Glaucoma, Open-Angle, Ocular Hypertension
Conditions
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.
Detailed description
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.
Interventions
COMBINATION_PRODUCTPA5108 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_PRODUCTPA5108 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.
Latanoprost eye drops at a concentration of 0.005%
Sponsors
IUVO S.r.l.
PolyActiva Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key 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 Key
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Day 1 to study completion until at least Week 58 | Ocular safety and tolerability (AEs) |
| Clinically significant change on slit-lamp exam | Day 1 to study completion until at least Week 58 | Slit-lamp biomicroscopy of eye to observe clinically significant changes. |
| Clinically significant change in corneal endothelial cells | Day 1 to study completion until at least Week 58 | Corneal endothelial cell density (cells/mm2) measured by specular microscopy. |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: intraocular pressure change from baseline in study eye at different diurnal time points. | Weeks 2-52 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory: Gather data on implant administration procedure and overall experience from study participants. | At 24 and 58 weeks | A questionnaire comprising two questions will be used at Week 24 and Week 58 to assess the administration procedure. |
Countries
United States
Contacts
Primary ContactVanessa Waddell
Outcome results
None listed