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Trial registered on ANZCTR


Registration number
ACTRN12620001034921
Ethics application status
Approved
Date submitted
8/09/2020
Date registered
12/10/2020
Date last updated
8/06/2021
Date data sharing statement initially provided
12/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial to assess the visual performance of astigmatic contact lenses in young adults who are short-sighted
Scientific title
Prospective, randomised, crossover, bilateral wear, masked dispensing trial to assess the visual performance of astigmatic contact lenses in myopic, adult, contact lens wearers
Secondary ID [1] 302246 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 318963 0
Condition category
Condition code
Eye 316933 316933 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 up to 6 different test contact lens designs and one control contact lens. All contact lenses will be worn on a daily-wear basis for one week. All test lenses are toric and the control lens is a commercially available dual-focus lens.
The distance power of each contact lens will be matched to correct the participant’s myopia.
Each participant will attend for a maximum of 8 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), visit 4 (third lens assessment and fourth lens fitting), visit 5 (fourth lens assessment and fifth lens fitting), visit 6 (fifth lens assessment and sixth lens fitting), visit 7 (sixth lens assessment, seventh lens fitting) and visit 8 (seventh lens assessment). Visit 1 will be approximately 90 minutes duration, visits 2-7 approximately 60 minutes, and visit 8 approximately 30 minutes.
Visit 1 will comprise standard subjective refraction and measurement of visual acuity obtained with refraction. A standard logMAR visual acuity chart will be used. Power-matched spherical contact lenses will be fitted with a view to obtaining the distance lens power that will be initially used to fit all test and control lenses. The first allocated lens will be dispensed.
Visits 2-7 will comprise participants attending while wearing allocated lenses. Visual acuity will be measured, and visual performance will be assessed via a numeric rating scale. A standard logMAR visual acuity chart will be used to measure visual acuity, and the numeric rating scale used in this study is a non-validated metric. Used contact lenses will be discarded and unused contact lenses will be collected. The next randomly allocated lens will be dispensed.
Visit 8 will comprise participants attending while wearing randomly allocated lenses. Visual acuity will be measured, and visual performance will be assessed. Both procedures will be performed using the same techniques used in visits 2-7. 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] 318541 0
Treatment: Devices
Comparator / control treatment
Dual-focus contact lenses.
Control group
Active

Outcomes
Primary outcome [1] 325051 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] 325051 0
Visit 2: (approximately 1-week post-enrolment - primary timepoint).
Visit 3: (approximately 2 weeks post-enrolment - primary timepoint).
Visit 4: (approximately 3 weeks post-enrolment - primary timepoint).
Visit 5: (approximately 4 weeks post-enrolment - primary timepoint).
Visit 6: (approximately 5 weeks post-enrolment - primary timepoint).
Visit 7: (approximately 6 weeks post-enrolment - primary timepoint).
Visit 8: (approximately 7 weeks post-enrolment - primary timepoint).
Secondary outcome [1] 386675 0
Difference between test and control lenses for visual acuity. Visual acuity will be measured with a standard logMAR chart at 6 m.
Timepoint [1] 386675 0
Visit 2: (approximately 1-week post-enrolment).
Visit 3: (approximately 2 weeks post-enrolment).
Visit 4: (approximately 3 weeks post-enrolment).
Visit 5: (approximately 4 weeks post-enrolment).
Visit 6: (approximately 5 weeks post-enrolment).
Visit 7: (approximately 6 weeks post-enrolment).
Visit 8: (approximately 7 weeks 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.
Be at least 18 years of age but less than 40 years of age, male or female.
Willing to comply with the clinical trial 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.
Have experience with wearing contact lenses.
Have myopia greater than 0.75 D and no more than 6.00 D.
Have best-corrected visual acuity at least 6/7.5.
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.
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 while wearing study lenses.
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 at time of enrolment—verbal report sufficient.
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.

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
All test lenses will be compared to the control lens. To demonstrate a statistically significant paired difference of 10 ± 15 units on a 0-100 numeric rating scale between a test lens and control lens requires a minimum of 22 participants at the 5% level of significance and 80% power. This sample size is adjusted for a 10% drop-out.
Primary and secondary outcomes will be summarised as means ± standard deviation. Variables will be compared between the control and each test lens using parametric paired t-tests if the assumptions of data normality are not violated. Otherwise, Wilcoxon signed-rank test will be used.
Multiple comparisons between all lens types will be assessed with descriptive statistics.

Recruitment
Recruitment status
Recruiting
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] 31185 0
2019 - Botany

Funding & Sponsors
Funding source category [1] 306668 0
Commercial sector/Industry
Name [1] 306668 0
nthalmic Pty Ltd
Address [1] 306668 0
Suite L2 Level 3 Lakes Business Park
2A Lord Street
Botany NSW 2019
Country [1] 306668 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
nthalmic Pty Ltd
Address
Suite L2 Level 3 Lakes Business Park
2A Lord Street
Botany NSW 2019
Country
Australia
Secondary sponsor category [1] 307233 0
None
Name [1] 307233 0
Address [1] 307233 0
Country [1] 307233 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306848 0
Bellberry Limited
Ethics committee address [1] 306848 0
123 Glen Osmond Rd
Eastwood
South Australia 5063
Ethics committee country [1] 306848 0
Australia
Date submitted for ethics approval [1] 306848 0
02/09/2020
Approval date [1] 306848 0
22/10/2020
Ethics approval number [1] 306848 0
2020-07-661

Summary
Brief summary
The purpose of this trial is to assess the visual performance of astigmatic contact lenses compared to dual-focus contact lenses.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105218 0
Mr Daniel Tilia
Address 105218 0
nthalmic Pty Ltd.
Suite L2 Level 3 Lakes Business Park
2A Lord Street Botany NSW 2019
Country 105218 0
Australia
Phone 105218 0
+61 2 9037 7700
Fax 105218 0
Email 105218 0
d.tilia@nthalmic.com
Contact person for public queries
Name 105219 0
Ms Kathleen Laarakkers
Address 105219 0
nthalmic Pty Ltd.
Suite L2 Level 3 Lakes Business Park
2A Lord Street Botany NSW 2019
Country 105219 0
Australia
Phone 105219 0
+61 2 9037 7700
Fax 105219 0
Email 105219 0
k.laarakkers@nthalmic.com
Contact person for scientific queries
Name 105220 0
Mr Daniel Tilia
Address 105220 0
nthalmic Pty Ltd.
Suite L2 Level 3 Lakes Business Park
2A Lord Street Botany NSW 2019
Country 105220 0
Australia
Phone 105220 0
+61 2 9037 7700
Fax 105220 0
Email 105220 0
d.tilia@nthalmic.com

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 other documents available
Summary results
No Results