18 Month Prospective Efficacy and Safety Study of Bimatoprost Intracameral Implant (DURYSTA)

Study Overview
=================
Brief Summary
-----------------
Study to collect effectiveness and safety data after administration of a bimatoprost intracameral implant in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Official Title
-----------------
ARGOS - A Phase IV, Prospective, 18-month Study to Assess the Effectiveness and Safety of Bimatoprost Intracameral Implant (DURYSTA) in US Clinical Practice

Conditions
-----------------
Open-angle Glaucoma, Ocular Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patient diagnosed with OAG or OHT who is scheduled to receive a bimatoprost intracameral implant in at least one eye. Exclusion Criteria: - A history of any of the following ocular surgeries in the eye due to receive a bimatoprost intracameral implant:Ahmed Glaucoma Valve, Baerveldt shunt, Ex-Press glaucoma shunt implantation, Molteno shunt, Trabeculectomy, Vitrectomy, retinal surgery, CyPass Micro-Stent or Anterior Chamber Intraocular Lens (AC IOL) placement. Concurrent or anticipated enrollment in an interventional clinical trial involving either an investigational medicinal product or medical device. Previous enrollment in another Allergan bimatoprost intracameral implant study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bimatoprost intracameral implant (DURYSTA) 10μg<br>Patients with OAG or OHT who are scheduled for intracameral administration of a bimatoprost intracameral implant by their ophthalmologist. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of treated eyes that did not receive additional Intraocular Pressure (IOP) -lowering intervention/therapy per standard medical care | IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. | Baseline to Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of treated eyes not receiving additional IOP-lowering intervention/therapy per standard medical care | IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. | Baseline to Month 4 | 
| Proportion of treated eyes not receiving additional IOP-lowering intervention/therapy per standard medical care | IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. | Baseline to Month 9 | 
| Proportion of treated eyes not receiving additional IOP-lowering intervention/therapy per standard medical care | IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. | Baseline to Month 12 | 
| Proportion of treated eyes not receiving additional IOP-lowering intervention/therapy per standard medical care | IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. | Baseline to Month 18 | 
| Time from bimatoprost intracameral implant to first additional IOP-lowering intervention/therapy | Time to first IOP-lowering intervention is defined as the time between treatment and IOP-lowering intervention. | Baseline to Month 18 | 
| Proportion of treated eyes achieving the predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy | IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. | Baseline to Month 4 | 
| Proportion of treated eyes achieving the predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy | IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. | Baseline to Month 6 | 
| Proportion of treated eyes achieving the predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy | IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. | Baseline to Month 9 | 
| Proportion of treated eyes achieving the predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy | IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. | Baseline to Month 12 | 
| Proportion of treated eyes achieving predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy | IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. | Baseline to Month 18 | 
| Mean reduction in the number of topical IOP-lowering medications | A numerical count by class of drug of topical IOP lowering medications being taken. | Baseline to Month 4 | 
| Mean reduction in the number of topical IOP-lowering medications | A numerical count by class of drug of topical IOP lowering medications being taken. | Baseline to Month 6 | 
| Mean reduction in the number of topical IOP-lowering medications | A numerical count by class of drug of topical IOP lowering medications being taken. | Baseline to Month 9 | 
| Mean reduction in the number of topical IOP-lowering medications | A numerical count by class of drug of topical IOP lowering medications being taken. | Baseline to Month 12 | 
| Mean reduction in the number of topical IOP-lowering medications | A numerical count by class of drug of topical IOP lowering medications being taken. | Baseline to Month 18 | 
| Proportion of treated eyes achieving complete success | Complete success is defined as treated eyes with IOP <=18 mm Hg without any additional IOP lowering interventions/therapies after administration of the bimatoprost intracameral implant. | Baseline to Month 4 | 
| Proportion of treated eyes achieving complete success | Complete success is defined as treated eyes with IOP <=18 mm Hg without any additional IOP lowering interventions/therapies after administration of the bimatoprost intracameral implant. | Baseline to Month 6 | 
| Proportion of treated eyes achieving complete success | Complete success is defined as treated eyes with IOP <=18 mm Hg without any additional IOP lowering interventions/therapies after administration of the bimatoprost intracameral implant. | Baseline to Month 9 | 
| Proportion of treated eyes achieving complete success | Complete success is defined as treated eyes with IOP <=18 mm Hg without any additional IOP lowering interventions/therapies after administration of the bimatoprost intracameral implant. | Baseline to Month 12 | 
| Proportion of treated eyes achieving complete success | Complete success is defined as treated eyes with IOP <=18 mm Hg without any additional IOP lowering interventions/therapies after administration of the bimatoprost intracameral implant. | Baseline to Month 18 | 
| Proportion of treated eyes achieving qualified success | Partial success is defined as treated eyes with IOP <=18 mm Hg with no Secondary Surgical Intervention (SSI) for glaucoma, while staying on the same or fewer topical IOP-lowering medications than baseline and or Selective Laser Trabeculoplasty (SLT), Argon Laser Trabeculoplasty (ALT) or MicroPulse Laser Trabeculoplasty (MLT). | Baseline to Month 4 | 
| Proportion of treated eyes achieving qualified success | Partial success is defined as treated eyes with IOP <=18 mm Hg with no Secondary Surgical Intervention (SSI) for glaucoma, while staying on the same or fewer topical IOP-lowering medications than baseline and or Selective Laser Trabeculoplasty (SLT), Argon Laser Trabeculoplasty (ALT) or MicroPulse Laser Trabeculoplasty (MLT). | Baseline to Month 6 | 
| Proportion of treated eyes achieving qualified success | Partial success is defined as treated eyes with IOP <=18 mm Hg with no Secondary Surgical Intervention (SSI) for glaucoma, while staying on the same or fewer topical IOP-lowering medications than baseline and or Selective Laser Trabeculoplasty (SLT), Argon Laser Trabeculoplasty (ALT) or MicroPulse Laser Trabeculoplasty (MLT). | Baseline to Month 9 | 
| Proportion of treated eyes achieving qualified success | Partial success is defined as treated eyes with IOP <=18 mm Hg with no Secondary Surgical Intervention (SSI) for glaucoma, while staying on the same or fewer topical IOP-lowering medications than baseline and or Selective Laser Trabeculoplasty (SLT), Argon Laser Trabeculoplasty (ALT) or MicroPulse Laser Trabeculoplasty (MLT). | Baseline to Month 12 | 
| Proportion of treated eyes achieving qualified success | Partial success is defined as treated eyes with IOP ≤18 mm Hg with no Secondary Surgical Intervention (SSI) for glaucoma, while staying on the same or fewer topical IOP-lowering medications than baseline and or Selective Laser Trabeculoplasty (SLT), Argon Laser Trabeculoplasty (ALT) or MicroPulse Laser Trabeculoplasty (MLT). | Baseline to Month 18 | 
| Number of participants experiencing treatment emergent adverse events |  | Baseline to Month 18 |