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

NCT06964191 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-06-13

No results posted yet for this study

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

Interventions

COMBINATION_PRODUCT

PA5108 Ocular Implant low dose

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

COMBINATION_PRODUCT

PA5108 Ocular Implant, high dose

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

DRUG

Latanoprost 0.005% Ophthalmic Solution

Latanoprost eye drops at a concentration of 0.005%

Sponsors & Collaborators

  • IUVO S.r.l.

    collaborator INDUSTRY

  • PolyActiva Pty Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2026-11-15
Completion
2026-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06964191 on ClinicalTrials.gov