Open Angle GlaucomaPhase 1NCT05333419
Study of a Latanoprost Ocular Implant for Treatment of Open Angle Glaucoma or Ocular Hypertension.
A Phase 1 study testing 100ng/day PA5346 Latanoprost FA SR Ocular Implant in people with Open Angle Glaucoma and Ocular Hypertension, run by PolyActiva Pty Ltd at 2 sites in New Zealand.
Trial summary
This is an open label, single dose (100 ng/day) study to assess the safety, tolerability and biodegradation of the PA5436 Latanoprost FA SR Ocular Implant in adults who have OAG or OHT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- 100ng/day PA5346 Latanoprost FA SR Ocular Implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesNew Zealand
- Study dates
- 4 Mar 2022to 30 Sep 2023
- 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
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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).
Trial locations and contacts
2 sites in 1 country.
New Zealand2 sites
Rotorua Eye Clinic
Rotorua, 3015
Capital Eye Specialists
Te Aro, Wellington Region, 6011
About this study
Official 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
This is an open label, single dose (100 ng/day) study to assess the safety, tolerability and biodegradation of the PA5436 Latanoprost FA SR Ocular Implant in adults who have OAG or OHT.
Read the detailed description
Participants who are currently administering Intraocular Pressure lowering drop therapy for Open Angle Glaucoma or Ocular Hypertension will be recruited.
Prior to recruitment, participants will be medicated with IOP lowering drop therapy, including a prostaglandin analogue to manage their POAG. The IOP lowering eye drops will be stopped in the intent to treat (ITT) eye at least 28 days and no greater than 49 days prior to the date of implant administration.
Participants will be required to have an unmedicated (post washout) 8:00 AM IOP ≥ 24 mmHg and ≤ 36 mmHg in the ITT eye at either of 2 screening visits 2 weeks apart.
Participants are also required to have an unmedicated (post washout) IOP ≥ 20 mmHg and ≤ 36 mmHg at 12:00 noon and 4:00 PM in the same eye on the same screening visit where the 8:00 AM IOP was IOP ≥ 24 mmHg and ≤ 36mmHg.
The PA5346 Latanoprost FA SR Ocular Implant will be administered to one eye (unilateral) of each participant.
IOP will be monitored and if during the course of the study it is found to rise ≥ 30% over baseline in the study eye(s), IOP lowering eye drops will be resumed.
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Being tested
- 100ng/day PA5346 Latanoprost FA SR Ocular Implant
- 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.
100ng/day PA5346 Latanoprost FA SR Ocular ImplantDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Single Dose 100ng/day PA5346 Latanoprost FA SR Ocular Implant | Experimental | After washout, eligible subjects will be dosed with a single 100ng/day PA5346 Latanoprost FA SR Ocular Implant at study Day 0. Receives: Drug: 100ng/day PA5346 Latanoprost FA SR Ocular Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Clinically significant changes to haematology or biochemistry
Measured: Change from baseline to 40 weeks
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).
Clinically significant changes to urinalysis
Measured: Change from baseline to 40 weeks
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).
Clinically significant changes to physical examination
Measured: Change from baseline to 40 weeks
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).
Clinically significant changes to vital signs
Measured: Change from baseline to 40 weeks
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).
Clinically significant changes to visual acuity
Measured: Change from baseline to 40 weekls
To assess the period of biodegradation of 100 ng/day PA5346 Latanoprost FA SR Ocular Implant in adults with OAG or OHT.
Biodegradation will be assessed by Gonioscopy or anterior Optical Coherence at Tomography (OCT) at Weeks 6, 12, 18, 26, 34, 40 and each subsequent 6 week visit thereafter until the implant has completely biodegraded. These tests allow the implant to be located by the ophthalmologist.
Measured: Up to 12 months
Secondary outcomes (3)
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.
IOP will be assess by using a tonometer at Day 1, Weeks 6, 18, 26, 34, 40 and every 6 weekly visit after intervention commencement.
Measured: Up to 12 months
Extent of hyperaemia.
Assessed by Slit lamp Biomicroscopy for Conjunctival Redness Day 1, Weeks 6, 18, 26, 34, 40 and every 6 weekly visit after intervention commencement.
