Trial Review

ANZCTR is currently experiencing a technical issue. Thank you for your patience while we work on it and apologies for any inconvenience caused.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

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
ACTRN12624000383561
Ethics application status
Approved
Date submitted
26/02/2024
Date registered
2/04/2024
Date last updated
27/05/2025
Date data sharing statement initially provided
2/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Can eye drops safely replace reading glasses in older adults?
Scientific title
Investigating the effects of long-term pilocarpine use for presbyopia treatment on posterior ocular structures
Secondary ID [1] 311574 0
Nil known
Universal Trial Number (UTN)
U1111-1304-5173
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Presbyopia 332950 0
Retinal ischaemia 332951 0
Condition category
Condition code
Eye 329663 329663 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a prospective, two-way cross-over clinical trial consisting of two 3-month treatment blocks. Participants will be randomly allocated to either receive the intervention or control in the first treatment block.

The study intervention is Pilocarpine hydrochloride 12.5 mg/mL (1.25%) eye drops. Participants allocated to receive the intervention in the first treatment block will be given these eye drops to administer one drop twice daily in both eyes, in place of wearing their reading glasses or contact lenses, for a period of 3 months (i.e. the duration of a treatment block).

Participants allocated to receive the control in the first treatment block will not receive the intervention, and wear their reading glasses or contact lenses, for a period of 3 months (i.e. the duration of a treatment block).

After the first 3-month treatment block, there will be a 2-week 'wash out' period during which no participants will administer the eye drop intervention and all participants will wear their reading glasses or contact lenses (control). After this 'wash out' period, participants will cross-over to the opposite treatment for the next 3-month treatment block (i.e. those who received the intervention in the first treatment block will wear their reading glasses or contact lenses, while those who received the control will be given the intervention eye drops to administer one drop up to twice daily in both eyes, in place of wearing their reading glasses or contact lenses).

Every week during each 3-month treatment block, participants will be asked to estimate their adherence to their allocated treatment over the previous 7-day period. At select time points, participants will also be asked to complete a questionnaire about their near vision function, spectacle independence, and satisfaction with the allocated treatment. At the end of the trial, participants will be asked which of the treatments they preferred using to manage their presbyopia.
Intervention code [1] 328027 0
Treatment: Drugs
Intervention code [2] 328028 0
Diagnosis / Prognosis
Comparator / control treatment
Participants will serve as their own control. The standard treatment for presbyopia is via optical correction (with glasses and/or contact lenses), outcome measures obtained under standard optical correction (control) will be compared to under instillation of eye drops (intervention) for presbyopia treatment.

When participants are allocated to receive the control treatment, they will be instructed to wear their standard reading glasses or contact lenses for a period of 3-months (i.e. the duration of a treatment block).
Control group
Active

Outcomes
Primary outcome [1] 337462 0
Change in choroidal thickness. Measurements of subfoveal choroidal thickness
Timepoint [1] 337462 0
Baseline, end of first treatment block (3 months), end of 2-week washout (3.5 months), then end of second treatment block (6.5 months)
Secondary outcome [1] 431983 0
Change in chorioretinal vascular and perfusion density. Vascular density can be divided into several components: superficial capillary plexus (SCPs), deep capillary plexus (DCP), and choriocapillaris (CC), but will be assessed together as a composite outcome
Timepoint [1] 431983 0
Baseline, end of first treatment block (3 months), end of 2-week washout (3.5 months), then end of second treatment block (6.5 months)
Secondary outcome [2] 432065 0
Change in patient-reported outcomes on near visual acuity.
Timepoint [2] 432065 0
Baseline, and Weeks 1, 6, and 12 of each 3-month treatment block.
Secondary outcome [3] 433344 0
Change in choroidal thickness. Measurements of peripheral choroidal thickness
Timepoint [3] 433344 0
Baseline, end of first treatment block (3 months), end of 2-week washout (3.5 months), then end of second treatment block (6.5 months)
Secondary outcome [4] 433345 0
Change in amplitude and latency of the global flash multifocal electroretinogram (gmfERG) waveform components. These outcomes are measured at different retinal eccentricities for both direct and induced retinal responses.
Timepoint [4] 433345 0
Baseline, end of first treatment block (3 months), end of 2-week washout (3.5 months), then end of second treatment block (6.5 months)
Secondary outcome [5] 448115 0
Change in retinal thickness. The standardised Early Treatment Diabetic Retinopathy Study (ETDRS) grid allows for the measurement of the thicknesses of all individual retinal layers at different retinal eccentricities.
Timepoint [5] 448115 0
Baseline, end of first treatment block (3 months), end of 2-week washout (3.5 months), then end of second treatment block (6.5 months)
Secondary outcome [6] 448116 0
Change in patient-reported outcomes on spectacle independence.
Timepoint [6] 448116 0
Baseline, and every week during each 3-month treatment block.
Secondary outcome [7] 448117 0
Change in patient-reported outcomes on near vision satisfaction
Timepoint [7] 448117 0
Baseline, and every week during each 3-month treatment block.
Secondary outcome [8] 448118 0
Change in patient-reported outcomes on near vision correction preference
Timepoint [8] 448118 0
At study conclusion (i.e. at the end of the second treatment block, 6.5 months)

