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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05333419




Registration number
NCT05333419
Ethics application status
Date submitted
9/03/2022
Date registered
19/04/2022

Titles & IDs
Public title
Study of a Latanoprost Ocular Implant for Treatment of Open Angle Glaucoma or Ocular Hypertension.
Scientific title
Open Label Study to Evaluate the Safety, Tolerability and Biodegradation Period of PA5346 Latanoprost Free Acid (FA) Sustained Release (SR) Ocular Implant When Administered to Patients With Open Angle Glaucoma or Ocular Hypertension
Secondary ID [1] 0 0
LATA-CS103
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Open Angle Glaucoma 0 0
Ocular Hypertension 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 100ng/day PA5346 Latanoprost FA SR Ocular Implant

Experimental: Single Dose 100ng/day PA5346 Latanoprost FA SR Ocular Implant - After washout, eligible subjects will be dosed with a single 100ng/day PA5346 Latanoprost FA SR Ocular Implant at study Day 0.


Treatment: Drugs: 100ng/day PA5346 Latanoprost FA SR Ocular Implant
PA5346 ocular implant is a small, clear rod-shaped implant that is placed in the anterior (front) chamber of the eye, at a single timepoint, and slowly releases a drug called latanoprost free acid (100ng/day) over a period of approximately 30 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess the safety and tolerability of 100 ng/day PA5346 Latanoprost FA SR Ocular Implant in adults with Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT).
Timepoint [1] 0 0
Change from baseline to 40 weeks
Primary outcome [2] 0 0
To assess the safety and tolerability of 100 ng/day PA5346 Latanoprost FA SR Ocular Implant in adults with Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT).
Timepoint [2] 0 0
Change from baseline to 40 weeks
Primary outcome [3] 0 0
To assess the safety and tolerability of 100 ng/day PA5346 Latanoprost FA SR Ocular Implant in adults with Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT).
Timepoint [3] 0 0
Change from baseline to 40 weeks
Primary outcome [4] 0 0
To assess the safety and tolerability of 100 ng/day PA5346 Latanoprost FA SR Ocular Implant in adults with Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT).
Timepoint [4] 0 0
Change from baseline to 40 weeks
Primary outcome [5] 0 0
To assess the safety and tolerability of 100 ng/day PA5346 Latanoprost FA SR Ocular Implant in adults with Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT).
Timepoint [5] 0 0
Change from baseline to 40 weekls
Primary outcome [6] 0 0
To assess the period of biodegradation of 100 ng/day PA5346 Latanoprost FA SR Ocular Implant in adults with OAG or OHT.
Timepoint [6] 0 0
Up to 12 months
Secondary outcome [1] 0 0
To assess the initial efficacy of 100 ng/day PA5346 Latanoprost FA SR Ocular Implant in controlling IOP during a study period in adults with OAG or OHT.
Timepoint [1] 0 0
Up to 12 months
Secondary outcome [2] 0 0
Extent of hyperaemia.
Timepoint [2] 0 0
Up to 12 months
Secondary outcome [3] 0 0
Ophthalmologist-reported ease of use of bespoke administration device
Timepoint [3] 0 0
Day 0

Eligibility
Key inclusion criteria
* Have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
* Diagnosis of OAG or OHT. Iridocorneal angle must be classified as Grade 3 or 4 on the modified Shaffer-Etienne scale by gonioscopy.
* Unmedicated (post-washout) 8:00 AM IOP of 24 mmHg to 36 mmHg in the ITT eye at either of two qualification visits 2 weeks apart. In addition, the IOP at 12:00 noon and 4:00 PM must be 20 mmHg to 36 mmHg on the same qualification visit where the 8:00 AM IOP was IOP 24 mmHg to 36 mmHg.
* Have a corrected visual acuity as determined by Early Treatment of Diabetic Retinopathy Study (ETDRS) charts in each eye greater than or equal to + 0.3 logMAR (equivalent to 6/12).
* Minimum central endothelial cell density of greater than or equal to 1600 cells/mm2 as determined by the reading centre adopted for the study.
* Currently managing their OAG or OHT with IOP lowering drop therapy, including a prostaglandin analogue.
* Are able and willing to follow study instructions and adhere to the protocol schedule and restrictions and undergo eye examinations
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have pseudoexfoliation or pigment dispersion glaucoma
* Have aphakic eyes or only one functioning eye. only one eye.
* Have had iIntraocular surgery, glaucoma surgery or cornea/refractive surgery within the past 6 months or anticipate a need for eye surgery (including laser) in the study eye during the study period. .
* Significant corneal guttatae
* Ocular trauma in either eye within the three months prior to screening
* Current retinal detachment or history of blunt trauma in the study eye.
* Clinically significant ocular disease in either eye (e.g., corneal oedema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study Ocular trauma
* Have a known sensitivity to any component of the product (e.g. latanoprost, or polytriazole sensitivity), or to topical therapy used during the course of the study. Ocular infection or inflammation
* Have a clinical diagnosis of Fuchs' Endothelial Corneal Dystrophy (FECD) in the study eye or have confluent central corneal guttatae, multiple central guttatae greater than a single cell, or corneal disease or abnormality that would prevent specular microscopy corneal scans of the study eye.
* 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
4/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2023
Sample size
Target
Accrual to date
Final
1
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Wellington
Country [2] 0 0
New Zealand
State/province [2] 0 0
Rotorua

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
Tony Wells, MD
Address 0 0
Capital Eye Specialists
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/NCT05333419