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

Allergan220 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

220

Conditions

Open-angle Glaucoma Ocular Hypertension

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (39)

Outcomes

Primary Outcomes

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.

Time frame: Baseline to Month 6

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline to Month 18

Data from ClinicalTrials.gov

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Angeles Eye Institute /ID# 240368

Culver City, California, United States

Hamilton Glaucoma Center Shiley Eye Center UCSD /ID# 240364

La Jolla, California, United States

American Institute of Research /ID# 247820

Los Angeles, California, United States

North Bay Eye Associates Inc. /ID# 240362

Petaluma, California, United States

Pacific Eye Associates /ID# 240536

San Francisco, California, United States

Colorado Eye Institute /ID# 240798

Colorado Springs, Colorado, United States

ICON Eye Care /ID# 240681

Grand Junction, Colorado, United States

Eye Associates of Fort Meyers /ID# 244476

Fort Myers, Florida, United States

MedEye Associates /ID# 240374

Miami, Florida, United States

Center for Sight - Sarasota /ID# 244578

Sarasota, Florida, United States

...and 29 more locations

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: Baseline to Month 4

Proportion of treated eyes achieving qualified success

Time frame: Baseline to Month 6

Proportion of treated eyes achieving qualified success

Time frame: Baseline to Month 9

Proportion of treated eyes achieving qualified success

Time frame: 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).

Time frame: Baseline to Month 18

Number of participants experiencing treatment emergent adverse events

Time frame: Baseline to Month 18