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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03604328




Registration number
NCT03604328
Ethics application status
Date submitted
10/07/2018
Date registered
27/07/2018

Titles & IDs
Public title
Safety and Tolerability of a Prostaglandin Ocular Implant for Treatment of Open Angle Glaucoma
Scientific title
An Open-label Phase I Study to Evaluate the Safety, Tolerability and Biodegradation Period of PolyActiva PA5108 Ocular Implant When Administered Intracamerally to the Anterior Chamber of the Eye
Secondary ID [1] 0 0
LATA-CS101
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PA5108

Experimental: PA5108 - PA5108 ocular implant (study eye) and topical prostaglandin analogue therapy (non-study eye)


Treatment: Drugs: PA5108
single ocular implant, administered on day 1
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability as measured by the occurrence of adverse events
Timepoint [1] 0 0
4 weeks
Secondary outcome [1] 0 0
Timeframe to complete implant biodegradation based on implant size and location
Timepoint [1] 0 0
6 months

Eligibility
Key inclusion criteria
* Grade 3 or 4 open angle glaucoma (Shaffer-Etienne scale)
* Visual acuity in non-study eye same or better than study eye
* Currently taking topical ocular hypotensive medication including a prostaglandin analogue
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Aphakic eyes
* Only one eye
* History of, or current uveitis, Cystoid Macular Edema (CME) or cornea edema
* Intraocular surgery or cornea/refractive surgery in study eye in past 6 months or anticipate need for eye surgery (including laser) in study eye during study period
* Current retinal detachment
* Uncontrolled infection in the eye

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/06/2020
Sample size
Target
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Centre for Eye Research Australia - East Melbourne
Recruitment hospital [2] 0 0
Melbourne Eye Specialists - Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment postcode(s) [2] 0 0
3000 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
PolyActiva Pty Ltd
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Nathan Kerr
Address 0 0
The Royal Victorian Eye & Ear Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03604328