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Study of a Latanoprost Ocular Implant for Treatment of Open Angle Glaucoma or Ocular Hypertension. | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT05333419•PolyActiva Pty Ltd

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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).

Locations (2)

Capital Eye Specialists

Te Aro, Wellington Region, New Zealand

Rotorua Eye Clinic

Rotorua, New Zealand

Key Dates

Start Date

March 4, 2022

Primary Completion Date

June 12, 2023

Completion Date

September 30, 2023

Last Updated

April 12, 2024

Enrollment

ACTUAL participants

Conditions

Open Angle GlaucomaOcular Hypertension

Interventions

100ng/day PA5346 Latanoprost FA SR Ocular Implant

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of a Latanoprost Ocular Implant for Treatment of Open Angle Glaucoma or Ocular Hypertension.

Inclusion Criteria

Exclusion Criteria

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