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.

PolyActiva Pty Ltd0 sites6 target enrollmentDecember 16, 2021

Overview

No summary available.

Registry

who.int

Start Date

December 16, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

•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

•\- 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).