18 Month Prospective Efficacy and Safety Study of Bimatoprost Intracameral Implant (DURYSTA)
- Conditions
- Ocular HypertensionOpen-angle Glaucoma
- Registration Number
- NCT04647214
- Lead Sponsor
- Allergan
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
- Patient diagnosed with OAG or OHT who is scheduled to receive a bimatoprost intracameral implant in at least one eye.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of treated eyes that did not receive additional Intraocular Pressure (IOP) -lowering intervention/therapy per standard medical care Baseline to Month 6 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.
- Secondary Outcome Measures
Name Time Method Mean reduction in the number of topical IOP-lowering medications Baseline to Month 18 A numerical count by class of drug of topical IOP lowering medications being taken.
Proportion of treated eyes achieving the predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy Baseline to Month 12 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.
Proportion of treated eyes not receiving additional IOP-lowering intervention/therapy per standard medical care Baseline to Month 18 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 from bimatoprost intracameral implant to first additional IOP-lowering intervention/therapy Baseline to Month 18 Time to first IOP-lowering intervention is defined as the time between treatment and IOP-lowering intervention.
Proportion of treated eyes achieving predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy Baseline to Month 18 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.
Proportion of treated eyes achieving complete success Baseline to Month 18 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.
Proportion of treated eyes achieving qualified success Baseline to Month 18 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).
Number of participants experiencing treatment emergent adverse events Baseline to Month 18
Trial Locations
- Locations (39)
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
Scroll for more (29 remaining)Angeles Eye Institute /ID# 240368🇺🇸Culver City, California, United States