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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.
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
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contact Lens Wear 3953 0
Condition category
Condition code
Eye 4147 4147 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 3667 0
Prevention
Comparator / control treatment
Active control (crossover). Aosept Plus solution, which is a hydrogen peroxide-based solution, will be the comparator.
Control group
Active

Outcomes
Primary outcome [1] 5043 0
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.
Timepoint [1] 5043 0
Assessments will occur on a fortnightly basis
Secondary outcome [1] 8487 0
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.
Timepoint [1] 8487 0
Assessments will occur on a fortnightly basis

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.
Minimum age
18 Years
Maximum age
N/A
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation table using computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
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.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/12/2008
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] 4137 0
Charities/Societies/Foundations
Name [1] 4137 0
Institute for Eye Research
Country [1] 4137 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Institute for Eye Research
Address
Level 5, Rupert Myers Building,
Gate 14, Barker St
University of New South Wales, Kensington, NSW, 2052
Country
Australia
Secondary sponsor category [1] 3722 0
None
Name [1] 3722 0
Address [1] 3722 0
Country [1] 3722 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6207 0
Vision Cooperative Research Centre and Institute for Eye Research Human Ethics Committee (VIHEC)
Ethics committee address [1] 6207 0
Level 4, Rupert Myers Building,
Gate 14 Barker St
University of New South Wales, Kensington, NSW ,2052
Ethics committee country [1] 6207 0
Australia
Date submitted for ethics approval [1] 6207 0
Approval date [1] 6207 0
22/10/2008
Ethics approval number [1] 6207 0
07/30

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29110 0
Address 29110 0
Country 29110 0
Phone 29110 0
Fax 29110 0
Email 29110 0
Contact person for public queries
Name 12267 0
Jerome Ozkan
Address 12267 0
Level 5, Rupert Myers Building,
Gate 14, Barker St
University of New South Wales, Kensington, NSW, 2052
Country 12267 0
Australia
Phone 12267 0
+61 2 9385 7516
Fax 12267 0
+61 2 9385 7401
Email 12267 0
[email protected]
Contact person for scientific queries
Name 3195 0
Zhenjun Zhao
Address 3195 0
Level 3, Rupert Myers Building,
Gate 14, Barker St
University of New South Wales, Kensington, NSW, 2052
Country 3195 0
Australia
Phone 3195 0
+61 2 9385 7593
Fax 3195 0
+61 2 9385 7401
Email 3195 0
[email protected]

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

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