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Trial registered on ANZCTR
Registration number
ACTRN12608000609358
Ethics application status
Approved
Date submitted
11/11/2008
Date registered
4/12/2008
Date last updated
23/07/2009
Type of registration
Prospectively registered
Titles & IDs
Public title
Evaluation of tear lipid changes during daily wear of silicone hydrogel lenses and use of two lens disinfection solutions in 30 new and experienced contact lens wearing participants.
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Scientific title
Prospective, randomised, open label, contralateral, cross-over evaluation of tear lipid changes associated with daily wear of Acuvue Oasys and Purevision lenses used in conjunction with Aosept Plus and Optifree Replenish and correlation of findings with lens performance in up to 30 new and experienced contact lens wearers
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Contact Lens Wear
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Condition category
Condition code
Eye
4147
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Normal eye development and function
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
To investigate tear film lipid changes after contact lens wear and to correlate tear lipid changes after contact lens wear with lens performance. Participants will wear an Acuvue Oasys lens in one eye, comparing with the Purevision lens in the other eye. Participants will use one disinfection solution for the first month (randomised to either AoSept Plus or Optifree Replenish) and then cross over to the alternate disinfecting solution for the second month. Optifree Replenish (the intervention disinfection solution) is a multipurpose lens care solution which contains the antimicrobial agents polyquaternium-1 and myristamidopropyl dimethylamine. There will be a minimum of 2 calendar days (maximum 10 calendar days) wash-out period between the solution types.
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Intervention code [1]
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Prevention
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Comparator / control treatment
Active control (crossover). Aosept Plus solution, which is a hydrogen peroxide-based solution, will be the comparator.
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Control group
Active
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Outcomes
Primary outcome [1]
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To investigate tear film lipid changes after contact lens wear. To do this we will be collecting tears at every visit and assessing tear lipid levels using mass spectrometery.
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Assessment method [1]
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Timepoint [1]
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Assessments will occur on a fortnightly basis
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Secondary outcome [1]
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To correlate tear lipid changes after contact lens wear with lens performance. We will be collecting tears at every visit and assessing lipid levels. We will also be giving participants questionnaires at every visit, and assessing lens fit, vision and ocular health (i.e. redness, corneal staining) at every visit.
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Assessment method [1]
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Timepoint [1]
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Assessments will occur on a fortnightly basis
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Eligibility
Key inclusion criteria
Participants enrolled in the trial must:
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 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.
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Minimum age
18
Years
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Maximum age
N/A
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Participants enrolled in the trial must NOT have:
Pre-existing ocular irritation that would preclude contact lens fitting;
Known allergies to any of the ingredients in products tested;
An ocular condition that may preclude safe wearing of contact lenses;
An active corneal infection or any active ocular disease that would affect wearing of contact lenses;
A need for concurrent category S3 and above ocular medication up to 12 weeks prior to and during the trial;
Any systemic disease where fasting is contraindicated e.g. Type 1 diabetes, hypoglycaemia and any blood disorders (e.g. haemophilia)
Any systemic disease that may affect ocular health. Conditions such as systemic hypertension do not automatically exclude prospective participants;
Any systemic or topical medications up to 12 weeks prior to and during the trial that will affect ocular physiology or the performance of the lenses;
Had eye surgery within 12 weeks immediately prior to enrolment for this trial;
Undergone corneal refractive surgery;
Any ocular injury or condition (including keratoconus, herpes keratitis and orthokeratology) of the cornea, conjunctiva or eyelids that would affect the wearing of contact lenses;
Contraindications to contact lens wear;
Currently enrolled in another clinical trial or participated in contact lens clinical trial within 2 weeks;
Worn contact lenses for the past 2 weeks;
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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation table using computer software
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
One type of silicone hydrogel lens (eg Acuvue Oasys) will be randomised to one eye, the other eye will wear the other lens type (eg. Purevision). Then the solutions will be randomised - one solution be used in the first month, then the alternate solution will be issued in the second month.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
15/12/2008
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Institute for Eye Research
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Address [1]
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Level 5, Rupert Myers Building,
Gate 14, Barker St
University of New South Wales, Kensington, NSW, 2052
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Country [1]
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Australia
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Primary sponsor type
Charities/Societies/Foundations
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Name
Institute for Eye Research
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Address
Level 5, Rupert Myers Building,
Gate 14, Barker St
University of New South Wales, Kensington, NSW, 2052
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Vision Cooperative Research Centre and Institute for Eye Research Human Ethics Committee (VIHEC)
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Ethics committee address [1]
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Level 4, Rupert Myers Building,
Gate 14 Barker St
University of New South Wales, Kensington, NSW ,2052
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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Approval date [1]
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22/10/2008
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Ethics approval number [1]
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07/30
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Summary
Brief summary
Lipids form an outer layer of the tear film, which is essential in retarding evaporation of the aqueous layer of the tears. Contact lenses, after being inserted onto the eye, adsorb tear lipids. Analysis of tear lipid changes before and after contact lens wear may reveal which lipid component causes problems (in terms of ocular discomfort and inflammatory responses) with contact lens wear. The study hypothesis is that contact lens wear and/or lens care solutions change the tear lipid profile and thereby influence lens performance.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Jerome Ozkan
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Address
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Level 5, Rupert Myers Building,
Gate 14, Barker St
University of New South Wales, Kensington, NSW, 2052
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Country
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Australia
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Phone
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+61 2 9385 7516
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Fax
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+61 2 9385 7401
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Email
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[email protected]
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Contact person for scientific queries
Name
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Zhenjun Zhao
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Address
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Level 3, Rupert Myers Building,
Gate 14, Barker St
University of New South Wales, Kensington, NSW, 2052
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Country
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Australia
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Phone
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+61 2 9385 7593
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Fax
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+61 2 9385 7401
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Email
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[email protected]
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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.
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