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| Name | Class |
|---|---|
| IUVO S.r.l. | INDUSTRY |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Latanoprost ophthalmic solution 0.005% | Active Comparator | Latanoprost ophthalmic solution 0.005% once daily pm in both eyes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: intraocular pressure change from baseline in study eye at different diurnal time points. | Weeks 2-52 |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory: Gather data on implant administration procedure and overall experience from study participants. | A questionnaire comprising two questions will be used at Week 24 and Week 58 to assess the administration procedure. | At 24 and 58 weeks |
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Research Foundation | Newport Beach | California | 92663 | United States |
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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.
| 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. |
|
| Latanoprost 0.005% Ophthalmic Solution | Drug | Latanoprost eye drops at a concentration of 0.005% |
|
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077338 | Latanoprost |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
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