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Trial registered on ANZCTR


Registration number
ACTRN12612000370808
Ethics application status
Approved
Date submitted
27/03/2012
Date registered
30/03/2012
Date last updated
23/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Global Aberration Study - measuring global higher order aberrations and retinal image quality of commercial contact lenses with the EyeMapper.
Scientific title
A prospective, single-masked (participant only), contralateral, single-group, controlled, balanced block design, non-dispensing clinical trial measuring global higher order aberrations and retinal image quality of commercial contact lenses with the EyeMapper.
Secondary ID [1] 280119 0
N/A
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Higher order aberration profile and retinal image quality. 286040 0
Condition category
Condition code
Eye 286391 286391 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in this cross over study will wear 17 randomly allocated, commercially available contact lenses (maximum 4 lens types per visit) over 5 visits. Each visit is approximately 1.5 hours in duration where each lens type will be worn for 40 minutes contralaterally. An overnight washout between visits is required. Higher order aberration profile will be measured with the EyeMapper. The EyeMapper is a non-invasive novel instrument designed to measure refractive errors and higher order abberations of the eye over wide angles of view.
Intervention code [1] 284550 0
Treatment: Devices
Comparator / control treatment
At the Basline visit (Visit 1), control lens (Lotrafilcon B) to be worn in both eyes for approximately 40 minutes and then lenses will be removed.
Control group
Active

Outcomes
Primary outcome [1] 286816 0
To compare the global higher order aberrations between different commercial contact lenses
Timepoint [1] 286816 0
Aberration profile measurements will be carried out with a non-invasive novel instrument (EyeMapper) at all 5 scheduled visits. For each lens type, aberration measurement will take approximately 20 minutes.
Secondary outcome [1] 296723 0
To compare the global retinal image quality between different commercial contact lenses
Timepoint [1] 296723 0
Retinal image quality measurements will be carried out with a non-invasive novel instrument (EyeMapper) at all 5 scheduled visits. For each lens type, retinal image quality measurements will take approximately 20 minutes.

Eligibility
Key inclusion criteria
Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
Be 18 to 35 years old, male or female.
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 a prescription that is myopic between -0.25 to -4.00D (inclusive).
May have astigmatism that is not greater than -1.00DC.
Be experienced or inexperienced at wearing contact lenses
Minimum age
18 Years
Maximum age
35 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any pre-existing ocular irritation, injury or condition (including infection or disease) 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 auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjogrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.
Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial.
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 or beneficial manner at enrolment and/or during the clinical trial.

NB: Systemic antihistamines are allowed on an “as needed basis”, provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used.

Eye surgery within 12 weeks immediately prior to enrolment for this trial.
Previous corneal refractive surgery.
Contraindications to contact lens wear.
Known allergy or intolerance to ingredients in any of the clinical trial products.
Currently enrolled in another clinical trial.
Participation in a clinical trial within the previous 2 weeks for long-term studies and 48 hours between short-term studies.
Pregnancy*.

*Formal testing of pregnancy is not required. A participant’s verbal report is sufficient.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The planned number of participants is a minimum of 40. Enrolment will take place over approximately 2 months.

Participants will be screened for general clinical trial suitability by way of a routine eye examination which includes refraction, visual acuity and general eye health. Informed consent will be obtained prior to any clinical trial procedures. Both experienced contact lens wearers and neophytes (participants with no prior lens wear experience) will be enrolled into lens wear.

The order of administering the various contact lens designs will be randomised for all participants. Concealed allocation will be by way of central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The control lens will not be randomised, it will be tested bilaterally on both eyes in the first stage.
All other 16 test lens types will be divided into groups of 4. Each group of 4 lens types will be tested on the same stage. The four lens types within each stage will be randomly allocated based on a randomization plan generated at www.randomization.com. The random sequence will be generated to create a random permutation of lens types where each participant receives all the 4 lens types in random order.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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)

Funding & Sponsors
Funding source category [1] 284970 0
Charities/Societies/Foundations
Name [1] 284970 0
Brien Holden Vision Institute
Address [1] 284970 0
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country [1] 284970 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Brien Holden Vision Institute
Address
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 283837 0
None
Name [1] 283837 0
Address [1] 283837 0
Country [1] 283837 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286975 0
Bellberry Limited
Ethics committee address [1] 286975 0
229 Greenhill Road
Dulwich
South Australia 5065
Ethics committee country [1] 286975 0
Australia
Date submitted for ethics approval [1] 286975 0
Approval date [1] 286975 0
02/03/2012
Ethics approval number [1] 286975 0
2012-02-653

Summary
Brief summary
The aim of this study is to assess the impact of commercial contact lenses on the global peripheral aberrations and retinal image quality.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33904 0
Address 33904 0
Country 33904 0
Phone 33904 0
Fax 33904 0
Email 33904 0
Contact person for public queries
Name 17151 0
Jerome Ozkan
Address 17151 0
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country 17151 0
Australia
Phone 17151 0
+61 2 9585 7516
Fax 17151 0
Email 17151 0
j.ozkan@brienholdenvision.org
Contact person for scientific queries
Name 8079 0
Ravi Bakaraju
Address 8079 0
Level 4, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country 8079 0
Australia
Phone 8079 0
+61 2 9585 7516
Fax 8079 0
Email 8079 0
r.bakaraju@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