Evaluate Efficacy and Safety of PA5108 Ocular Implants in Primary Open Angle Glaucoma or Ocular Hypertension

NCT06964191 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: LATA-CS201
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to determine the dose of PA5108 Ocular Implant that is effective and safe for the reduction of intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension, compared to the standard treatment therapy.

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Outcome Measures

Primary Outcomes (4)

• Efficacy: change in mean diurnal intraocular pressure in study eye

  From Baseline to 12 weeks

• Incidence of ocular symptoms and ocular treatment-emergent adverse events.

  Ocular safety and tolerability (AEs)

  Day 1 to study completion until at least Week 58

• Clinically significant change on slit-lamp exam

  Slit-lamp biomicroscopy of eye to observe clinically significant changes.

  Day 1 to study completion until at least Week 58

• Clinically significant change in corneal endothelial cells

  Corneal endothelial cell density (cells/mm2) measured by specular microscopy.

  Day 1 to study completion until at least Week 58

Secondary Outcomes (1)

• Efficacy: intraocular pressure change from baseline in study eye at different diurnal time points.

  Weeks 2-52

Other Outcomes (1)

• Exploratory: Gather data on implant administration procedure and overall experience from study participants.

  At 24 and 58 weeks

Study Arms (3)

PA5108 Ocular Implant low dose

EXPERIMENTAL

PA5108 Ocular Implant, low dose in the study eye, and latanoprost ophthalmic solution 0.005% once daily pm in the other eye.

Combination Product: PA5108 Ocular Implant low dose; Drug: Latanoprost 0.005% Ophthalmic Solution

PA5108 Ocular Implant high dose

EXPERIMENTAL

PA5108 Ocular Implant, high dose in the study eye, and latanoprost ophthalmic solution 0.005% once daily pm in the other eye.

Combination Product: PA5108 Ocular Implant, high dose; Drug: Latanoprost 0.005% Ophthalmic Solution

Latanoprost ophthalmic solution 0.005%

ACTIVE COMPARATOR

Latanoprost ophthalmic solution 0.005% once daily pm in both eyes.

Drug: Latanoprost 0.005% Ophthalmic Solution

Interventions

PA5108 Ocular Implant low dose COMBINATION_PRODUCT

The PA5108 Ocular Implant low dose is supplied preloaded into the needle of a single use administration device ready for use.

PA5108 Ocular Implant low dose

PA5108 Ocular Implant, high dose COMBINATION_PRODUCT

The PA5108 Ocular Implant high dose is supplied preloaded into the needle of a single use administration device ready for use.

PA5108 Ocular Implant high dose

Latanoprost 0.005% Ophthalmic Solution DRUG

Latanoprost eye drops at a concentration of 0.005%

Latanoprost ophthalmic solution 0.005%; PA5108 Ocular Implant high dose; PA5108 Ocular Implant low dose

Eligibility Criteria

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

You may qualify if:

• Ability to provide informed consent and follow study instructions
• years of age or older
• Diagnosis of open-angle glaucoma or ocular hypertension in both eyes
• Qualifying IOPs across 2 visits following washout of IOP-lowering medication, if applicable
• Qualifying best-corrected visual acuity BCVA using Early Treatment Diabetic Retinopathy Study (ETDRS) chart in study eye
• Qualifying corneal endothelial cell density (CEDC) in the study eye

You may not qualify if:

• Pseudoexfoliation or pigment dispersion, narrow irido-corneal drainage angles, or existing peripheral anterior synechiae in the inferior angle either eye.
• Advanced or severe glaucoma
• Disqualifying central corneal thickness in either eye
• Significant other ocular conditions that could prevent accurate assessment of IOP and corneal health
• Uncontrolled medical conditions
• Have previously received, any injectable glaucoma medication into the anterior chamber of the study eye
• Have received intravitreal injections in the study eye within the last 3 months of the Screening Visit and anticipated need for an intravitreal injection during the course of the study
• Unwilling or unable to discontinue, in either eye, soft contact lens wear at least 2 days and hard contact lens wear 1 week before scheduled study visits and on implant administration days

Sponsors & Collaborators

• PolyActiva Pty Ltd: lead
• IUVO S.r.l.: collaborator

Study Sites (1)

Eye Research Foundation

Newport Beach, California, 92663, United States

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Latanoprost; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Central Study Contacts

Vanessa Waddell

CONTACT

+61 3 9020 3565; vanessa.waddell@polyactiva.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the study design, the product and the treatment arms, neither the study Investigator nor participant can be completely masked as to the treatment being administered. The participant will be aware of randomization to either an ocular implant or eye drops but will remain masked as to the strength of implant administered. The Investigator and implant administration personnel will be unmasked and be able to determine which strength of implant has been administered due to the size of the implant. Intraocular pressure assessments and certain safety assessments should be observer masked to the extent possible. Study personnel/technicians performing some study assessments will be masked to the treatment randomization to the extent possible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: May 9, 2025
• Study Start: May 31, 2025
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)