Last updated: April 11, 2024
Sponsor: PolyActiva Pty Ltd
Overall Status: Completed
Phase
1
Condition
Vascular Diseases
Open Angle Glaucoma
Ocular Hypertension
Treatment
100ng/day PA5346 Latanoprost FA SR Ocular Implant
Clinical Study ID
NCT05333419
LATA-CS103
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Have given written informed consent before any study-related activities are carriedout and must be able to understand the full nature and purpose of the trial, includingpossible risks and adverse effects.
- Diagnosis of OAG or OHT. Iridocorneal angle must be classified as Grade 3 or 4 on themodified Shaffer-Etienne scale by gonioscopy.
- Unmedicated (post-washout) 8:00 AM IOP of 24 mmHg to 36 mmHg in the ITT eye at eitherof two qualification visits 2 weeks apart. In addition, the IOP at 12:00 noon and 4:00PM must be 20 mmHg to 36 mmHg on the same qualification visit where the 8:00 AM IOPwas IOP 24 mmHg to 36 mmHg.
- Have a corrected visual acuity as determined by Early Treatment of DiabeticRetinopathy 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 asdetermined by the reading centre adopted for the study.
- Currently managing their OAG or OHT with IOP lowering drop therapy, including aprostaglandin analogue.
- Are able and willing to follow study instructions and adhere to the protocol scheduleand restrictions and undergo eye examinations
Exclusion
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 withinthe past 6 months or anticipate a need for eye surgery (including laser) in the studyeye 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, orpolytriazole 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 studyeye or have confluent central corneal guttatae, multiple central guttatae greater thana single cell, or corneal disease or abnormality that would prevent specularmicroscopy 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).
Study Design
Total Participants: 1
Treatment Group(s): 1
Primary Treatment: 100ng/day PA5346 Latanoprost FA SR Ocular Implant
Phase: 1
Study Start date:
March 04, 2022
Estimated Completion Date:
September 30, 2023
Study Description
Connect with a study center
Capital Eye Specialists
Te Aro, Wellington 6011
New ZealandSite Not Available
Rotorua Eye Clinic
Rotorua, 3015
New ZealandSite Not Available
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