Open Angle GlaucomaPhase 1NCT04060758
Open Label, Sequential-dose Study of PA5108 Latanoprost FA SR Ocular Implant for Mild-moderate Glaucoma
A Phase 1 study testing PA5108 Latanoprost FA SR Ocular Implant in people with Open Angle Glaucoma, run by PolyActiva Pty Ltd at 9 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- PA5108 Latanoprost FA SR Ocular Implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 11 Mar 2020to 13 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Australia8 sites
Bendigo Eye Clinic
Bendigo, Victoria, 3550
PersonalEYES
Castle Hill, New South Wales, 2150
Centre for Eye Research Australia
East Melbourne, Victoria, 3002
Essendon Eye Clinic
Essendon, Victoria, 3040
Melbourne Eye Specialists
Fitzroy, Victoria, 3065
Goodwood Eye Centre
Millswood, South Australia, 5034
Eyes First
Springvale, Victoria, 3171
Eye Surgery Associates
Vermont South, Victoria, 3133
About this study
Official 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
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.
Read the detailed description
This is a multi-centre, open label, interventional, comparative, phase Ib dose ranging study to identify a safe and efficacious dose (within the range of 14.7 to 35.5 microgram) of PA5108 Latanoprost FA SR Ocular Implant in adults who have Primary Open Angle Glaucoma (POAG).
The proposed study is a single ascending dose design to determine the minimum effective dose that provides the target of >20% IOP lowering effect at 12 weeks with minimal adverse events.
Up to three single-dose cohorts will be assessed from the following implant strengths:
- 35.5 microgram
- 26.6 microgram
- 14.7 microgram
In addition, a repeat-dose cohort will be assessed from the following implant strength:
- 14.7 microgram
A first cohort of participants will be recruited and dosed with the 14.7 mcg PA5108 Latanoprost FA SR Ocular Implant. A second cohort of participants will be recruited after SMC review of 6-week data of the first cohort and dosed with the 26.6 mcg PA5108 Latanoprost FA SR Ocular Implant. A third cohort of participants will be recruited after SMC review of 6-week data of the second cohort and repeat-dosed with 14.7 mcg PA5108 Latanoprost FA SR Ocular Implant. A fourth cohort of participants will be recruited and dosed with the 35.5 mcg PA5108 Latanoprost FA SR Ocular Implant
Prior to study registration, participants will have been medicated with intraocular pressure (IOP) lowering drop therapy, including a prostaglandin analogue, to manage their POAG. The IOP lowering drops will be stopped in the intent to treat eye within 29 to 43 days prior to the date of implant administration. Participants will be required to have an unmedicated (post wash-out) 8:00am IOP ≥ 24 mmHg and ≤ 36mmHg in the intent to treat eye at either of two screening visits 2-weeks apart. Additionally, the IOP at 12:00 noon and 4:00 pm must be ≥ 20mmHg and ≤ 36mmHg on the same screening visit where the 8:00am IOP was ≥ 24 mmHg and ≤ 36mmHg.
The PA5108 Latanoprost FA SR Ocular Implant will be administered to one eye (unilateral) of each participant.
IOP will be monitored and if after implant administration is found to rise ≥30% over baseline in the study eye, IOP lowering eye drops will be restarted.
The study will recruit up to 10 participants per cohort/dose level. After screening, eligible participants enrolled in the single-dose cohorts will be administered a single PA5108 Latanoprost FA SR Ocular Implant by clear corneal injection to the anterior chamber of the eye, by means of a custom-built injector fitted with a 27G pre-loaded needle at Day 0. Whereas eligible participants enrolled in the repeat-dose cohort will be administered a single PA5108 Latanoprost FA SR Ocular Implant by clear corneal injection to the anterior chamber of the eye, by means of a custom-built injector fitted with a 27G pre-loaded needle at Day 0, and again at Week 21.
The study will end at the later of Visit 12 (48-weeks) for the last participant in the repeat dose cohort, or when the last of the study implants are no longer visible in the study eye and the IOP in the same eye has returned to a normal clinical care range, or 12-weeks has passed since the implant was no longer visible regardless of IOP.
Participants in the single dose cohorts will attend the study site for follow up on Day 1 post implant administration, and then Week 6, 12, (optionally 15), 18, (optionally 21), 26, 32 and if required subsequent 6-week intervals until the implant has completely biodegraded and the IOP of the same eye has returned to normal clinical care range or 12-weeks has passed since the implant was no longer visible. Implant biodegradation will be confirmed by biomicroscopy and gonioscopy examination at Week 6, 12, optionally 15, 18, optionally 21, 26 \& 32, and if necessary, every 6-weeks thereafter.
