building
Gate 14, Barker Street,
University of New South Wales, SYDNEY NSW 2052
Country
Australia
Secondary sponsor category [1] 4550 0
None
Name [1] 4550 0
Address [1] 4550 0
Country [1] 4550 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239139 0
The University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 239139 0
Ethics committee country [1] 239139 0
Australia
Date submitted for ethics approval [1] 239139 0
Approval date [1] 239139 0
10/01/2008
Ethics approval number [1] 239139 0
07310

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

Contacts
Principal investigator
Name 29659 0
Address 29659 0
Country 29659 0
Phone 29659 0
Fax 29659 0
Email 29659 0
Contact person for public queries
Name 12906 0
Jerome Ozkan
Address 12906 0
Level 5, Rupert Myers Building
Gate 14, Barker Street,
University of New South Wales, SYDNEY NSW 2052
Country 12906 0
Australia
Phone 12906 0
+61 2 93857516
Fax 12906 0
+61 2 93857401
Email 12906 0
j.ozkan@ier.org.au
Contact person for scientific queries
Name 3834 0
Mark Willcox
Address 3834 0
Level 4, Rupert Myers Building
Gate 14, Barker Street,
University of New South Wales, SYDNEY NSW 2052
Country 3834 0
Australia
Phone 3834 0
+61 2 93857516
Fax 3834 0
+61 2 93857401
Email 3834 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.