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Trial registered on ANZCTR


Registration number
ACTRN12617000247370
Ethics application status
Approved
Date submitted
15/02/2017
Date registered
17/02/2017
Date last updated
25/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Dispensing study to assess the visual performance of optimised prototype contact lenses
Scientific title
Prospective, double-masked, bilateral wear, crossover dispensing clinical trial to assess visual performance of multiple optimised prototype contact lens designs which utilise higher-order spherical aberrations to increase depth-of-focus compared to commercial contact lenses
Secondary ID [1] 291174 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Presbyopia 302076 0
Myopia 302105 0
Condition category
Condition code
Eye 301707 301707 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Multiple prototype contact lens designs made from etafilcon A material will be assessed during the study, where each design will be worn daily for up to a week on a daily disposable modality. The prototype lenses are made from etafilcon A, with powers ranging from +3.00 to -6.00, base curve from 8.2mm to 8.7mm, and diameter from 13.8mm to 14.3mm.
Participants will attend separate fitting and assessment visits for each lens type (Fitting Visit on Day 1, and Assessment Visit on at least Day 7). There will be a minimum 2-night washout period between lens designs, i.e. after an assessment visit but
before the next fitting visit.
Prototype lenses all have a multifocal design and each design will be available in +3 to -6 dioptre powers. The difference between the prototype designs are in their manipulation of higher order spherical aberrations via their optics (i.e. differing power distribution throughout the lens), in order to achieve an increased depth of focus. Different manipulations can achieve either different or similar depths of focus. The power profiles of the prototype lenses feature multiple undulations with a smooth rise and fall of optical power as a function of optic cord diameter, and each of the prototype designs have variations of the undulations to provide different amounts of depth-of-focus.
Participants will test up to 5 prototype contact lens designs and at least 1 (maximum of 2) control lens (commercially available lens).
However, as participants are able to withdraw at any time, the final number of lenses tested by each participant is essentially determined by them.
Participants are asked to bring in any leftover lenses to the Assessment Visit as well as the foils of the lens blisters they open and use, to assist us in monitoring adherence.
Intervention code [1] 297188 0
Treatment: Devices
Comparator / control treatment
Participants will test at least 1 (maximum of 2) commercially available contact lens as a control for at least a week. The control lenses are 1-Day Acuvue Moist and 1-Day Acuvue Moist Multifocal. All will be worn on a daily disposable modality.
There will be a minimum 2-night washout period between lens designs.
Participants will attend separate visits at the beginning and end of each wear period.
Control group
Active

Outcomes
Primary outcome [1] 301105 0
Visual acuity, measured at distance with a computerised LogMAR chart and at near with a near LogMAR chart
Timepoint [1] 301105 0
At least 1 week after lens fitting
Secondary outcome [1] 331729 0
Subjective rating of vision will be assessed for each pair of lenses with a questionnaire based on a 1-10 scale. This questionnaire has been designed specifically for this study.
Timepoint [1] 331729 0
At least 1 week after lens fitting
Secondary outcome [2] 331730 0
Subjective rating of comfort assessed for each pair of lenses with a questionnaire on a 1-10 scale. The questionnaire has been designed specifically for this study.
Timepoint [2] 331730 0
At least 1 week after lens fitting.
Secondary outcome [3] 331731 0
Willingness to purchase the lenses assessed with a yes/no response questionnaire. The questionnaire has been designed specifically for this study.
Timepoint [3] 331731 0
At least 1 week after lens fitting

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 18-70 years old, male or female.
Have either presbyopia and/or myopia.
Have contact lens prescription between -6 to +3D.
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 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
70 Years
Sex
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. 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.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised to the order of testing lens designs. The randomisation plan will be generated from http://www.randomization.com/. The website's second random
generator will be used to create a random permutation of lens types for each participant.
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A minimum of 20 participants are required in order to demonstrate a statistically significant paired difference between the control lenses and each iteration in visual acuity of 0.1 +/- 0.15 logMAR units at the 5% level of significance and 80% power. The minimum sample size is a requirement at each stage of the cross over trial.
The sample size is not adjusted for drop outs due to the short nature of each stage. Participants will need to be replaced if drop outs occur.

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.

Subjective ratings will be recorded on a scale of 1 to 10 on steps of 1. Data will be summarised as means +/- standard deviations. No transformation is likely to be required. Subjective ratings 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 subjective ratings.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2017
Actual
4/07/2017
Date of last participant enrolment
Anticipated
30/03/2018
Actual
28/03/2018
Date of last data collection
Anticipated
Actual
19/04/2018
Sample size
Target
120
Accrual to date
Final
119
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 295616 0
Commercial sector/Industry
Name [1] 295616 0
Brien Holden Vision Pty Ltd
Country [1] 295616 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Brien Holden Vision Pty Ltd
Address
Level 4, North Wing, Rupert Myers Building, Gate 14, Barker Street, UNSW Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 294454 0
None
Name [1] 294454 0
Address [1] 294454 0
Country [1] 294454 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296935 0
Bellberry Limited
Ethics committee address [1] 296935 0
Ethics committee country [1] 296935 0
Australia
Date submitted for ethics approval [1] 296935 0
Approval date [1] 296935 0
13/02/2017
Ethics approval number [1] 296935 0
2016-12-887

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72482 0
Ms Jennifer Sha
Address 72482 0
Brien Holden Vision Institute, Level 5 North Wing, Rupert Myers Building,
Gate 14, Barker Street, UNSW, Sydney NSW 2052
Country 72482 0
Australia
Phone 72482 0
+61293859811
Fax 72482 0
Email 72482 0
[email protected]
Contact person for public queries
Name 72483 0
Kathy Laarakkers
Address 72483 0
Brien Holden Vision Institute, Level 5 North Wing, Rupert Myers Building,
Gate 14, Barker Street, UNSW, Sydney NSW 2052
Country 72483 0
Australia
Phone 72483 0
+61293857516
Fax 72483 0
Email 72483 0
[email protected]
Contact person for scientific queries
Name 72484 0
Jennifer Sha
Address 72484 0
Brien Holden Vision Institute, Level 5 North Wing, Rupert Myers Building,
Gate 14, Barker Street, UNSW, Sydney NSW 2052
Country 72484 0
Australia
Phone 72484 0
+61293859811
Fax 72484 0
Email 72484 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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