Clinical trial NCT05333419: Study of a Latanoprost Ocular Implant for Treatment of Open Angle Glaucoma or Ocular Hypertension.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Open Angle Glaucoma
Ocular Hypertension
Lead sponsor: PolyActiva Pty Ltd
Sponsor class: INDUSTRY
First posted: 2022-04-19
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

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).

Primary outcomes:
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).
timeFrame: Change from baseline to 40 weeks
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).
timeFrame: Change from baseline to 40 weeks
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).
timeFrame: Change from baseline to 40 weeks
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).
timeFrame: Change from baseline to 40 weeks
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).
timeFrame: Change from baseline to 40 weekls
measure: To assess the period of biodegradation of 100 ng/day PA5346 Latanoprost FA SR Ocular Implant in adults with OAG or OHT.
timeFrame: Up to 12 months
Secondary outcomes:
measure: 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.
timeFrame: Up to 12 months
measure: Extent of hyperaemia.
timeFrame: Up to 12 months
measure: Ophthalmologist-reported ease of use of bespoke administration device
timeFrame: Day 0
Other outcomes:
Locations:
city: Te Aro
country: New Zealand
facility: Capital Eye Specialists
state: Wellington
city: Rotorua
country: New Zealand
facility: Rotorua Eye Clinic
Study officials:
affiliation: Capital Eye Specialists
name: Tony Wells, MD
role: PRINCIPAL_INVESTIGATOR
References: