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

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

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.

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

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.

Connect with a study center

  • Capital Eye Specialists

    Te Aro, Wellington 6011
    New Zealand

    Site Not Available

  • Rotorua Eye Clinic

    Rotorua, 3015
    New Zealand

    Site Not Available

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