Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000033246
Ethics application status
Approved
Date submitted
8/12/2017
Date registered
12/01/2018
Date last updated
7/07/2020
Date data sharing statement initially provided
8/01/2019
Date results information initially provided
7/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A double-blind, placebo-controlled, randomised trial to determine the ocular pharmacokinetics and safety of oral FT011 in patients with glaucoma.
Scientific title
A double-blind, placebo-controlled, randomised trial to determine the ocular pharmacokinetics and safety of oral FT011 in patients with glaucoma.
Secondary ID [1] 292923 0
Sponsor protocol OCC-FT011-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma 304802 0
Condition category
Condition code
Eye 304100 304100 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1: FT011 50mg orally once daily for 28 days, commencing 7 days prior to surgery
Group 2: FT011 100mg orally once daily for 28 days, commencing 7 days prior to surgery
Intervention code [1] 299154 0
Treatment: Drugs
Comparator / control treatment
Placebo (microcellulose) once daily for 28 days, commencing 7 days prior to surgery
Control group
Placebo

Outcomes
Primary outcome [1] 303428 0
FT011 level in the aqueous humor (single sample time point)
Timepoint [1] 303428 0
Day of surgery (Day 7 of study drug administration)
Primary outcome [2] 304349 0
FT011 level in the tenon's capsule (single sample time point)
Timepoint [2] 304349 0
Day of surgery (Day 7 of study drug administration)
Secondary outcome [1] 338893 0
Ocular safety of FT011 assessed by eye examinations
Timepoint [1] 338893 0
Day 7, Week 4 and Week 12 post start of study drug

Eligibility
Key inclusion criteria
- Male or female, aged at least 18 years.
- Have confirmed glaucoma.
- Are scheduled to have trabeculectomy, tube surgery, or other glaucoma surgery, performed at the study site.
- Agree to practice effective contraception (as outlined in the protocol) during the study period.
- Provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- pregnant or breastfeeding, or plan to become pregnant during the study
- Have received any investigational drug within 5 half-lives or the 2 months prior to Screening (4 months if the previous drug was a new chemical entity), whichever is longer.
- Have only one eye
- Have active uveitis.
- Have clinically significant ocular conditions other than glaucoma.
- Have had ocular surgery in the 6 months prior to screening.
- Have a known allergy to the investigational medicinal product (IMP).
- Have any other medical condition or significant co-morbidities, or any finding during Screening, which may interfere with the study objectives in the investigator’s opinion.
Have a history of or current clinically relevant social, clinical, or psychiatric condition which, in the opinion of the investigator, makes the participant unsuitable for participation in the study.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/01/2019
Actual
13/05/2019
Date of last participant enrolment
Anticipated
Actual
17/10/2019
Date of last data collection
Anticipated
Actual
31/01/2020
Sample size
Target
8
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 297552 0
Commercial sector/Industry
Name [1] 297552 0
Occurx Pty Ltd
Country [1] 297552 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Occurx Pty Ltd
Address
Level 9/31 Queen St
Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 296562 0
None
Name [1] 296562 0
Address [1] 296562 0
Country [1] 296562 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298647 0
Royal Victorian Eye and Ear Hospital Human Research Ethics Committee
Ethics committee address [1] 298647 0
Locked Bag 8
East Melbourne VIC 8002
Ethics committee country [1] 298647 0
Australia
Date submitted for ethics approval [1] 298647 0
08/11/2017
Approval date [1] 298647 0
05/03/2018
Ethics approval number [1] 298647 0

Summary
Brief summary
FT011 is being investigated as a potential drug to inhibit scar formation in the eye after surgery. The main aim of this study is to assess whether FT011 can enter the eye, as well as determine the safety of FT011 in the eye.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77766 0
Dr Nathan Kerr
Address 77766 0
Royal Victorian Eye and Ear Hospital
32 Gisborne Street
East Melbourne, VIC, 3002
Country 77766 0
Australia
Phone 77766 0
+61 3 9929 8360
Fax 77766 0
Email 77766 0
[email protected]
Contact person for public queries
Name 77767 0
Prof Darren Kelly
Address 77767 0
Occurx Pty Ltd
Level 9/31 Queen St
Melbourne VIC 3000
Country 77767 0
Australia
Phone 77767 0
+61 3 9657 0704
Fax 77767 0
Email 77767 0
[email protected]
Contact person for scientific queries
Name 77768 0
Prof Darren Kelly
Address 77768 0
Occurx Pty Ltd
Level 9/31 Queen St
Melbourne VIC 3000
Country 77768 0
Australia
Phone 77768 0
+61 3 9657 0704
Fax 77768 0
Email 77768 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
This is a small PK study to guide further development plans. Individual participant results are not useful to the participants or to others outside of the sponsor.


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.