Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000508279
Ethics application status
Approved
Date submitted
29/03/2018
Date registered
9/04/2018
Date last updated
17/11/2020
Date data sharing statement initially provided
9/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Dose response measurements of low dose atropine eye drops over time
Scientific title
Dose response measurements of the pupils to 0.01%, 0.02% and 0.05% atropine eye drops over time in healthy adults.
Secondary ID [1] 294460 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 307216 0
Condition category
Condition code
Eye 306327 306327 0 0
Normal eye development and function
Eye 306328 306328 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1:
Drug Name: Atropine Sulphate
Dose: 1 drop of 0.01% atropine sulphate eye drops in each eye
Duration: Single Dose
Mode of administration: Topical eye drop instilled directly by researcher


Arm 2:
Drug Name: Atropine Sulphate
Dose: 1 drop of 0.02% atropine sulphate eye drops in each eye
Duration: Single Dose
Mode of administration: Topical eye drop instilled directly by researcher

Arm 3:
Drug Name: Atropine Sulphate
Dose: 1 drop of 0.05% atropine sulphate eye drops in each eye
Duration: Single Dose
Mode of administration: Topical eye drop instilled directly by researcher
Intervention code [1] 300753 0
Treatment: Drugs
Comparator / control treatment
Placebo Arm
Drug Name: None
Dose: 1 drop of vehicle (artificial tears) in each eye
Duration: Single Dose
Mode of administration: Topical eye drop instilled directly by researcher
Control group
Placebo

Outcomes
Primary outcome [1] 305336 0
Change in pupil size and responses as measured by a pupillometer
Timepoint [1] 305336 0
Baseline, 15 minutes post drop instillation, 30 minutes post drop instillation, 60 minutes post drop instillation (Primary time point), 360 minutes post drop instillation, 24 hours post drop instillation and 72 hours post drop instillation
Secondary outcome [1] 344887 0
Change in amplitude of accomodation as measured by push up tests
Timepoint [1] 344887 0
Baseline, 15 minutes post drop instillation, 30 minutes post drop instillation, 60 minutes post drop instillation, 360 minutes post drop instillation, 24 hours post drop instillation and 72 hours post drop instillation
Secondary outcome [2] 344888 0
Change in quality of vision as measured by the Quality of Vision Questionnaire
Timepoint [2] 344888 0
Baseline, 24 hours post drop instillation and 72 hours post drop instillation
Secondary outcome [3] 344889 0
Change in axial length as measured by IOLMaster
Timepoint [3] 344889 0
Baseline, 24 hours post drop instillation and 72 hours post drop instillation
Secondary outcome [4] 344890 0
Change in refractive error using autorefraction and subjective refraction
Timepoint [4] 344890 0
Baseline, 24 hours post drop instillation and 72 hours post drop instillation

Eligibility
Key inclusion criteria
1) Normal general and ocular health
2) Adults aged 18-40 years
3) No allergy to atropine or preservatives
4) No history or risk of glaucoma

Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Recent atropine eye drop use prior to enrolment
2) Any eye diseases including inflammation, infection or allergy
3) History of allergic reaction to eye medications
4) Risk of glaucoma
5) Currently using any eye medications or systemic monoamine oxidase inhibitors (MAOIs)
6) Women who are pregnant, planning to become pregnant or breastfeeding

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)
Numbered Containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
In previous studies, participants receiving 0.01% atropine eye drops experienced a change in pupil size from 3.89 mm to 5.02 mm, with a standard deviation of 0.92 mm. To be able to detect a difference of 1 standard deviation at 80% power and a significance of 0.05, a minimum sample size of 11 per concentration investigated is necessary. Assuming a dropout rate of 20%, our project aims to recruit 56 participants with 14 participants per concentration/control.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2018
Actual
23/08/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
56
Accrual to date
42
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 299083 0
University
Name [1] 299083 0
UNSW Sydney
Country [1] 299083 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
School of Optometry and Vision Science
UNSW Sydney
Gate 14, Barker St
Rupert Myers building (North Wing)
Kensington, NSW, 2033
Country
Australia
Secondary sponsor category [1] 298327 0
None
Name [1] 298327 0
Address [1] 298327 0
Country [1] 298327 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300020 0
UNSW Sydney Human Research Ethics Committee
Ethics committee address [1] 300020 0
UNSW Sydney
Gate 14, Barker St
Rupert Myers building (South Wing)
Kensington, NSW, 2033
Ethics committee country [1] 300020 0
Australia
Date submitted for ethics approval [1] 300020 0
03/04/2018
Approval date [1] 300020 0
11/05/2018
Ethics approval number [1] 300020 0
HC180207

Summary
Brief summary
Atropine eye drops are known to affect pupil reactions and the ability of the eyes to focus on near objects. This study will quantify the effects of different concentrations of atropine eye drops on these ocular structures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82282 0
Dr Alex Hui
Address 82282 0
School of Optometry and Vision Science
UNSW Sydney
Gate 14, Barker St
Rupert Myers building (North Wing)
Kensington, NSW, 2033
Country 82282 0
Australia
Phone 82282 0
+61 2 9385 9228
Fax 82282 0
Email 82282 0
[email protected]
Contact person for public queries
Name 82283 0
Dr Alex Hui
Address 82283 0
School of Optometry and Vision Science
UNSW Sydney
Gate 14, Barker St
Rupert Myers Building (North Wing)
Kensington, NSW, 2033
Country 82283 0
Australia
Phone 82283 0
+61 2 9385 9228
Fax 82283 0
Email 82283 0
[email protected]
Contact person for scientific queries
Name 82284 0
Dr Alex Hui
Address 82284 0
School of Optometry and Vision Science
UNSW Sydney
Gate 14, Barker St
Rupert Myers building (North Wing)
Kensington, NSW, 2033
Country 82284 0
Australia
Phone 82284 0
+61 2 9385 9228
Fax 82284 0
Email 82284 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


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.