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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04060758




Registration number
NCT04060758
Ethics application status
Date submitted
5/08/2019
Date registered
19/08/2019
Date last updated
30/04/2021

Titles & IDs
Public title
Open Label, Sequential-dose Study of PA5108 Latanoprost FA SR Ocular Implant for Mild-moderate Glaucoma
Scientific title
An Open Label, Comparative, Sequential-dose, Multi-centre Study Involving Intracameral Administration of a PA5108 Latanoprost FA SR Ocular Implant Into the Eye of Patients With Mild-moderate Glaucoma
Secondary ID [1] 0 0
LATA CS102
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 Latanoprost FA SR Ocular Implant

Experimental: 14.7 mcg - PA5108 Latanoprost FA SR Ocular Implant which releases 14.7 mcg.

Experimental: 26.6 mcg - PA5108 Latanoprost FA SR Ocular Implant which releases 26.6 mcg.

Experimental: 35.5 mcg - PA5108 Latanoprost FA SR Ocular Implant which releases 35.5 mcg.


Treatment: Drugs: PA5108 Latanoprost FA SR Ocular Implant
Ocular Implant

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Effective dose - Determine the minimum effective dose (as daily release rate of LtpFA) that achieves an IOP lowering effect >20% with minimal adverse events.
Timepoint [1] 0 0
Intraocular Pressure (IOP) change measured at; baseline, week 12 and week 26.
Primary outcome [2] 0 0
Safety and Tolerability-incidence of treatment emergent Adverse Events - Assess the safety and tolerability of PA5108 Latanoprost FA SR Ocular Implant in adults with Open Angle Glaucoma (Primary). Incidence of Treatment-Emergent Adverse Events from visit 1 until end of study. Safety laboratory evaluations (biochemistry, haematology, urinalysis). Physical examinations and vital signs. Changes in ocular examinations from baseline to end of study.
Timepoint [2] 0 0
Incidence of Treatment-Emergent Adverse Events throughout the study (up to 1 year).
Secondary outcome [1] 0 0
Ease of Use - Assess the ease of use of the bespoke administration device- Administering ophthalmologist's assessment of ease of use of the bespoke administration device, verbal communication.
Timepoint [1] 0 0
At visit 2-Day 0, after use of device to insert the implant into the eye.

Eligibility
Key inclusion criteria
Participants who:

- Diagnosis of primary open angle glaucoma.

- Unmedicated 8:00am IOP = 24 mmHg and = 36mmHg in the intent to treat eye.
Additionally, the IOP at 12:00 and 16:00 hrs must be = 20mmHg and = 36mmHg.

- Corrected visual acuity in each eye greater than or equal to +0.3logMAR.

- Minimum central endothelial cell density of greater than or equal to 1600 cells per
mm2

- Currently managing their POAG with IOP lowering drop therapy.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who:

- Have pseudoexfoliation or pigment dispersion component, history of angle closure, or
narrow angles.

- Have a history of or current ocular inflammation.

- Have aphakic eyes or only one eye.

- Recent surgery in the study eye surgery (including laser).

- Clinically significant ocular disease in either eye (e.g., corneal oedema, uveitis,
severe keratoconjunctivitis sicca or infection) which might interfere with the study.

- Known sensitivity to any component of the product (e.g. latanoprost or polytriazole
sensitivity), or to topical therapy used during course of study (e.g. povidone iodine,
or anaesthetics).

- Ocular medication in either eye of any kind within 30 days of screening.

- Central corneal thickness in either eye that is less than 470 µm or greater than 630
µm at screening (or a difference between the eyes >70 µm).

- Any abnormality in either eye preventing reliable applanation tonometry, including
aphakic eyes or significant corneal guttatae.

- Any other clinically significant disease (as determined by physician) which might
interfere with the study.

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



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

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
PersonalEYES - Castle Hill
Recruitment hospital [2] 0 0
Macquarie Hospital - Macquarie Park
Recruitment hospital [3] 0 0
Eye Associates - Sydney
Recruitment hospital [4] 0 0
Goodwood Eye Centre - Millswood
Recruitment hospital [5] 0 0
Bendigo Eye Clinic - Bendigo
Recruitment hospital [6] 0 0
Centre for Eye Research Australia - East Melbourne
Recruitment hospital [7] 0 0
Essendon Eye Clinic - Essendon
Recruitment hospital [8] 0 0
Melbourne Eye Specialists - Fitzroy
Recruitment hospital [9] 0 0
Eyes First - Springvale
Recruitment postcode(s) [1] 0 0
2150 - Castle Hill
Recruitment postcode(s) [2] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [3] 0 0
2000 - Sydney
Recruitment postcode(s) [4] 0 0
5034 - Millswood
Recruitment postcode(s) [5] 0 0
3550 - Bendigo
Recruitment postcode(s) [6] 0 0
3002 - East Melbourne
Recruitment postcode(s) [7] 0 0
3040 - Essendon
Recruitment postcode(s) [8] 0 0
3065 - Fitzroy
Recruitment postcode(s) [9] 0 0
3171 - Springvale

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a multi-centre, open label, interventional, comparative, phase I study to identify a
safe and efficacious dose (within the range of 14.7mcg to 35.5 mcg) of PA5108 (PolyActiva
product code) Latanoprost free acid (FA) sustained release (SR) Ocular Implant in adults who
have Primary Open Angle Glaucoma.
Trial website
https://clinicaltrials.gov/show/NCT04060758
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Coote
Address 0 0
Melbourne Eye Specialists
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Russell Tait
Address 0 0
Country 0 0
Phone 0 0
+61396570700
Fax 0 0
Email 0 0
russell.tait@polyactiva.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04060758