The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615000652572
Ethics application status
Approved
Date submitted
5/06/2015
Date registered
24/06/2015
Date last updated
14/02/2017
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 compared to commercial contact lenses
Secondary ID [1] 286866 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Presbyopia 295266 0
Condition category
Condition code
Eye 295513 295513 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. Participants will attend separate fitting and assessment visits for each lens type (Fitting Visit on Day 1, and Assessment Visit on Day 7 at the latest, but may be as early as 6 hours after the Fitting Visit). There will be a minimum 24 hour 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 +6 to -10 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.

Up to 25 contact lens designs will be tested in the study, however each individual participant will test a maximum of 10 prototype designs. 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] 292041 0
Treatment: Devices
Comparator / control treatment
Participants will test at least 1 commercially available contact lens as a control for up to a week. The control lenses are 1-Day Acuvue Moist, 1-Day Acuvue Moist Multifocal, Dailies Aqua Comfort Plus, Dailies Aqua Comfort Plus Multifocal, Biotrue ONEday for Presbyopia, Clariti 1 Day Multifocal, SEED 1dayPure moisture Multistage, Proclear Multifocal and MiSight. All will be worn on a daily disposable modality.

There will be a minimum 1 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] 295246 0
Visual acuity, measured at distance with a computerised LogMAR chart and at near with a near LogMAR chart.
Timepoint [1] 295246 0
Up to 1 week after lens fitting.
Secondary outcome [1] 315184 0
Subjective rating of vision will be assessed for each pair of lenses with a questionnaire based on a 1-10 scale. The questionnaire has been designed specifically for this study.
Timepoint [1] 315184 0
Up to 1 week after lens fitting.
Secondary outcome [2] 315274 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] 315274 0
Up to 1 week after lens fitting
Secondary outcome [3] 315275 0
Willingness to purchase the lenses assessed with a yes/no response questionnaire. The questionnaire has been designed specifically for this study.
Timepoint [3] 315275 0
Up to 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 at least 18 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 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
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. 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)
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.

Participants are stratified into the presbyope group or non-presbyope group depending on their add requirement, and the order in which they test lenses will be randomised.
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 administering the treatment/s

Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A minimum of 10 participants in each arm of the study (presbyope and non-presbyope) are required in order to demonstrate a statistically significant paired difference between the control lenses and each iteration in visual acuity of 0.1 +/-0.1 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 within an arm.

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. Analysis will be performed within each study arm namely presbyopes and non-presbyopes.

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. Analysis will be performed within each study arm namely presbyopes and non-presbyopes.

When a family of test lens designs are compared to the control, the best design within the family for each participant is selected prior to paired analysis. This design is selected by computing the average of subjective ratings of distance, intermediate, near and overall vision satisfaction for each participant. The design that maximises this computed average is selected for the family type paired analysis compared to controls.

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
Recruitment postcode(s) [1] 9787 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 291424 0
Commercial sector/Industry
Name [1] 291424 0
Brien Holden Vision Pty Ltd
Address [1] 291424 0
Level 4, North Wing, Rupert Myers Building, Gate 14, Barker Street, UNSW Sydney NSW 2052
Country [1] 291424 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] 290101 0
None
Name [1] 290101 0
Address [1] 290101 0
Country [1] 290101 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292977 0
Bellberry Limited
Ethics committee address [1] 292977 0
129 Glen Osmond Road, Eastwood
South Australia 5063
Ethics committee country [1] 292977 0
Australia
Date submitted for ethics approval [1] 292977 0
Approval date [1] 292977 0
02/06/2015
Ethics approval number [1] 292977 0
2015-04-256

Summary
Brief summary
To assess visual performance of multiple optimised prototype soft contact lens designs compared to commercially available contact lenses
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57870 0
Ms Jennifer Sha
Address 57870 0
Brien Holden Vision Institute, Level 5 North Wing, Rupert Myers Building, Gate 14, Barker Street, UNSW, Sydney NSW 2052
Country 57870 0
Australia
Phone 57870 0
+61293859811
Fax 57870 0
Email 57870 0
j.sha@brienholdenvision.org
Contact person for public queries
Name 57871 0
Ms Kassandra Wagenfuehr
Address 57871 0
Brien Holden Vision Institute, Level 5 North Wing, Rupert Myers Building, Gate 14, Barker Street, UNSW, Sydney NSW 2052
Country 57871 0
Australia
Phone 57871 0
+61293855934
Fax 57871 0
Email 57871 0
k.wagenfuehr@brienholdenvision.org
Contact person for scientific queries
Name 57872 0
Ms Jennifer Sha
Address 57872 0
Brien Holden Vision Institute, Level 5 North Wing, Rupert Myers Building, Gate 14, Barker Street, UNSW, Sydney NSW 2052
Country 57872 0
Australia
Phone 57872 0
+61293859811
Fax 57872 0
Email 57872 0
j.sha@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