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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-31

Study Completion Date

2026-11-15

Brief Summary

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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.

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Detailed Description

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This is a randomised, parallel, masked, active-controlled study that will evaluate the efficacy and safety of a low dose and a high dose of PA5108 Ocular Implant with single redosing during the study, in adults with open-angle glaucoma or ocular hypertension.

The study will also collect information on the implant administration procedure and overall experience from study participants.

The study plans to recruit approximately 75 participants.

Eligible participants will be randomly selected to receive one of the following treatments:

* PA5108 Ocular Implant - low dose in the study eye, and Latanoprost 0.005% eye drops in the other eye
* PA5108 Ocular Implant - high dose in the study eye, and Latanoprost 0.005% eye drops in the other eye
* Latanoprost 0.005% eye drops in both eyes (control treatment group) If allocated to receive either of the ocular implants, a second implant of the same dose will be administered at 26 weeks and participants will be followed for safety and intraocular pressure control until week 58 or until the implant is no longer visible in the study eye.

Conditions

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Glaucoma, Open-Angle Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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PA5108 Ocular Implant low dose

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

Group Type EXPERIMENTAL

PA5108 Ocular Implant low dose

Intervention Type COMBINATION_PRODUCT

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

Latanoprost 0.005% Ophthalmic Solution

Intervention Type DRUG

Latanoprost eye drops at a concentration of 0.005%

PA5108 Ocular Implant high dose

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

Group Type EXPERIMENTAL

PA5108 Ocular Implant, high dose

Intervention Type COMBINATION_PRODUCT

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

Latanoprost 0.005% Ophthalmic Solution

Intervention Type DRUG

Latanoprost eye drops at a concentration of 0.005%

Latanoprost ophthalmic solution 0.005%

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

Group Type ACTIVE_COMPARATOR

Latanoprost 0.005% Ophthalmic Solution

Intervention Type DRUG

Latanoprost eye drops at a concentration of 0.005%

Interventions

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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.

Intervention Type 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.

Intervention Type COMBINATION_PRODUCT

Latanoprost 0.005% Ophthalmic Solution

Latanoprost eye drops at a concentration of 0.005%

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Ability to provide informed consent and follow study instructions
* 18 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No