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

NCT05333419 | Completed Phase 1 DMC

• 1 other identifier: LATA-CS103
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

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.

Conditions

Open Angle Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (6)

• To assess the safety and tolerability of 100 ng/day PA5346 Latanoprost FA SR Ocular Implant in adults with Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT).

  Clinically significant changes to haematology or biochemistry

  Change from baseline to 40 weeks

• To assess the safety and tolerability of 100 ng/day PA5346 Latanoprost FA SR Ocular Implant in adults with Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT).

  Clinically significant changes to urinalysis

  Change from baseline to 40 weeks

• To assess the safety and tolerability of 100 ng/day PA5346 Latanoprost FA SR Ocular Implant in adults with Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT).

  Clinically significant changes to physical examination

  Change from baseline to 40 weeks

• To assess the safety and tolerability of 100 ng/day PA5346 Latanoprost FA SR Ocular Implant in adults with Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT).

  Clinically significant changes to vital signs

  Change from baseline to 40 weeks

• To assess the safety and tolerability of 100 ng/day PA5346 Latanoprost FA SR Ocular Implant in adults with Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT).

  Clinically significant changes to visual acuity

  Change from baseline to 40 weekls

• To assess the period of biodegradation of 100 ng/day PA5346 Latanoprost FA SR Ocular Implant in adults with OAG or OHT.

  Biodegradation will be assessed by Gonioscopy or anterior Optical Coherence at Tomography (OCT) at Weeks 6, 12, 18, 26, 34, 40 and each subsequent 6 week visit thereafter until the implant has completely biodegraded. These tests allow the implant to be located by the ophthalmologist.

  Up to 12 months

Secondary Outcomes (3)

• To assess the initial efficacy of 100 ng/day PA5346 Latanoprost FA SR Ocular Implant in controlling IOP during a study period in adults with OAG or OHT.

  Up to 12 months

• Extent of hyperaemia.

  Up to 12 months

• Ophthalmologist-reported ease of use of bespoke administration device

  Day 0

Study Arms (1)

Single Dose 100ng/day PA5346 Latanoprost FA SR Ocular Implant

EXPERIMENTAL

After washout, eligible subjects will be dosed with a single 100ng/day PA5346 Latanoprost FA SR Ocular Implant at study Day 0.

Drug: 100ng/day PA5346 Latanoprost FA SR Ocular Implant

Interventions

100ng/day PA5346 Latanoprost FA SR Ocular Implant DRUG

PA5346 ocular implant is a small, clear rod-shaped implant that is placed in the anterior (front) chamber of the eye, at a single timepoint, and slowly releases a drug called latanoprost free acid (100ng/day) over a period of approximately 30 weeks

Single Dose 100ng/day PA5346 Latanoprost FA SR Ocular Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• PolyActiva Pty Ltd: lead

Study Sites (2)

Capital Eye Specialists

Te Aro, Wellington Region, 6011, New Zealand

Location

Rotorua Eye Clinic

Rotorua, 3015, New Zealand

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Study Officials

• Tony Wells, MD

  Capital Eye Specialists

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: April 19, 2022
• Study Start: March 4, 2022
• Primary Completion: June 12, 2023
• Study Completion: September 30, 2023
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (2)