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Trial registered on ANZCTR


Registration number
ACTRN12619001325190p
Ethics application status
Submitted, not yet approved
Date submitted
5/09/2019
Date registered
27/09/2019
Date last updated
27/09/2019
Date data sharing statement initially provided
27/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Topical Miotic Administered by the AcuStream Delivery System in Subjects with Presbyopia
Scientific title
A Double-Masked, Randomised Study of a Topical Miotic Administered by the AcuStream Delivery System on Near Visual Acuity in Subjects with Age-Related Presbyopia
Secondary ID [1] 299139 0
KT-101-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Presbyopia 314205 0
Condition category
Condition code
Eye 312564 312564 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dose: KT-101 will be self-administered by patients as a single, topical microdose (10ul) in 3 concentrations (1%, 2% and 4%) along with a placebo controlled arm. Adherence will be monitored through physician observation and record in clinic.

Duration: Each patient will receive a single dose of randomized treatment in each eye for one day.

Mode: Single stream, topical ophthalmic microdose (10ul) using AcuStream delivery system.
Intervention code [1] 315413 0
Treatment: Drugs
Intervention code [2] 315564 0
Treatment: Devices
Comparator / control treatment
Study is placebo controlled, using commercially available, over-the-counter, eye wash solution dispensed as a single stream in the AcuStream system.
Control group
Placebo

Outcomes
Primary outcome [1] 321214 0
Change from baseline distance corrected, near visual acuity using the CTS-1000 Smart System visual acuity measurement digital platform
Timepoint [1] 321214 0
1 Hour (primary time point), 2 Hour, and 4 Hour post intervention administration
Secondary outcome [1] 374332 0
Change from baseline pupil diameter as measured by the Neuroptics VIP-300 pupillometer or Neuroptics PLR-3000 pupillometer
Timepoint [1] 374332 0
1 Hour, 2 Hour, and 4 Hour post intervention administration
Secondary outcome [2] 374836 0
Change from baseline intraocular pressure as a marker for drug availability as measured by Goldmann applanation tonometry.
Timepoint [2] 374836 0
1 Hour, 2 Hours, and 4 Hours post intervention administration
Secondary outcome [3] 374837 0
Nature and incidence of potential adverse events (composite outcome) for AcuStream (pain, tolerability, photophobia, persistent miosis, posterior vitreous detachment, retinal breaks or detachment and ocular inflammation) as discovered by patient reported incidents, physician interview and examination
Timepoint [3] 374837 0
Baseline, 1 Hour, 2 Hour, and 4 Hour post intervention administration and follow up (one examination between days 2-12)

Eligibility
Key inclusion criteria
1) Diagnosis of symptomatic age-related presbyopia
2) Best distance corrected near visual acuity between 20/50 and 20/200
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Myopic manifest refractive error greater than -1.5-diopter in either eye
2) History of clinically significant or progressive retinal or ocular surface disease (including severe dry eye) in either eye
3) Clinically significant anisometropia, a difference in refractive power of two diopters or more between the two eyes
4) Unable to obtain best corrected photopic distance visual acuity of 20/25 or better in either eye
5) Maximal accommodative amplitude equal to 1.25-diopters in either eye
6) Prior cataract extraction with implantation of a multifocal IOL in either eye
7) Presence of untreated retinal tear, lattice degeneration or high-risk retinal lesion (in the
investigator’s opinion) in either eye
8) Clinically significant corneal dystrophy, epithelial or endothelial disease, corneal irregularities or scarring
9) Concurrent use of any topical ophthalmic medication(s) including artificial tears during trial participation
10) Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2019
Actual
Date of last participant enrolment
Anticipated
15/01/2020
Actual
Date of last data collection
Anticipated
31/01/2020
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 303678 0
Commercial sector/Industry
Name [1] 303678 0
Kedalion Therapeutics Australia Pty Ltd
Country [1] 303678 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Kedalion Therapeutics Australia Pty Ltd
Address
58 Gipps Street
Collingwood VIC 3066
Australia
Country
Australia
Secondary sponsor category [1] 303784 0
None
Name [1] 303784 0
Address [1] 303784 0
Country [1] 303784 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304200 0
Belberry
Ethics committee address [1] 304200 0
123 Glen Osmond Road Eastwood Adelaide
South Australia 5063
Ethics committee country [1] 304200 0
Australia
Date submitted for ethics approval [1] 304200 0
16/08/2019
Approval date [1] 304200 0
Ethics approval number [1] 304200 0

Summary
Brief summary
KT-101-02 is a multi-centre, randomised, double-masked, exploratory study of topical ocular miotic agents when administered as a microdose with the Kedalion AcuStream™ delivery system to improve symptoms of presbyopia. Pre-clinical testing evaluation and previous clinical trials show that miotics delivered through the AcuStream™ device have shown efficacy and safety for the treatment of presbyopia. This study will further define the efficacy benefits as well as tolerability and side effects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96130 0
Dr Laura Downie
Address 96130 0
University of Melbourne
Melbourne School of Health Sciences
161 Barry Street
Carlton, Victoria 3053
Country 96130 0
Australia
Phone 96130 0
+610390353043
Fax 96130 0
Email 96130 0
[email protected]
Contact person for public queries
Name 96131 0
Dr Mark Blumenkranz
Address 96131 0
Kedalion Therapeutics Australia, Pty, Ltd.
58 Gipps Street
Collingwood, Victoria 3066
Country 96131 0
Australia
Phone 96131 0
+610394097607
Fax 96131 0
Email 96131 0
[email protected]
Contact person for scientific queries
Name 96132 0
Dr Mark Blumenkranz
Address 96132 0
Kedalion Therapeutics Australia, Pty, Ltd.
58 Gipps Street
Collingwood, Victoria 3066
Country 96132 0
Australia
Phone 96132 0
+610394097607
Fax 96132 0
Email 96132 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.