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Trial registered on ANZCTR


Registration number
ACTRN12617000819325
Ethics application status
Approved
Date submitted
31/05/2017
Date registered
5/06/2017
Date last updated
19/11/2018
Date data sharing statement initially provided
19/11/2018
Date results information initially provided
19/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of a new contact lens design against two prototype designs and a commercially-available single vision design
Scientific title
Prospective, double-masked, bilateral wear, crossover, dispensing clinical trial to compare the visual performance between a new commercially-available contact lens design which utilise digital zone optics, prototype contact lens designs which utilise higher-order spherical aberrations to increase depth-of-focus and a commercially-available single vision contact lens
Secondary ID [1] 292093 0
None
Universal Trial Number (UTN)
Trial acronym
The DZO Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 303511 0
Condition category
Condition code
Eye 302926 302926 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will be a prospective, bilateral, randomised, double-masked, cross-over clinical trial.
Participants will wear four lens types for 5 consecutive days on a single-use, daily wear basis with a minimum two day wash-out between lens types. The four lens types comprise:
Commercially-available single vision lenses made from comfilcon A: Base curve = 8.6 mm, Diameter = 14 mm, Power Range = -0.75 to -6.00 D
Commercially-available lenses utilizing digital zone optics made from comfilcon A: Base curve = 8.6 mm, Diameter = 14 mm, Power Range = -0.75 to -6.00 D
Two prototype extended depth of focus (EDOF) which utilize deliberate manipulation of multiple higher-order spherical aberrations terms to extend depth of focus made from Poly-HEMA material. Base curve = 8.4 mm, Diameter = 14 mm, Power Range = -0.75 to -6.00 D
Minimum wearing time will be 5 days and 6 hours/day with no maximum wearing time provided lenses are not slept in overnight.
There will 9 visits comprising Baseline and two visits for each of the 4 lens designs (Fitting and Assessment). Each visit will be approximately 45 minutes in duration.
Baseline visits will comprise auto-refraction, subjective refraction with visual acuity measurement and ocular assessment with a slit-lamp biomicroscope (a specialized microscope for viewing the eye).
Fitting visits will be performed by unmasked investigators and comprise contact lens fitting, assessment of contact lens visual acuity and assessment of contact lenses on eye with a slit-lamp biomicroscope (a specialized microscope for viewing the eye).
Assessment visits will be performed by masked investigators and comprise assessment of contact lens visual acuity, distance and near heterophoria, monocular accommodative facility and subjective ratings of vision questionnaire utilizing a 1-10 numeric rating scale, and the validated Computer Vision syndrome Questionnaire.
In between Fitting and Assessment visits, participants will complete a subjective ratings of vision take-home questionnaire utilizing a 1-10 numeric rating scale.
A minimum 2-day wash-out will be observed between Fitting and Assessment visits where study lenses are not worn. Participants will wear their habitual vision correction in between wearing study lenses
All contact lenses will be prescribed and all assessments will be carried out by an optometrist. Participants will be instructed to return all unused contact lenses.
Intervention code [1] 298235 0
Treatment: Devices
Comparator / control treatment
Active control (single vision comfilcon A lenses)- crossover study
Control group
Active

Outcomes
Primary outcome [1] 302319 0
Visual acuity: This will be assessed using electronic logMAR charts at 6 m, 70 cm and 40 cm.
Timepoint [1] 302319 0
All 4 assessment visits
Secondary outcome [1] 335468 0
Subjective ratings of vision: These will be assessed with a questionnaire utilising numeric rating scales (1-10 in 1-point steps) which assess clarity of vision and ghosing at distance, intermediate and near, vision when driving during day time and night time and overall vision satisfaction.
Timepoint [1] 335468 0
All 4 midpoints between Fitting and Assessment visits
Secondary outcome [2] 335469 0
Subjective ratings of vision: These will be assessed with a questionnaire utilising numeric rating scales (1-10 in 1-point steps) which assess clarity of vision and ghosing at distance, intermediate and near, vision when driving during day time and night time and overall vision satisfaction.
Timepoint [2] 335469 0
All 4 Assessment Visits
Secondary outcome [3] 335550 0
Distance heterophoria: This will be assessed with a Distance Howell Phoria Card at 3 m
Timepoint [3] 335550 0
All 4 Assessment Visits.
Secondary outcome [4] 335551 0
Near monocular accommodative facility: This will be assessed with +/-2.00 D flip spheres at 33 cm, with the left eye occluded.
Timepoint [4] 335551 0
All 4 Assessment Visits.
Secondary outcome [5] 335552 0
Presence of computer vision sydrome: This will be assessed with the validated Compuer Vision Syndrom Questionnaire.
Timepoint [5] 335552 0
All 4 Assessment Visits.

