Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001897257
Ethics application status
Approved
Date submitted
13/11/2018
Date registered
22/11/2018
Date last updated
20/06/2019
Date data sharing statement initially provided
22/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
NaturalVue Multifocal Benchmarking Trial
Scientific title
Prospective, double-masked, randomized, crossover, bilateral wear
dispensing trial to assess visual performance of NaturalVue Multifocal
lenses against EDOF lenses
Secondary ID [1] 296584 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Presbyopia 310395 0
Condition category
Condition code
Eye 309113 309113 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant will wear NaturalVue Multifocal lenses and prototype EDOF lenses bilaterally for minimum 7 days (minimum 8 hours per day) with a minimum 2-night wash-out period between lens types.
Both lens types are multifocal lenses which assist with correcting a range of vision from distance to near.
In the middle of the wear period, participants will complete a questionnaire while wearing the lenses. Also at the assessment visit at the end of the wear period, participants will be asked how many days they wore the lenses and average number of hours per day of wearing the lenses.
Intervention code [1] 312896 0
Treatment: Devices
Comparator / control treatment
NaturalVue Multifocal
Control group
Active

Outcomes
Primary outcome [1] 308089 0
Visual acuity at 6 metres with an electronic high-contrast logMAR vision chart,
Timepoint [1] 308089 0
After minimum 7 days of lens wear
Secondary outcome [1] 353912 0
Subjective rating of overall vision satisfaction with a 1-10 numerical rating scale
Timepoint [1] 353912 0
After minimum 7 days of lens wear

Eligibility
Key inclusion criteria
Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
Be presbyopic and at least 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 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
40 Years
Maximum age
80 Years
Sex
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. 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)
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 type for each participant. The generated randomisation list will be copied from the website by the biostatistician and applied through the Clinic Data Management system.
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
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / 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 test 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 test 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
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Change in management, decision to change research focus areas
Date of first participant enrolment
Anticipated
4/02/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 301165 0
Commercial sector/Industry
Name [1] 301165 0
Brien Holden Vision Institute
Country [1] 301165 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Brien Holden Vision Institute
Address
Brien Holden Vision Institute
Level 4, Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 300786 0
None
Name [1] 300786 0
Address [1] 300786 0
Country [1] 300786 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301909 0
Bellberry Limited
Ethics committee address [1] 301909 0
Ethics committee country [1] 301909 0
Australia
Date submitted for ethics approval [1] 301909 0
19/10/2018
Approval date [1] 301909 0
15/02/2018
Ethics approval number [1] 301909 0

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

Contacts
Principal investigator
Name 88522 0
Ms Jennifer Sha
Address 88522 0
Brien Holden Vision Institute
Level 5, Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Country 88522 0
Australia
Phone 88522 0
+61 2 93857537
Fax 88522 0
Email 88522 0
j.sha@brienholdenvision.org
Contact person for public queries
Name 88523 0
Belinda Ludlow
Address 88523 0
Brien Holden Vision Institute
Level 5, Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Country 88523 0
Australia
Phone 88523 0
+61 2 93857537
Fax 88523 0
Email 88523 0
b.ludlow@brienholdenvision.org
Contact person for scientific queries
Name 88524 0
Jennifer Sha
Address 88524 0
Brien Holden Vision Institute
Level 5, Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Country 88524 0
Australia
Phone 88524 0
+61 2 93857537
Fax 88524 0
Email 88524 0
j.sha@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


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.