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Trial registered on ANZCTR


Registration number
ACTRN12621000233820
Ethics application status
Approved
Date submitted
4/02/2021
Date registered
5/03/2021
Date last updated
5/03/2021
Date data sharing statement initially provided
5/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects and recovery from daily and alternate-day instillation of various low-dose atropine eye drops
Scientific title
Effects on pupil size and recovery from daily and alternate-day instillation of various low-dose atropine eye drops in adults with healthy vision
Secondary ID [1] 303342 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 320595 0
Condition category
Condition code
Eye 318451 318451 0 0
Normal eye development and function
Eye 318452 318452 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: Daily instillation for 7 days (7 doses) in one eye, every other day instillation for 7 days (4 doses) in fellow eye
Mode of administration: Topical eye drop instilled directly by subject before bed
Adherence Monitoring: Participant compliance diary

Arm 2:
Drug Name: Atropine Sulphate
Dose: 1 drop of 0.05% atropine sulphate eye drops in each eye
Duration: Daily instillation for 7 days (7 doses) in one eye, every other day instillation for 7 days (4 doses) in fellow eye
Mode of administration: Topical eye drop instilled directly by subject before bed
Adherence Monitoring: Participant compliance diary
Intervention code [1] 319652 0
Treatment: Drugs
Comparator / control treatment
Arm 3:
Drug Name: None
Dose: 1 drop of vehicle (artificial tears) in each eye
Duration: Daily instillation for 7 days (7 doses) in one eye, every other day instillation for 7 days (4 doses) in fellow eye
Mode of administration: Topical eye drop instilled directly by subject before bed
Adherence Monitoring: Participant compliance diary
Control group
Placebo

Outcomes
Primary outcome [1] 326414 0
Change in initial pupil size as measured by a pupillometer
Timepoint [1] 326414 0
Baseline, 4 days after beginning drop instillation, 8 days after beginning drop instillation, 11 days after beginning drop instillation, (if necessary) 15 days after beginning drop instillation
Primary outcome [2] 326729 0
Change in minimum pupil size as measured by a pupillometer
Timepoint [2] 326729 0
Baseline, 4 days after beginning drop instillation, 8 days after beginning drop instillation, 11 days after beginning drop instillation, (if necessary) 15 days after beginning drop instillation
Secondary outcome [1] 391398 0
Change in amplitude of accomodation as measured by push up tests
Timepoint [1] 391398 0
Baseline, 4 days after beginning drop instillation, 8 days after beginning drop instillation, 11 days after beginning drop instillation, (if necessary) 15 days after beginning drop instillation
Secondary outcome [2] 391399 0
Change in quality of vision as measured by the Quality of Vision Questionnaire
Timepoint [2] 391399 0
Baseline, 4 days after beginning drop instillation, 8 days after beginning drop instillation, 11 days after beginning drop instillation, (if necessary) 15 days after beginning drop instillation
Secondary outcome [3] 391400 0
Change in axial length as measured by IOLMaster
Timepoint [3] 391400 0
Baseline, 4 days after beginning drop instillation, 8 days after beginning drop instillation, 11 days after beginning drop instillation, (if necessary) 15 days after beginning drop instillation
Secondary outcome [4] 391401 0
Change in refractive error using autorefraction and subjective refraction
Timepoint [4] 391401 0
Baseline, 4 days after beginning drop instillation, 8 days after beginning drop instillation, 11 days after beginning drop instillation, (if necessary) 15 days after beginning drop instillation
Secondary outcome [5] 391402 0
Compliance with drop regimen via diary
Timepoint [5] 391402 0
4 days after beginning drop instillation, 8 days after beginning drop instillation, 11 days after beginning drop instillation, (if necessary) 15 days after beginning drop instillation
Secondary outcome [6] 392495 0
Change in maximum pupil constriction velocity measured by a pupillometer
Timepoint [6] 392495 0
Baseline, 4 days after beginning drop instillation, 8 days after beginning drop instillation, 11 days after beginning drop instillation, (if necessary) 15 days after beginning drop instillation
Secondary outcome [7] 392496 0
Change in average pupil constriction velocity measured by a pupillometer
Timepoint [7] 392496 0
Baseline, 4 days after beginning drop instillation, 8 days after beginning drop instillation, 11 days after beginning drop instillation, (if necessary) 15 days after beginning drop instillation
Secondary outcome [8] 392497 0
Change in latency of pupil constriction measured by a pupillometer
Timepoint [8] 392497 0
Baseline, 4 days after beginning drop instillation, 8 days after beginning drop instillation, 11 days after beginning drop instillation, (if necessary) 15 days after beginning drop instillation
Secondary outcome [9] 392498 0
Change in average dilation velocity measured by a pupillometer
Timepoint [9] 392498 0
Baseline, 4 days after beginning drop instillation, 8 days after beginning drop instillation, 11 days after beginning drop instillation, (if necessary) 15 days after beginning drop instillation
Secondary outcome [10] 392499 0
Percentage change in pupil size measured by a pupillometer
Timepoint [10] 392499 0
Baseline, 4 days after beginning drop instillation, 8 days after beginning drop instillation, 11 days after beginning drop instillation, (if necessary) 15 days after beginning 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) Atropine eye drop use within 2 weeks 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\
7) History of cardiac disease

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/03/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 307759 0
University
Name [1] 307759 0
UNSW Sydney
Country [1] 307759 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] 308461 0
None
Name [1] 308461 0
Address [1] 308461 0
Country [1] 308461 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307780 0
UNSW Sydney Human Research Ethics Committee
Ethics committee address [1] 307780 0
Ethics committee country [1] 307780 0
Australia
Date submitted for ethics approval [1] 307780 0
23/11/2020
Approval date [1] 307780 0
19/02/2021
Ethics approval number [1] 307780 0
HC200969

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

Contacts
Principal investigator
Name 108474 0
Dr Alex Hui
Address 108474 0
School of Optometry and Vision Science
UNSW Sydney
Gate 14, Barker St
Rupert Myers building (North Wing)
Kensington, NSW, 2033
Country 108474 0
Australia
Phone 108474 0
+61293859228
Fax 108474 0
Email 108474 0
alex.hui@unsw.edu.au
Contact person for public queries
Name 108475 0
Alex Hui
Address 108475 0
School of Optometry and Vision Science
UNSW Sydney
Gate 14, Barker St
Rupert Myers building (North Wing)
Kensington, NSW, 2033
Country 108475 0
Australia
Phone 108475 0
+61293859228
Fax 108475 0
Email 108475 0
alex.hui@unsw.edu.au
Contact person for scientific queries
Name 108476 0
Alex Hui
Address 108476 0
School of Optometry and Vision Science
UNSW Sydney
Gate 14, Barker St
Rupert Myers building (North Wing)
Kensington, NSW, 2033
Country 108476 0
Australia
Phone 108476 0
+61293859228
Fax 108476 0
Email 108476 0
alex.hui@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
At this stage IPD is not planned on being made publicly available.


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.