Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000433909
Ethics application status
Approved
Date submitted
31/01/2020
Date registered
1/04/2020
Date last updated
21/06/2021
Date data sharing statement initially provided
1/04/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of effect of eye drops on healthy volunteers
Scientific title
Effect of eye drops on accommodative response and pupil size in healthy volunteers
Secondary ID [1] 300374 0
CRTC2019-07
Secondary ID [2] 300601 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 315995 0
Condition category
Condition code
Eye 314267 314267 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Topically applied eye drops evaluated in two arms. The products and concentrations of arm 1 and arm 2 are given in the private notes section.
Concentrations and type of eyes drops are given in the private notes section
Single drop will be instilled to one eye only
Single administration
Optometrist will instill the eye drops
Eye drops will be instilled four times over a period of four months
Drops will be instilled at the clinic in Brien Holden Vision Institute
Not applicable as the drops will be instilled by the optometrist at the clinic
There is a minimum of four nights washout between the eye drops
Intervention code [1] 316660 0
Treatment: Drugs
Comparator / control treatment
Cross-over trial. The eye drops are compared to placebo.

Placebo is comprised of Sterile water
Control group
Active

Outcomes
Primary outcome [1] 322664 0
Change in pupillary diameter assessed using Gazepoint tracker
Timepoint [1] 322664 0
40 minutes from drop instillation
Secondary outcome [1] 379230 0
Change in accommodative response assessed using RAF ruler
Timepoint [1] 379230 0
40 minutes from drop instillation

Eligibility
Key inclusion criteria
(i) Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
(ii) Be between 18 to 35 years old, male or female.
(iii) Willing to comply with instillation of eye drops and clinical trial visit schedule as directed by the Investigator.
(iv) Have ocular health findings considered to be “normal”.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(i) Any pre-existing ocular irritation, injury or condition (including infection or disease).
(ii)Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and autoimmune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.
(iii) Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial.
(iv) 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 during the trial and at least 24 hours before the clinical trial product is used.
(v) Eye surgery within 12 weeks immediately prior to enrolment for this trial.
(vi) Previous corneal refractive surgery.
(vii) Known allergy or intolerance to ingredients in any of the clinical trial products (atropine and caffeine).
(viii) Currently enrolled in another clinical trial.
(ix) Participation in a clinical trial within the previous 2 weeks for dispensing studies and 48 hours between in-house studies.
(x) Pregnancy and breastfeeding*.
The Investigator may, at his/her 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.
*Formal testing of pregnancy is not required. A participant’s verbal report is sufficient.

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)
Central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Crossover
Other design features
Prospective double masked cross-over clinical trial
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/03/2020
Date of last participant enrolment
Anticipated
15/12/2020
Actual
11/01/2021
Date of last data collection
Anticipated
16/01/2021
Actual
4/03/2021
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 304798 0
Charities/Societies/Foundations
Name [1] 304798 0
Brien Holden Vision Institute
Country [1] 304798 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Brien Holden Vision Institute
Address
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 305125 0
None
Name [1] 305125 0
Address [1] 305125 0
Country [1] 305125 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305213 0
Bellberry Limited
Ethics committee address [1] 305213 0
Ethics committee country [1] 305213 0
Australia
Date submitted for ethics approval [1] 305213 0
Approval date [1] 305213 0
21/11/2019
Ethics approval number [1] 305213 0

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

Contacts
Principal investigator
Name 99630 0
Prof Padmaja Sankaridurg
Address 99630 0
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country 99630 0
Australia
Phone 99630 0
+61 293857516
Fax 99630 0
Email 99630 0
p.sankaridurg@bhvi.org
Contact person for public queries
Name 99631 0
Padmaja Sankaridurg
Address 99631 0
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country 99631 0
Australia
Phone 99631 0
+61 293857516
Fax 99631 0
Email 99631 0
p.sankaridurg@bhvi.org
Contact person for scientific queries
Name 99632 0
Padmaja Sankaridurg
Address 99632 0
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country 99632 0
Australia
Phone 99632 0
+61 293857516
Fax 99632 0
Email 99632 0
p.sankaridurg@bhvi.org

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.