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Trial registered on ANZCTR


Registration number
ACTRN12614000063617
Ethics application status
Approved
Date submitted
8/01/2014
Date registered
20/01/2014
Date last updated
20/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Visual performance assessment of prototype contact lenses in children and young adults
Scientific title
Prospective, participant-masked, crossover dispensing clinical trial to assess visual performance of prototype contact lens designs compared to commercial contact lenses in children and young adults
Secondary ID [1] 283869 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 290853 0
Condition category
Condition code
Eye 291214 291214 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prospective, participant-masked, clinical trial where participants will wear prototype (test) and commercial (control) lenses bilaterally. Up to 6 contact lens designs will be assessed against commercial control lens. The 6 lens designs are the top performing designs based on the results of a non-dispensing pilot study, which assesses the short-term visual performance in adults. The designs differ by power variations across the lens surface. It is voluntary for all the participants to complete all six stages and no 'washout' is required between each stage. Participants will wear the lenses on a daily wear, daily disposable basis for up to 7 days before crossing over to the next lens design. Questionnaires will need to be completed on day 2, 4 and 6.
Intervention code [1] 288544 0
Treatment: Devices
Comparator / control treatment
The commercial control lens (AirOptix Aqua single vision, Alcon) will be worn on a daily wear, daily disposable basis for up to 7 days
Control group
Active

Outcomes
Primary outcome [1] 291207 0
Visual Acuity using LogMAR chart
Timepoint [1] 291207 0
Day 0 (at time of dispense); Day 7 (assessment visit)
Primary outcome [2] 291208 0
Contrast Sensitivity using Pelli-Robson chart or equivalent
Timepoint [2] 291208 0
Day 0 (at time of dispense); Day 7 (assessment visit)
Secondary outcome [1] 306231 0
Subjective ratings from participants comparing prototype contact lenses and commercial control using numerical scales and Likert scales
Timepoint [1] 306231 0
Day 0 (at time of dispense); Day 2/4/6 (take-home questionnaire); Day 7 (assessment visit)

Eligibility
Key inclusion criteria
*Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent or have a parent / guardian who is able to give informed consent on the participant’s behalf.
*Be between 7 and 18 years old (inclusive), 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.
*Correctable to at least 6/12 (20/40) or better in each eye with contact lenses.

Minimum age
7 Years
Maximum age
18 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 or strabismus surgery.
*Any binocular vision problems which may be exacerbated with the use of the study products or prevent adequate use of the device such as amblyopia, strabismus, excessive phoria and accommodative or convergence difficulties.
*Contraindications to contact lens wear.
*Known allergy or intolerance to ingredients in any of the clinical trial products

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
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)
NSW

Funding & Sponsors
Funding source category [1] 288514 0
Charities/Societies/Foundations
Name [1] 288514 0
Brien Holden Vision Institute
Address [1] 288514 0
Level 4, North Wing, RMB
Gate 14, Barker Street, University of New South Wales SYDNEY NSW 2052 AUSTRALIA
Country [1] 288514 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Brien Holden Vision Institute
Address
Level 4, North Wing, RMB
Gate 14, Barker Street, University of New South Wales SYDNEY NSW 2052 AUSTRALIA
Country
Australia
Secondary sponsor category [1] 287220 0
None
Name [1] 287220 0
Address [1] 287220 0
Country [1] 287220 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290378 0
Bellberry Limited
Ethics committee address [1] 290378 0
129 Glen Osmond Rd
Eastwood
South Australia 5063
Ethics committee country [1] 290378 0
Australia
Date submitted for ethics approval [1] 290378 0
Approval date [1] 290378 0
16/12/2013
Ethics approval number [1] 290378 0

Summary
Brief summary
Myopia (also known as near or short sightedness) is a condition of the eye where objects viewed in the distance appears blurred. Conventional methods of correcting this optical condition include spectacles and contact lenses. The rate of progression of myopia tends to be more rapid in the younger age and high degrees of myopia can lead to complications such as retinal degeneration and detachments, choroidal neovascular membranes and an increased risk of primary open angle glaucoma.

Numerous studies have investigated different contact lens optical designs to correct and potentially treat myopia. One theory in the attempt to reduce myopia progression is to target the stimulus on the peripheral retina. Previous studies have shown that the peripheral retinal stimulus plays a role in myopia progression. It is now known that peripheral hyperopia, where the stimulus or focus falls behind the retina, can be a trigger for myopia progression. Myopic eyes tend to have peripheral hyperopia and unfortunately the design of conventional spectacles and contact lenses used to correct myopia, actually exacerbates this.

Thus, in an attempt to minimise myopia progression, the optical design of contact lens should bring the focus from behind the retinal periphery to either on or in front of the retinal periphery. This concept has been tested in contact lenses previously and progression of myopia was found to be 34% less than when wearing spectacles only. Newer optical designs with this concept are required to be tested to enhance the myopic progression effect, however, as the lens designs are novel, myopic participants are required to test the lenses and ensure both vision and subjective acceptance of the lens prior to longer term assessments on the efficacy of these lenses.

Previously conducted clinical studies assessed numerous prototype lenses after short-term (1.5 and 6 hours) lens wear compared to commercially available equivalent contact lenses in adults. The best performing prototype lenses from the short-term trial have been selected for further testing in the current study against the best performing commercial contact lenses for use in children and young adults.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45390 0
Ms Pauline Xu
Address 45390 0
Brien Holden Vision Institute
Level 5, North Wing, RMB, Gate 14, Barker Street, University of New South Wales SYDNEY NSW 2052 AUSTRALIA
Country 45390 0
Australia
Phone 45390 0
+61 2 9385 9882
Fax 45390 0
Email 45390 0
p.xu@brienholdenvision.org
Contact person for public queries
Name 45391 0
Ms Elise Roberston
Address 45391 0
Brien Holden Vision Institute
Level 5, North Wing, RMB, Gate 14, Barker Street, University of New South Wales SYDNEY NSW 2052 AUSTRALIA
Country 45391 0
Australia
Phone 45391 0
+61 2 9385 7507
Fax 45391 0
Email 45391 0
e.robertson@brienholdenvision.org
Contact person for scientific queries
Name 45392 0
Ms Pauline Xu
Address 45392 0
Brien Holden Vision Institute
Level 5, North Wing, RMB, Gate 14, Barker Street, University of New South Wales SYDNEY NSW 2052 AUSTRALIA
Country 45392 0
Australia
Phone 45392 0
+61 2 9385 9882
Fax 45392 0
Email 45392 0
p.xu@brienholdenvision.org

No information has been provided regarding IPD availability
Summary results
No Results