Eligibility
Key inclusion criteria
Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
Be between 18-40 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.
Is myopic and correctable to at least 6/12 (20/40) or better in each eye with contact lenses.
Be suitable and willing to wear contact lenses.
Minimum age
18 Years
Maximum age
40 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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.
Pregnancy*.
The Investigator may, at his/her discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant’s best interests.
*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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created through www.randomization.com
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Crossover
Other design features
None
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size: A minimum of 30 participants are required in order to demonstrate a statistically significant paired difference between lens designs in visual acuity of 0.1 +/- 0.15 logMAR units and subjective ratings of 1 +/- 1.8 units at the 5% level of significance and 80% power. The sample size of 30 participants is adjusted for a low drop out of 10%.

Analysis: Visual acuity will be recorded on a logMAR scale. Data will be summarised as means +/- standard deviations. No transformation is likely to be required. Visual acuity will be compared between each lens design and control lens types. The significance of lens design will be determined for each visit. Repeated effects linear mixed model with subject random intercepts or paired t tests will be employed for the analysis of visual acuity.

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)
NSW

Funding & Sponsors
Funding source category [1] 296624 0
Other
Name [1] 296624 0
Brien Holden Vision Institute
Address [1] 296624 0
Level 5, Rupert Myers Building Gate 14, Barker
Street University of New South Wales, NSW
2052
Country [1] 296624 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Brien Holden Vision Institute
Address
Level 4, Rupert Myers Building Gate 14, Barker
Street University of New South Wales, NSW
2052
Country
Australia
Secondary sponsor category [1] 295588 0
None
Name [1] 295588 0
Address [1] 295588 0
Country [1] 295588 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297857 0
Bellberry Limited
Ethics committee address [1] 297857 0
129 Glen Osmond Rd
Eastwood
South Australia 5063
Ethics committee country [1] 297857 0
Australia
Date submitted for ethics approval [1] 297857 0
08/05/2017
Approval date [1] 297857 0
06/06/2017
Ethics approval number [1] 297857 0

Summary
Brief summary
The purpose of this study is to compare the visual performance (defined by visual acuity measurements and subjective ratings0 between a new commercially-available contact lens design which utilise digital zone optics (DZO), two prototype Extended Depth-of-Focus (EDOF) contact lens designs which utilise higher-order spherical aberration terms and a commercially-available single vision contact lens (SV).
To achieve this, participants will wear each of the 4 lens designs for a minimum of 5 days. Outcome measures will comprise visual acuity and subjective ratings.
Our hypotheses are there will be no difference between lens designs for either visual acuity or subjective ratings.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75282 0
Mr Daniel Tilia
Address 75282 0
Level 5, Rupert Myers Building Gate 14, Barker
Street University of New South Wales, NSW
2052
Country 75282 0
Australia
Phone 75282 0
+61293857516
Fax 75282 0
+61293857401
Email 75282 0
d.tilia@brienholdenvision.org
Contact person for public queries
Name 75283 0
Mr Daniel Tilia
Address 75283 0
Level 5, Rupert Myers Building Gate 14, Barker
Street University of New South Wales, NSW
2052
Country 75283 0
Australia
Phone 75283 0
+61293857516
Fax 75283 0
+61293857401
Email 75283 0
d.tilia@brienholdenvision.org
Contact person for scientific queries
Name 75284 0
Mr Daniel Tilia
Address 75284 0
Level 5, Rupert Myers Building Gate 14, Barker
Street University of New South Wales, NSW
2052
Country 75284 0
Australia
Phone 75284 0
+61293857516
Fax 75284 0
+93857401
Email 75284 0
d.tilia@brienholdenvision.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will not published. However trial results, recorded as group means plus/minus
SD and their statistical analysis may be published in scientific journals or conferences.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary