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Trial registered on ANZCTR


Registration number
ACTRN12620001033932
Ethics application status
Approved
Date submitted
8/09/2020
Date registered
12/10/2020
Date last updated
31/08/2023
Date data sharing statement initially provided
12/10/2020
Date results provided
31/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial to assess the visual performance of multifocal contact lenses when worn by adults who have age-related problems with their focussing.
Scientific title
Prospective, single-masked (participant), randomised, crossover, bilateral wear, dispensing trial to assess the visual performance of monthly multifocal contact lenses in presbyopes.
Secondary ID [1] 302260 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Presbyopia 318986 0
Condition category
Condition code
Eye 316956 316956 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will be a prospective, bilateral, randomized, single-masked (participant), cross-over clinical trial. Participants will wear three different multifocal contact lenses (two control and one test). All contact lenses will be worn on a daily-wear basis for one month, with overnight disinfection utilising a commercially available multipurpose solution. All contact lens materials are commercially available in Australia. Test contact lenses are a centre-near design available in two reading additions. Two control lenses will be used. One control utilises a centre-near design and is available in three reading additions. The centre-near designs of test and control lenses are different. The other control utilises a combination of centre-distance / centre-near designs and is available in four near additions for each design.
The distance power of each contact lens will be matched to correct the participant’s distance ametropia.
Each participant will attend 4 visits, comprising visit 1 (baseline and first lens fitting), visit 2 (first lens assessment and second lens fitting), visit 3 (second lens assessment and third lens fitting), and visit 4 (third lens assessment). Visit 1 will be approximately 90 minutes duration, visits 2-3 approximately 60 minutes, and visit 4 approximately 30 minutes.
Visit 1 will comprise standard subjective refraction and near addition calculation. Distance visual acuity will be measured with subjective refraction using a standard logMAR visual acuity chart, and near visual acuity with be measured with subjective refraction plus near addition using a standard logMAR visual acuity chart. The anterior eye will be assessed with a slit lamp biomicroscope, which is a specialised microscope specifically used to observe the eye. The first randomly allocated lens will be fitted, and lens powers will be optimised for each participant. The final optimised lens will be dispensed.
Visits 2-3 will comprise participants attending while wearing allocated lenses. Visual acuities will be measured at both distance and near using standard logMAR visual acuity charts. Subjective performance will be assessed via a numeric rating scale for vision and comfort. A Likert scale will be used to assess lens handling. Both the numeric rating scales and Likert scale used in this study are non-validated metrics. Lens fitting will be assessed on eye using standard optometric techniques (slit lamp biomicroscopy) and nomenclature (lens centration, movement, and tightness). Contact lenses will be removed and the ocular surface will be assessed using standard optometric techniques (slit lamp biomicroscopy) and nomenclature (validated Efron 0-4 grading scales). Used contact lenses will be discarded and unused contact lenses will be collected. The next randomly allocated lens will be fitted, and lens powers will be optimised for each participant. The final optimised lens will be dispensed.
Visit 4 will comprise participants attending while wearing their final allocated lenses. Visual acuities, subjective performance, lens handling, lens fitting, and the ocular surface will be assessed using the same techniques as per visits 2-3. Used contact lenses will be discarded and unused contact lenses will be collected.
All contact lenses will be prescribed, and all assessments will be carried out by an optometrist.
Participants will be instructed to wear allocated study lenses to each visit and to return all unused lenses.
There is no ‘wash-out’ period between treatments.
Compliance will be assessed by verbal questioning of the participant.
Intervention code [1] 318550 0
Treatment: Devices
Comparator / control treatment
1. Commercially-available centre near multifocal contact lenses available in three near additions.

2. Commercially-available combination centre-distance / centre-near designs available in four near additions for each design.
Control group
Active

Outcomes
Primary outcome [1] 325056 0
Difference between test and control lenses for subjective visual performance. Participants will be asked to rate their vision with each contact lens on a non-validated 1-100 numeric rating scale.
Timepoint [1] 325056 0
Visit 2 (approximately 1-month post enrolment - primary timepoint).
Visit 3 (approximately 2-months post enrolment - primary timepoint).
Visit 4 (approximately 3-months post enrolment - primary timepoint).
Secondary outcome [1] 386696 0
Difference between test and control lenses for subjective comfort. Participants will be asked to rate their comfort with each contact lens on a non-validated 1-100 numeric rating scale
Timepoint [1] 386696 0
Visit 2 (approximately 1-month post enrolment).
Visit 3 (approximately 2-months post enrolment).
Visit 4 (approximately 3-months post enrolment).
Secondary outcome [2] 386697 0
Difference between test and control lenses for lens handling. Participants will be asked to rate their lens handling with each contact lens on a non-validated 4 point Likert scale.
Timepoint [2] 386697 0
Visit 2 (approximately 1-month post enrolment).
Visit 3 (approximately 2-months post enrolment).
Visit 4 (approximately 3-months post enrolment).
Secondary outcome [3] 386698 0
Difference between test and control lenses for visual acuity at distance and near. Visual acuity will be measured using standard logMAR visual acuity charts.
Timepoint [3] 386698 0
Visit 2 (approximately 1-month post enrolment).
Visit 3 (approximately 2-months post enrolment).
Visit 4 (approximately 3-months post enrolment).
Secondary outcome [4] 386699 0
Difference between test and control lenses for lens fitting. Lens fitting will be assessed using standard optometric techniques (slit lamp biomicroscopy) and nomenclature (centration, movement, and tightness).
Timepoint [4] 386699 0
Visit 2 (approximately 1-month post enrolment).
Visit 3 (approximately 2-months post enrolment).
Visit 4 (approximately 3-months post enrolment).
Secondary outcome [5] 386701 0
Difference between test and control lenses for ocular surface variables. Ocular surface will be assessed using standard optometric techniques (slit lamp biomicroscopy) and nomenclature (validated Efron 0-4 grading scale).
Timepoint [5] 386701 0
Visit 2 (approximately 1-month post enrolment).
Visit 3 (approximately 2-months post enrolment).
Visit 4 (approximately 3-months post enrolment).