Eligibility
Key inclusion criteria
Healthy adults who only wear optical correction (glasses and/or contact lenses) for presbyopia correction, and are willing and able to provide written informed consent for study participation.
Minimum age
40 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Medical conditions
- Uncontrolled systemic disease or clinically significant disease state in any body system that, in the opinion of the investigator, could have affected the safety of the individual or interpretation of endpoint measures
- History of ocular pathology or intraocular surgery that, in the opinion of the investigator, could have affected the safety of the individual or interpretation of endpoint measures

Contraindications for Vuity eye drops
- Known allergy or sensitivity to pilocarpine, other components in Vuity eye drops, or other cholinergic agonist medications
- Narrow iridocorneal angles that are at risk of angle-closure and physiological anisocoria of >1 mm between pupils, as these conditions could affect the safety of the individual or interpretation of endpoint measures

Prior/Concomitant therapy
- Use of any topical prescription or over-the-counter ophthalmic medications that, in the opinion of the investigator, could have a substantial effect on visual function and affect interpretation of endpoint measures
- Use of systemic medications with potential ocular side effects, including topiramate, hydroxychloroquine, ethambutol, phosphodiesterase 5 inhibitors (sildenafil, vardenafil, tadalafil), or tamoxifen, that could have a substantial effect on visual function and affect interpretation of endpoint measures
- Use of systemic or intranasal anticholinergics and alpha-adrenergic receptor agonists with potential pupillary or accommodative effects, including oxymetazoline, tetrahydrozoline, phenylephrine, naphazoline, atropine, pilocarpine, beta-blockers, or antihistamines, that could have a substantial effect on visual function and affect interpretation of endpoint measures
- Use of systemic maprotiline, tricyclic antidepressants, or monoamine oxidase inhibitors, that could have a substantial effect on visual function and affect interpretation of endpoint measures

Diagnostic assessments
- Ametropia, defined as refractive error based on non-cycloplegic subjective refraction with a spherical equivalent of less than 0.50 Dioptres in absolute value (that is, regardless of whether it is myopia or hyperopia). Additionally, it must have a maximum magnitude of astigmatism of 1.00 Dioptres. This way, clinically significant mixed astigmatisms, which could have a spherical equivalent within the range ± 0.50 Dioptres, are excluded. This is to exclude individuals who wear bifocal or multifocal glasses or contact lenses for habitual correction, as this may affect interpretation of endpoint measures
- Monocular best-corrected distance visual acuities poorer than 0.00 logMAR (Snellen 6/6) in both eyes, as this may be indicative of an underlying ocular condition or abnormality that may affect the safety of the individual or interpretation of endpoint measures

Other
- Females who are not pregnant or breastfeeding, and are not considering becoming pregnant or donating eggs during the study or for ~30 days after the last dose of study intervention, as safety of Vuity eye drops has not been established for use in pregnancy and lactation.

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)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
GraphPad Prism (GraphPad Software, San Diego, CA) and/or SPSS Statistics (IBM, Armonk, NY) will be used for conducting statistical analyses. All statistical tests will be two-tailed and at 5% significance level throughout the analyses. Summaries of continuous variables which are normally distributed will be presented as means and standard deviations or medians and inter-quartiles for skewed data, while categorical variables will be presented as frequencies and percentages. Paired t-test will be used to test for differences in endpoint measures between presbyopia correction with optical correction vs. pilocarpine eye drops. The assumption of normality of data will be assessed by visual inspection of Normal Q-Q plots and/or Shapiro-Wilk test of normality. Upon violation of the assumption of normality, a nonparametric Wilcoxon signed-rank test will be conducted instead of a paired t-test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2025
Actual
Date of last participant enrolment
Anticipated
1/06/2027
Actual
Date of last data collection
Anticipated
1/06/2028
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 26178 0
New Zealand
State/province [1] 26178 0
Auckland

Funding & Sponsors
Funding source category [1] 315873 0
Charities/Societies/Foundations
Name [1] 315873 0
The Association for Research in Vision and Ophthalmology
Country [1] 315873 0
United States of America
Funding source category [2] 319089 0
Charities/Societies/Foundations
Name [2] 319089 0
Freemasons Foundation
Country [2] 319089 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 318013 0
None
Name [1] 318013 0
Address [1] 318013 0
Country [1] 318013 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314721 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 314721 0
Ethics committee country [1] 314721 0
New Zealand
Date submitted for ethics approval [1] 314721 0
11/04/2024
Approval date [1] 314721 0
18/12/2024
Ethics approval number [1] 314721 0

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

Contacts
Principal investigator
Name 132518 0
Dr Alyssa Lie
Address 132518 0
School of Optometry and Vision Science The University of Auckland 85 Park Road, Grafton Auckland 1023
Country 132518 0
New Zealand
Phone 132518 0
+64 21 0266 4662
Fax 132518 0
Email 132518 0
[email protected]
Contact person for public queries
Name 132519 0
Alyssa Lie
Address 132519 0
School of Optometry and Vision Science The University of Auckland 85 Park Road, Grafton Auckland 1023
Country 132519 0
New Zealand
Phone 132519 0
+64 21 0266 4662
Fax 132519 0
Email 132519 0
[email protected]
Contact person for scientific queries
Name 132520 0
Alyssa Lie
Address 132520 0
School of Optometry and Vision Science The University of Auckland 85 Park Road, Grafton Auckland 1023
Country 132520 0
New Zealand
Phone 132520 0
+64 21 0266 4662
Fax 132520 0
Email 132520 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.