Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000571370
Ethics application status
Approved
Date submitted
20/04/2017
Date registered
24/04/2017
Date last updated
11/02/2021
Date data sharing statement initially provided
29/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of preserved and unpreserved low dose topical atropine eye drops on the ocular surface
Scientific title
Effects of low dose topical 0.01% atropine eye drops with and without benzalkonium chloride (BAK) preservative on the ocular surface in healthy adults
Secondary ID [1] 291723 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ocular Surface Disease 302911 0
Myopia 302912 0
Dry Eye 302913 0
Condition category
Condition code
Eye 302396 302396 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Drug Name: Atropine Sulphate
Dose: 1 drop of 0.01% (unpreserved) atropine sulphate eye drops once daily (at night) in each eye
Duration: Four weeks
Mode of administration: Topical eye drop
Adherence Monitoring: Participants will be required to keep a dosage log and to return unused eye drops to monitor adherence
Intervention code [1] 297811 0
Treatment: Drugs
Comparator / control treatment
Drug Name: Atropine Sulphate
Dose: 1 drop of 0.01% atropine sulphate eye drops (preserved with 0.1 mg/mL benzalkonium chloride) once daily (at night) in each eye
Duration: Four weeks
Mode of administration: Topical eye drop
Adherence Monitoring: Participants will be required to keep a dosage log and to return unused eye drops to monitor adherence
Control group
Active

Outcomes
Primary outcome [1] 301807 0
Change in non-invasive tear breakup time (NITBUT) measured by Oculus Keratograph 5M
Timepoint [1] 301807 0
At baseline, 1 hour after drop instillation, 3-5 hours after drop instillation, 8 days after treatment initiation and 28 days after treatment initiation
Secondary outcome [1] 333919 0
Change in Ocular Surface Disease Index (OSDI) Score using the OSDI questionnaire
Timepoint [1] 333919 0
At baseline, 1 hour after drop instillation, 3-5 hours after drop instillation, 8 days after treatment initiation and 28 days after treatment initiation
Secondary outcome [2] 333920 0
Change in pupil size as measured by a pupillometer
Timepoint [2] 333920 0
At baseline, 1 hour after drop instillation, 3-5 hours after drop instillation, 8 days after treatment initiation and 28 days after treatment initiation
Secondary outcome [3] 333921 0
Change in amplitude of accomodation as measured by the push up tests
Timepoint [3] 333921 0
At baseline, 1 hour after drop instillation, 3-5 hours after drop instillation, 8 days after treatment initiation and 28 days after treatment initiation
Secondary outcome [4] 333922 0
Change in ocular surface staining scores as measured compared to the Oxford grading scales
Timepoint [4] 333922 0
At baseline, 1 hour after drop instillation, 3-5 hours after drop instillation, 8 days after treatment initiation and 28 days after treatment initiation
Secondary outcome [5] 333923 0
Change in tear volume as measured by anterior segment optical coherence tomography
Timepoint [5] 333923 0
At baseline, 1 hour after drop instillation, 3-5 hours after drop instillation, 8 days after treatment initiation and 28 days after treatment initiation
Secondary outcome [6] 334020 0
Change in latency of pupillary constriction as measured by a pupillometer
Timepoint [6] 334020 0
At baseline, 1 hour after drop instillation, 3-5 hours after drop instillation, 8 days after treatment initiation and 28 days after treatment initiation
Secondary outcome [7] 334021 0
Change in pupillary constriction velocity as measured by a pupillometer
Timepoint [7] 334021 0
At baseline, 1 hour after drop instillation, 3-5 hours after drop instillation, 8 days after treatment initiation and 28 days after treatment initiation
Secondary outcome [8] 334022 0
Change in maximum pupillary constriction velocity as measured by a pupillometer
Timepoint [8] 334022 0
At baseline, 1 hour after drop instillation, 3-5 hours after drop instillation, 8 days after treatment initiation and 28 days after treatment initiation
Secondary outcome [9] 334023 0
Change in average pupillary dilation velocity as measured by a pupillometer
Timepoint [9] 334023 0
At baseline, 1 hour after drop instillation, 3-5 hours after drop instillation, 8 days after treatment initiation and 28 days after treatment initiation
Secondary outcome [10] 334024 0
Change in time to reach 75% recovery in pupil size as measured by a pupillometer
Timepoint [10] 334024 0
At baseline, 1 hour after drop instillation, 3-5 hours after drop instillation, 8 days after treatment initiation and 28 days after treatment initiation

Eligibility
Key inclusion criteria
1) Adults aged between 18-40
2) Informed consent received
3) Have normal eye and general health
4) No reported allergy to atropine or preservatives
5) Willingness to comply with scheduled visits and other study procedures
6) No history of narrow-angle glaucoma 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 prior to enrollment
2) Any ocular disease including inflammation or allergy
3) History of allergic reaction to any topical ophthalmic drugs
4) Contact lens wearer
5) Currently using topical ophthalmic drugs
6) Anyone who is taking any form of medication
7) Pregnant women, planning to become pregnant, or breast-feeding

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 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The normal tear break up time (TBUT) has been reported to have a mean value 14.7 and standard deviation of 4.7 seconds. To be able to detect a 1 standard deviation change in TBUT, a sample size of 7 in each group is necessary. Assuming approximately a 50% discontinuation rate, our study aims to recruit 20 participants.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/05/2017
Actual
3/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
17
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 15810 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 296223 0
University
Name [1] 296223 0
UNSW Sydney
Country [1] 296223 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
UNSW Sydney
Sydney, NSW, AUSTRALIA
2052
Country
Australia
Secondary sponsor category [1] 295135 0
None
Name [1] 295135 0
Address [1] 295135 0
Country [1] 295135 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297462 0
UNSW Sydney Human Research Ethics Committee
Ethics committee address [1] 297462 0
UNSW Sydney
Sydney, NSW, AUSTRALIA
2052
Ethics committee country [1] 297462 0
Australia
Date submitted for ethics approval [1] 297462 0
26/04/2017
Approval date [1] 297462 0
07/06/2017
Ethics approval number [1] 297462 0
HC17279

Summary
Brief summary
Preservatives in eye drops, such as benzalkonium chloride (BAK), are necessary to prevent microbial contamination, but have been known to affect the comfort and health of the eye's structures, especially if used for long periods of time. This study will investigate the impact of BAK in participants using preserved and unpreserved atropine eye drops on their ocular comfort and health, as well as on the action of the drug itself.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74114 0
Dr Alex Hui
Address 74114 0
School of Optometry and Vision Science
UNSW Sydney
Sydney, NSW, Australia
2052
Country 74114 0
Australia
Phone 74114 0
+61 2 9385 9228
Fax 74114 0
Email 74114 0
[email protected]
Contact person for public queries
Name 74115 0
Dr Alex Hui
Address 74115 0
School of Optometry and Vision Science
UNSW Sydney
Sydney, NSW, Australia
2052
Country 74115 0
Australia
Phone 74115 0
+61 2 9385 9228
Fax 74115 0
Email 74115 0
[email protected]
Contact person for scientific queries
Name 74116 0
Dr Alex Hui
Address 74116 0
School of Optometry and Vision Science
UNSW Sydney
Sydney, NSW, Australia
2052
Country 74116 0
Australia
Phone 74116 0
+61 2 9385 9228
Fax 74116 0
Email 74116 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
Was not in initial protocol/ethics application


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.