Eligibility
Key inclusion criteria
Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
Age 40 and above, male or female.
Willing to comply with the clinical trial protocol as directed by the Investigator.
Agree not to participate in other clinical research for the duration of this clinical trial.
Have ocular health findings considered to be “normal” and which would not prevent the participant from safely wearing contact lenses.
Contact lens wear experience in the past 5 years.
Best corrected spectacle acuity of at least 6/7.5.
Have no more than 1.00 D of astigmatism.
Can be fitted with multifocal soft contact lenses within the power range available.
Able to obtain a binocular contact lens high contrast visual acuity of at least 6/7.5 with study contact lenses.
Willing and able to wear each study contact lens for about one month on a daily wear basis, for at least 5 days per week and 7 hours per day.
Minimum age
40 Years
Maximum age
No limit
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, immunosuppressive 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.
Corneal distortion resulting from previous hard or rigid lens wear or keratoconus.
Use of or a need for concurrent category S3 and above ocular medication at enrolment.
Eye surgery within 12 weeks immediately prior to enrolment for this trial.
Previous corneal refractive surgery or cataract surgery.
Contraindications to contact lens wear.
Known allergy or intolerance to ingredients in any of the clinical trial products.
Currently enrolled in another contact lens or lens care solution clinical trial within the last two weeks.
Currently wearing one of the contact lenses used in the study.
Pregnancy* or lactating at time of enrolment.
The Investigator may, at their 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 enough.

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 not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Assuming the mean difference ± SD between designs = 10 ± 15 units on a 0-100 numeric rating scale in 1-point steps for subjective vision variables, and assuming 5% significance, a sample size of 25 participants who complete the trial will have > 80 % power to allow comparisons between test and control contact lenses.
Numeric rating scale, visual acuity, lens fitting, and ocular gradings will be summarised as means ± standard deviations. Data transformation will be performed prior to analysis if required. Outcomes will be compared between test and control lens types. The significance of the lens designs will be determined for each visit using repeated effects linear mixed model with subject random intercepts which accounts for the repeated effects within a participant. If the overall effect is significant, post hoc multiple comparisons will be adjusted using Bonferroni correction. If the assumptions of data normality are not met, Wilcoxon signed-rank test may be used.
Likert variables will be treated as categorical and summarised as percentages. Differences between test and controls will be assessed with chi-squared test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/11/2020
Actual
4/11/2020
Date of last participant enrolment
Anticipated
1/03/2021
Actual
5/03/2021
Date of last data collection
Anticipated
1/06/2021
Actual
4/06/2021
Sample size
Target
26
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 31188 0
2019 - Botany

Funding & Sponsors
Funding source category [1] 306682 0
Commercial sector/Industry
Name [1] 306682 0
Menicon Co. Ltd., Japan
Country [1] 306682 0
Japan
Primary sponsor type
Commercial sector/Industry
Name
Menicon Co. Ltd., Japan
Address
3-21-19, Aoi, Naka-ku,
Nagoya, Aichi 460-0006
Country
Japan
Secondary sponsor category [1] 307234 0
Commercial sector/Industry
Name [1] 307234 0
nthalmic Pty Ltd
Address [1] 307234 0
Suite L2 Level 3 Lakes Business Park
2A Lord Street
Botany NSW 2019
Country [1] 307234 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306860 0
Bellberry Limited
Ethics committee address [1] 306860 0
Ethics committee country [1] 306860 0
Australia
Date submitted for ethics approval [1] 306860 0
04/09/2020
Approval date [1] 306860 0
27/10/2020
Ethics approval number [1] 306860 0
2020-09-844

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

Contacts
Principal investigator
Name 105262 0
Mr Daniel Tilia
Address 105262 0
nthalmic Pty Ltd.
Suite L2 Level 3 Lakes Business Park
2A Lord Street Botany NSW 2019
Country 105262 0
Australia
Phone 105262 0
+61 2 9037 7700
Fax 105262 0
Email 105262 0
[email protected]
Contact person for public queries
Name 105263 0
Kathleen Laarakkers
Address 105263 0
nthalmic Pty Ltd.
Suite L2 Level 3 Lakes Business Park
2A Lord Street Botany NSW 2019
Country 105263 0
Australia
Phone 105263 0
+61 2 9037 7700
Fax 105263 0
Email 105263 0
[email protected]
Contact person for scientific queries
Name 105264 0
Daniel Tilia
Address 105264 0
nthalmic Pty Ltd.
Suite L2 Level 3 Lakes Business Park
2A Lord Street Botany NSW 2019
Country 105264 0
Australia
Phone 105264 0
+61 2 9037 7700
Fax 105264 0
Email 105264 0
[email protected]

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


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.