Status:
COMPLETED
Study of a Latanoprost Ocular Implant for Treatment of Open Angle Glaucoma or Ocular Hypertension.
Lead Sponsor:
PolyActiva Pty Ltd
Conditions:
Open Angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 me...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2023
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT05333419
Start Date
March 4 2022
End Date
September 30 2023
Last Update
April 12 2024
Active Locations (2)
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1
Capital Eye Specialists
Te Aro, Wellington Region, New Zealand, 6011
2
Rotorua Eye Clinic
Rotorua, New Zealand, 3015