Measured: Up to 12 months
Ophthalmologist-reported ease of use of bespoke administration device
This questionnaire is descriptive only and includes questions such as:
- Ease of attaching the implant-containing needle to the administration device
- Ease of inserting the implant in the correct location
- Number of times the plunger is depressed to extrude the implant.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start4 Mar 2022
- Primary completion12 Jun 2023
- Study completion30 Sep 2023
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- PolyActiva Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tony Wells, MD, Principal investigator, Capital Eye Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333419
- Sponsor's protocol ID
- LATA-CS103
- Status last verified
- Apr 2024
- First submitted
- 9 Mar 2022
- Last updated
- 12 Apr 2024
- 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 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05333419
- Acronym / sponsor ID
- LATA-CS103
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- PolyActiva Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2022 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 19 Apr 2022 (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 an open label, single dose (100 ng/day) study to assess the safety, tolerability and biodegradation of the PA5436 Latanoprost FA SR Ocular Implant in adults who have OAG or OHT.
Detailed description
Participants who are currently administering Intraocular Pressure lowering drop therapy for Open Angle Glaucoma or Ocular Hypertension will be recruited.
Prior to recruitment, participants will be medicated with IOP lowering drop therapy, including a prostaglandin analogue to manage their POAG. The IOP lowering eye drops will be stopped in the intent to treat (ITT) eye at least 28 days and no greater than 49 days prior to the date of implant administration.
Participants will be required to have an unmedicated (post washout) 8:00 AM IOP ≥ 24 mmHg and ≤ 36 mmHg in the ITT eye at either of 2 screening visits 2 weeks apart.
Participants are also required to have an unmedicated (post washout) IOP ≥ 20 mmHg and ≤ 36 mmHg at 12:00 noon and 4:00 PM in the same eye on the same screening visit where the 8:00 AM IOP was IOP ≥ 24 mmHg and ≤ 36mmHg.
The PA5346 Latanoprost FA SR Ocular Implant will be administered to one eye (unilateral) of each participant.
IOP will be monitored and if during the course of the study it is found to rise ≥ 30% over baseline in the study eye(s), IOP lowering eye drops will be resumed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Dose 100ng/day PA5346 Latanoprost FA SR Ocular Implant | Experimental | Drug: 100ng/day PA5346 Latanoprost FA SR Ocular ImplantAfter washout, eligible subjects will be dosed with a single 100ng/day PA5346 Latanoprost FA SR Ocular Implant at study Day 0. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| 100ng/day PA5346 Latanoprost FA SR Ocular ImplantPA5346 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 | Drug | Single Dose 100ng/day PA5346 Latanoprost FA SR Ocular Implant |
Primary outcome
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).
Time frame: Change from baseline to 40 weeks
Clinically significant changes to haematology or biochemistry
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).
Time frame: Change from baseline to 40 weeks
Clinically significant changes to urinalysis
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).
Time frame: Change from baseline to 40 weeks
Clinically significant changes to physical examination
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).
Time frame: Change from baseline to 40 weeks
Clinically significant changes to vital signs
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).
Time frame: Change from baseline to 40 weekls
Clinically significant changes to visual acuity
To assess the period of biodegradation of 100 ng/day PA5346 Latanoprost FA SR Ocular Implant in adults with OAG or OHT.
Time frame: Up to 12 months
Biodegradation will be assessed by Gonioscopy or anterior Optical Coherence at Tomography (OCT) at Weeks 6, 12, 18, 26, 34, 40 and each subsequent 6 week visit thereafter until the implant has completely biodegraded. These tests allow the implant to be located by the ophthalmologist.
3 secondary outcomes
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.
Time frame: Up to 12 months
Extent of hyperaemia.
Time frame: Up to 12 months
Ophthalmologist-reported ease of use of bespoke administration device
Time frame: Day 0
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 12 Apr 2024.
- 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.
Tony Wells, MD principal investigator
Capital Eye Specialists
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 100ng/day PA5346 Latanoprost FA SR Ocular Implant in people with Open Angle Glaucoma and Ocular Hypertension, run by PolyActiva Pty Ltd at 2 sites in New Zealand.
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 7 inclusion and 10 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 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in 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?
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). (time frame: Change from baseline to 40 weeks). The study lists 6 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 12 Apr 2024.