Participants in the repeat dose cohort will attend the study site for follow up on Day 1 post implant administration, and then Week 6, 12,18, Week 21 (when they will be administered the second dose), Day 1 post repeat dose, Week 27, 33, 42, 48 and if required subsequent 6-week intervals until the implant has completely biodegraded and the IOP of the same eye has returned to normal clinical care range or 12-weeks has passed since the implant was no longer visible. Implant biodegradation will be confirmed by biomicroscopy and gonioscopy examination at Week 6,12,18, 21,27, 33,42 \& 48, and if necessary, every 6-weeks thereafter.
- Conditions
- Open Angle Glaucoma
- Being tested
- PA5108 Latanoprost FA SR Ocular Implant
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PA5108 Latanoprost FA SR Ocular ImplantDrug
Also called PA5108
Ocular Implant
| Study group | Role | What they receive |
|---|---|---|
| 14.7 mcg (single dose) | Experimental | PA5108 Latanoprost FA SR Ocular Implant which releases 14.7 mcg. Receives: Drug: PA5108 Latanoprost FA SR Ocular Implant |
| 26.6 mcg (single dose) | Experimental | PA5108 Latanoprost FA SR Ocular Implant which releases 26.6 mcg. Receives: Drug: PA5108 Latanoprost FA SR Ocular Implant |
| 35.5 mcg (single dose) | Experimental | PA5108 Latanoprost FA SR Ocular Implant which releases 35.5 mcg. Receives: Drug: PA5108 Latanoprost FA SR Ocular Implant |
| 14.7 mcg (repeat dose) | Experimental | Repeat dose of PA5108 Latanoprost FA SR Ocular Implant which releases 14.7 mcg. Receives: Drug: PA5108 Latanoprost FA SR Ocular Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective dose
Determine the minimum effective dose (as daily release rate of LtpFA) that achieves an IOP lowering effect >20% with minimal adverse events.
Measured: Intraocular Pressure (IOP) change measured at; baseline, week 12 and week 26.
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.
Measured: Incidence of Treatment-Emergent Adverse Events throughout the study (up to 1 year).
Secondary outcomes (1)
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.
Measured: At visit 2-Day 0, after use of device to insert the implant into the eye.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start11 Mar 2020
- Primary completion13 May 2025
- Study completion13 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- PolyActiva Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Coote, Principal investigator, Melbourne Eye Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060758
- Sponsor's protocol ID
- LATA CS102
- Status last verified
- Nov 2025
- First submitted
- 5 Aug 2019
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04060758
- Acronym / sponsor ID
- LATA CS102
- Conditions
- Open Angle Glaucoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- PolyActiva Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 13 May 2025 (actual)
- Study completion
- 13 May 2025 (actual)
- First posted
- 19 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multi-centre, open label, interventional, comparative, phase Ib dose ranging study to identify a safe and efficacious dose (within the range of 14.7 to 35.5 microgram) of PA5108 Latanoprost FA SR Ocular Implant in adults who have Primary Open Angle Glaucoma (POAG).
The proposed study is a single ascending dose design to determine the minimum effective dose that provides the target of >20% IOP lowering effect at 12 weeks with minimal adverse events.
Up to three single-dose cohorts will be assessed from the following implant strengths:
- 35.5 microgram
- 26.6 microgram
- 14.7 microgram
In addition, a repeat-dose cohort will be assessed from the following implant strength:
- 14.7 microgram
A first cohort of participants will be recruited and dosed with the 14.7 mcg PA5108 Latanoprost FA SR Ocular Implant. A second cohort of participants will be recruited after SMC review of 6-week data of the first cohort and dosed with the 26.6 mcg PA5108 Latanoprost FA SR Ocular Implant. A third cohort of participants will be recruited after SMC review of 6-week data of the second cohort and repeat-dosed with 14.7 mcg PA5108 Latanoprost FA SR Ocular Implant. A fourth cohort of participants will be recruited and dosed with the 35.5 mcg PA5108 Latanoprost FA SR Ocular Implant
Prior to study registration, participants will have been medicated with intraocular pressure (IOP) lowering drop therapy, including a prostaglandin analogue, to manage their POAG. The IOP lowering drops will be stopped in the intent to treat eye within 29 to 43 days prior to the date of implant administration. Participants will be required to have an unmedicated (post wash-out) 8:00am IOP ≥ 24 mmHg and ≤ 36mmHg in the intent to treat eye at either of two screening visits 2-weeks apart. Additionally, the IOP at 12:00 noon and 4:00 pm must be ≥ 20mmHg and ≤ 36mmHg on the same screening visit where the 8:00am IOP was ≥ 24 mmHg and ≤ 36mmHg.
The PA5108 Latanoprost FA SR Ocular Implant will be administered to one eye (unilateral) of each participant.
IOP will be monitored and if after implant administration is found to rise ≥30% over baseline in the study eye, IOP lowering eye drops will be restarted.
The study will recruit up to 10 participants per cohort/dose level. After screening, eligible participants enrolled in the single-dose cohorts will be administered a single PA5108 Latanoprost FA SR Ocular Implant by clear corneal injection to the anterior chamber of the eye, by means of a custom-built injector fitted with a 27G pre-loaded needle at Day 0. Whereas eligible participants enrolled in the repeat-dose cohort will be administered a single PA5108 Latanoprost FA SR Ocular Implant by clear corneal injection to the anterior chamber of the eye, by means of a custom-built injector fitted with a 27G pre-loaded needle at Day 0, and again at Week 21.
The study will end at the later of Visit 12 (48-weeks) for the last participant in the repeat dose cohort, or when the last of the study implants are no longer visible in the study eye and the IOP in the same eye has returned to a normal clinical care range, or 12-weeks has passed since the implant was no longer visible regardless of IOP.
Participants in the single dose cohorts will attend the study site for follow up on Day 1 post implant administration, and then Week 6, 12, (optionally 15), 18, (optionally 21), 26, 32 and if required subsequent 6-week intervals until the implant has completely biodegraded and the IOP of the same eye has returned to normal clinical care range or 12-weeks has passed since the implant was no longer visible. Implant biodegradation will be confirmed by biomicroscopy and gonioscopy examination at Week 6, 12, optionally 15, 18, optionally 21, 26 \& 32, and if necessary, every 6-weeks thereafter.
Participants in the repeat dose cohort will attend the study site for follow up on Day 1 post implant administration, and then Week 6, 12,18, Week 21 (when they will be administered the second dose), Day 1 post repeat dose, Week 27, 33, 42, 48 and if required subsequent 6-week intervals until the implant has completely biodegraded and the IOP of the same eye has returned to normal clinical care range or 12-weeks has passed since the implant was no longer visible. Implant biodegradation will be confirmed by biomicroscopy and gonioscopy examination at Week 6,12,18, 21,27, 33,42 \& 48, and if necessary, every 6-weeks thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 14.7 mcg (single dose) | Experimental | Drug: PA5108 Latanoprost FA SR Ocular ImplantPA5108 Latanoprost FA SR Ocular Implant which releases 14.7 mcg. |
| 26.6 mcg (single dose) | Experimental | Drug: PA5108 Latanoprost FA SR Ocular ImplantPA5108 Latanoprost FA SR Ocular Implant which releases 26.6 mcg. |
| 35.5 mcg (single dose) | Experimental | Drug: PA5108 Latanoprost FA SR Ocular ImplantPA5108 Latanoprost FA SR Ocular Implant which releases 35.5 mcg. |
| 14.7 mcg (repeat dose) | Experimental | Drug: PA5108 Latanoprost FA SR Ocular ImplantRepeat dose of PA5108 Latanoprost FA SR Ocular Implant which releases 14.7 mcg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PA5108 Latanoprost FA SR Ocular ImplantAlso: PA5108Ocular Implant | Drug | 14.7 mcg (repeat dose), 14.7 mcg (single dose), 26.6 mcg (single dose), 35.5 mcg (single dose) |
Primary outcome
Effective dose
Time frame: Intraocular Pressure (IOP) change measured at; baseline, week 12 and week 26.
Determine the minimum effective dose (as daily release rate of LtpFA) that achieves an IOP lowering effect >20% with minimal adverse events.
Safety and Tolerability-incidence of treatment emergent Adverse Events
Time frame: Incidence of Treatment-Emergent Adverse Events throughout the study (up to 1 year).
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.
1 secondary outcome
Ease of Use
Time frame: At visit 2-Day 0, after use of device to insert the implant into the eye.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Coote principal investigator
Melbourne Eye Specialists
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PA5108 Latanoprost FA SR Ocular Implant in people with Open Angle Glaucoma, run by PolyActiva Pty Ltd at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective dose (time frame: Intraocular Pressure (IOP) change measured at; baseline, week 12 and week 26.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.