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Trial registered on ANZCTR
Registration number
ACTRN12615001337561
Ethics application status
Approved
Date submitted
4/12/2015
Date registered
8/12/2015
Date last updated
8/09/2016
Type of registration
Prospectively registered
Titles & IDs
Public title
Clinical trial to assess the visual performance of prototype contact lenses for astigmatism
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Scientific title
Prospective, single-masked, bilateral wear, crossover, clinical trial to assess visual performance of prototype contact lens designs for astigmatism compared to commercial contact lenses
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Secondary ID [1]
288027
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None
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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:
Astigmatism
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Condition category
Condition code
Eye
297124
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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
Participants will wear a prototype(test) soft contact lens for astigmatism bilaterally. An optometrist will fit participants with the assigned study lens and check its performance prior to dispensing lenses to participants. Participants will wear each lens for a minimum of 3 days in a week (up to 7 days a week) consistent with the participant's usual amount of contact lens wear. Up to two take home questionnaires will be completed on one time point between days 2-6 (depending on the number of days contact lenses are worn) . Between each lens type, there will be a washout period of 2 nights. To monitor adherence, participants will return unused lenses and foils of used lenses.
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Intervention code [1]
293385
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Treatment: Devices
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Comparator / control treatment
There will be two controls. Both are commercially available soft contact lenses. The controls are 1 Day Acuvue Moist (Johnson & Johnson ) and Biofinity Toric (CooperVision). Controls will be worn on a daily wear, daily disposable basis
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Control group
Active
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Outcomes
Primary outcome [1]
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Visual Acuity using LogMAR chart
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Assessment method [1]
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Timepoint [1]
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Day 0 (at time of dispense) and Day X (assessment visit)
Where 3< X < 7 days.
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Primary outcome [2]
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Contrast sensitivity using Pelli-Robson chart equivalent
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Assessment method [2]
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Timepoint [2]
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Day 0 (at time of dispense); Day X (assessment visit)
Where 3< X < 7 days.
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Secondary outcome [1]
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Subjective ratings from participants comparing prototype contact lenses and commercial control using numerical scales
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Assessment method [1]
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Timepoint [1]
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Day 0 (at time of dispense); Day X where 0<X<7 (take-home questionnaire); Day 7 (assessment visit)
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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.
* Have astigmatism between -0.75 D and -2.00D.
* 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.
* Correctable to at least 6/12 (20/40) or better in each eye with contact lenses.
* Be suitable and willing to wear contact lenses
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Minimum age
18
Years
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Maximum age
40
Years
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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
* 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, Sjögrens 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. However, ocular medication can be prescribed during the course of the trial as per standard optometric practice.
* 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.
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Study design
Purpose of the study
Treatment
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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)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
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Type of endpoint/s
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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
8/02/2016
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Actual
16/02/2016
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Date of last participant enrolment
Anticipated
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Actual
11/05/2016
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Date of last data collection
Anticipated
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Actual
10/06/2016
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Sample size
Target
35
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Accrual to date
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Final
27
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Brien Holden Vision Pty Ltd
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Address [1]
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Level 3, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
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Country [1]
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Brien Holden Vision Pty Ltd
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Address
Level 3, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney 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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Bellberry Limited
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Ethics committee address [1]
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129 Glen Osmond Road, Eastwood, South Australia, 5063
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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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07/12/2015
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Approval date [1]
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27/01/2016
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Ethics approval number [1]
293972
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Summary
Brief summary
This is a clinical trial to assess the visual performance of a new (prototype) soft contact lens for astigmatism compared to commercially available soft contact lenses. Astigmatism is a common eye condition where images at all distances can be blurred to variation in the shape of the surface of the eye. To assess the visual performance we wish to monitor your eyes' response to the products and what you think of them.
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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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Mr Danny Kho
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Address
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Brien Holden Vision Institute
Level 5 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney 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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Email
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[email protected]
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Contact person for public queries
Name
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Mr Danny Kho
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Address
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Brien Holden Vision Institute
Level 5 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney 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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Email
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[email protected]
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Contact person for scientific queries
Name
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Mr Danny Kho
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Address
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Brien Holden Vision Institute
Level 5 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney 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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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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