Glaucoma, Open-AnglePhase 2NCT06964191
Evaluate Efficacy and Safety of PA5108 Ocular Implants in Primary Open Angle Glaucoma or Ocular Hypertension
A Phase 2 study testing PA5108 Ocular Implant low dose, PA5108 Ocular Implant, high dose and Latanoprost 0.005% Ophthalmic Solution in people with Glaucoma, Open-Angle and Ocular Hypertension, run by PolyActiva Pty Ltd at 1 site in United States.
Trial summary
The goal of this clinical trial is to determine the dose of PA5108 Ocular Implant that is effective and safe for the reduction of intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension, compared to the standard treatment therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Open-Angle, Ocular Hypertension
- What is being tested?
- PA5108 Ocular Implant low dose, PA5108 Ocular Implant, high dose and Latanoprost 0.005% Ophthalmic Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2025to 15 Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Ability to provide informed consent and follow study instructions
- 18 years of age or older
- Diagnosis of open-angle glaucoma or ocular hypertension in both eyes
- Qualifying IOPs across 2 visits following washout of IOP-lowering medication, if applicable
- Qualifying best-corrected visual acuity BCVA using Early Treatment Diabetic Retinopathy Study (ETDRS) chart in study eye
- Qualifying corneal endothelial cell density (CEDC) in the study eye
Who cannot join
- Pseudoexfoliation or pigment dispersion, narrow irido-corneal drainage angles, or existing peripheral anterior synechiae in the inferior angle either eye.
- Advanced or severe glaucoma
- Disqualifying central corneal thickness in either eye
- Significant other ocular conditions that could prevent accurate assessment of IOP and corneal health
- Uncontrolled medical conditions
- Have previously received, any injectable glaucoma medication into the anterior chamber of the study eye
- Have received intravitreal injections in the study eye within the last 3 months of the Screening Visit and anticipated need for an intravitreal injection during the course of the study
- Unwilling or unable to discontinue, in either eye, soft contact lens wear at least 2 days and hard contact lens wear 1 week before scheduled study visits and on implant administration days
Trial locations and contacts
1 site in 1 country.
United States1 site
Eye Research Foundation
Newport Beach, California, 92663
About this study
Official title: A Phase 2 Randomized, Multi-center, Parallel, Active-controlled Clinical Study to Evaluate the Safety and Efficacy of Intracameral PA5108 Ocular Implants in Patients With Primary Open-angle Glaucoma, or Ocular Hypertension
The goal of this clinical trial is to determine the dose of PA5108 Ocular Implant that is effective and safe for the reduction of intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension, compared to the standard treatment therapy.
Read the detailed description
This is a randomised, parallel, masked, active-controlled study that will evaluate the efficacy and safety of a low dose and a high dose of PA5108 Ocular Implant with single redosing during the study, in adults with open-angle glaucoma or ocular hypertension.
The study will also collect information on the implant administration procedure and overall experience from study participants.
The study plans to recruit approximately 75 participants.
Eligible participants will be randomly selected to receive one of the following treatments:
- PA5108 Ocular Implant - low dose in the study eye, and Latanoprost 0.005% eye drops in the other eye
- PA5108 Ocular Implant - high dose in the study eye, and Latanoprost 0.005% eye drops in the other eye
- Latanoprost 0.005% eye drops in both eyes (control treatment group) If allocated to receive either of the ocular implants, a second implant of the same dose will be administered at 26 weeks and participants will be followed for safety and intraocular pressure control until week 58 or until the implant is no longer visible in the study eye.
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Being tested
- PA5108 Ocular Implant low dose, PA5108 Ocular Implant, high dose, Latanoprost 0.005% Ophthalmic Solution
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PA5108 Ocular Implant low doseCombination product
The PA5108 Ocular Implant low dose is supplied preloaded into the needle of a single use administration device ready for use.
PA5108 Ocular Implant, high doseCombination product
The PA5108 Ocular Implant high dose is supplied preloaded into the needle of a single use administration device ready for use.
Latanoprost 0.005% Ophthalmic SolutionDrug
Latanoprost eye drops at a concentration of 0.005%
| Study group | Role | What they receive |
|---|---|---|
| PA5108 Ocular Implant low dose | Experimental | PA5108 Ocular Implant, low dose in the study eye, and latanoprost ophthalmic solution 0.005% once daily pm in the other eye. Receives: Combination Product: PA5108 Ocular Implant low dose; Drug: Latanoprost 0.005% Ophthalmic Solution |
| PA5108 Ocular Implant high dose | Experimental | PA5108 Ocular Implant, high dose in the study eye, and latanoprost ophthalmic solution 0.005% once daily pm in the other eye. Receives: Combination Product: PA5108 Ocular Implant, high dose; Drug: Latanoprost 0.005% Ophthalmic Solution |
| Latanoprost ophthalmic solution 0.005% | Active comparator | Latanoprost ophthalmic solution 0.005% once daily pm in both eyes. Receives: Drug: Latanoprost 0.005% Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: change in mean diurnal intraocular pressure in study eye
Measured: From Baseline to 12 weeks
Incidence of ocular symptoms and ocular treatment-emergent adverse events.
Ocular safety and tolerability (AEs)
Measured: Day 1 to study completion until at least Week 58
Clinically significant change on slit-lamp exam
Slit-lamp biomicroscopy of eye to observe clinically significant changes.
