RecruitingPhase 1ACTRN12621001718831

Phase I study of a Latanoprost Ocular Implant for treatment of Open Angle Glaucoma or Ocular Hypertension.

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.

Sponsor

PolyActiva Pty Ltd

Enrollment

6 participants

Start Date

Dec 20, 2021

Study Type

Interventional

Conditions

Open Angle Glaucoma Ocular Hypertension

Summary

A multi centre, open label study to assess the safety and tolerability of PA5346 ocular implant in adults who have Open Angle Glaucoma or Ocular Hypertension. Participants who are currently administering Intraocular Pressure lowering drop therapy for Open Angle Glaucoma or Ocular Hypertension will be recruited. Drop therapy will cease in the treatment eye and continue in the contralateral eye. The treated eye will receive, via injection, a single PA5346 ocular implant. Participants will be monitored for safety and tolerability of the ocular implant until it completely biodegrades.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria7

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 Criteria10

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).

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Interventions

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. The implant has been designed to slowly disappear (naturally breakdown and be reabsorbed back into the body), so there is no need for it to be removed. If the implant is proven to work effectively, it could significantly improve the treatment of glaucoma by substituting for eye drops to control the pressure in the eye, and ensure the patient always receives the daily dose of latanoprost free acid that they need. All administrations of the ocular implant will be undertaken by a qualified and trained ophthalmologist.