Measured: Day 1 to study completion until at least Week 58
Clinically significant change in corneal endothelial cells
Corneal endothelial cell density (cells/mm2) measured by specular microscopy.
Measured: Day 1 to study completion until at least Week 58
Secondary outcomes (1)
Efficacy: intraocular pressure change from baseline in study eye at different diurnal time points.
Measured: Weeks 2-52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start31 May 2025
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PolyActiva Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IUVO S.r.l.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964191
- Sponsor's protocol ID
- LATA-CS201
- Status last verified
- Jul 2026
- First submitted
- 25 Mar 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Multi-center, Parallel, Active-controlled Clinical Study to Evaluate the Safety and Efficacy of Intracameral PA5108 Ocular Implants in Patients With Primary Open-angle Glaucoma, or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT06964191
- Acronym / sponsor ID
- LATA-CS201
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- PolyActiva Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- IUVO S.r.l.
- Study start
- 31 May 2025 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 9 May 2025 (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.
The goal of this clinical trial is to determine the dose of PA5108 Ocular Implant that is effective and safe for the reduction of intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension, compared to the standard treatment therapy.
Detailed description
This is a randomised, parallel, masked, active-controlled study that will evaluate the efficacy and safety of a low dose and a high dose of PA5108 Ocular Implant with single redosing during the study, in adults with open-angle glaucoma or ocular hypertension.
The study will also collect information on the implant administration procedure and overall experience from study participants.
The study plans to recruit approximately 75 participants.
Eligible participants will be randomly selected to receive one of the following treatments:
- PA5108 Ocular Implant - low dose in the study eye, and Latanoprost 0.005% eye drops in the other eye
- PA5108 Ocular Implant - high dose in the study eye, and Latanoprost 0.005% eye drops in the other eye
- Latanoprost 0.005% eye drops in both eyes (control treatment group) If allocated to receive either of the ocular implants, a second implant of the same dose will be administered at 26 weeks and participants will be followed for safety and intraocular pressure control until week 58 or until the implant is no longer visible in the study eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PA5108 Ocular Implant low dose | Experimental | Combination Product: PA5108 Ocular Implant low dose, Drug: Latanoprost 0.005% Ophthalmic SolutionPA5108 Ocular Implant, low dose in the study eye, and latanoprost ophthalmic solution 0.005% once daily pm in the other eye. |
| PA5108 Ocular Implant high dose | Experimental | Combination Product: PA5108 Ocular Implant, high dose, Drug: Latanoprost 0.005% Ophthalmic SolutionPA5108 Ocular Implant, high dose in the study eye, and latanoprost ophthalmic solution 0.005% once daily pm in the other eye. |
| Latanoprost ophthalmic solution 0.005% | Active comparator | Drug: Latanoprost 0.005% Ophthalmic SolutionLatanoprost ophthalmic solution 0.005% once daily pm in both eyes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ability to provide informed consent and follow study instructions
- 18 years of age or older
- Diagnosis of open-angle glaucoma or ocular hypertension in both eyes
- Qualifying IOPs across 2 visits following washout of IOP-lowering medication, if applicable
- Qualifying best-corrected visual acuity BCVA using Early Treatment Diabetic Retinopathy Study (ETDRS) chart in study eye
Key exclusion criteria (8 listed)
- Pseudoexfoliation or pigment dispersion, narrow irido-corneal drainage angles, or existing peripheral anterior synechiae in the inferior angle either eye.
- Advanced or severe glaucoma
- Disqualifying central corneal thickness in either eye
- Significant other ocular conditions that could prevent accurate assessment of IOP and corneal health
- Uncontrolled medical conditions
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 Ocular Implant low doseThe PA5108 Ocular Implant low dose is supplied preloaded into the needle of a single use administration device ready for use. | Combination product | PA5108 Ocular Implant low dose |
| PA5108 Ocular Implant, high doseThe PA5108 Ocular Implant high dose is supplied preloaded into the needle of a single use administration device ready for use. | Combination product | PA5108 Ocular Implant high dose |
| Latanoprost 0.005% Ophthalmic SolutionLatanoprost eye drops at a concentration of 0.005% | Drug | Latanoprost ophthalmic solution 0.005%, PA5108 Ocular Implant high dose, PA5108 Ocular Implant low dose |
Primary outcome
Efficacy: change in mean diurnal intraocular pressure in study eye
Time frame: From Baseline to 12 weeks
Incidence of ocular symptoms and ocular treatment-emergent adverse events.
Time frame: Day 1 to study completion until at least Week 58
Ocular safety and tolerability (AEs)
Clinically significant change on slit-lamp exam
Time frame: Day 1 to study completion until at least Week 58
Slit-lamp biomicroscopy of eye to observe clinically significant changes.
Clinically significant change in corneal endothelial cells
Time frame: Day 1 to study completion until at least Week 58
Corneal endothelial cell density (cells/mm2) measured by specular microscopy.
1 secondary outcome
Efficacy: intraocular pressure change from baseline in study eye at different diurnal time points.
Time frame: Weeks 2-52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PA5108 Ocular Implant low dose, PA5108 Ocular Implant, high dose and Latanoprost 0.005% Ophthalmic Solution in people with Glaucoma, Open-Angle and Ocular Hypertension, run by PolyActiva Pty Ltd at 1 site in United States.
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 8 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: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Efficacy: change in mean diurnal intraocular pressure in study eye (time frame: From Baseline to 12 weeks). The study lists 4 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 8 Jul 2026.