Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimatoprost intracameral implant (DURYSTA) 10μg | Patients with OAG or OHT who are scheduled for intracameral administration of a bimatoprost intracameral implant by their ophthalmologist. |
Not provided
| 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 |
| 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 |
Not provided
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.
Not provided
Not provided
Not provided
The study population will include US patients with OAG or OHT who are scheduled for administration of a bimatoprost intracameral implant by their ophthalmologist.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| ALLERGAN INC. | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Angeles Eye Institute /ID# 240368 | Culver City | California | 90232 | United States | ||
| Hamilton Glaucoma Center Shiley Eye Center UCSD /ID# 240364 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39946034 | Derived | Mann E, Kammer JA, Sawhney G, An J, Werts EC, Vera V, Rivas M, Lai H, Sonparote S, Craven ER. Prospective 18-Month Study of Bimatoprost Intracameral Implant in Patients with Open-Angle Glaucoma or Ocular Hypertension in US Clinical Practice. Drugs. 2025 Mar;85(3):397-414. doi: 10.1007/s40265-025-02157-1. Epub 2025 Feb 13. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| La Jolla |
| California |
| 92093 |
| United States |
| American Institute of Research /ID# 247820 | Los Angeles | California | 90027 | United States |
| North Bay Eye Associates Inc. /ID# 240362 | Petaluma | California | 94954-2387 | United States |
| Pacific Eye Associates /ID# 240536 | San Francisco | California | 94115 | United States |
| Colorado Eye Institute /ID# 240798 | Colorado Springs | Colorado | 80924-7003 | United States |
| ICON Eye Care /ID# 240681 | Grand Junction | Colorado | 81501-8180 | United States |
| Eye Associates of Fort Meyers /ID# 244476 | Fort Myers | Florida | 33901 | United States |
| MedEye Associates /ID# 240374 | Miami | Florida | 33143 | United States |
| Center for Sight - Sarasota /ID# 244578 | Sarasota | Florida | 34239 | United States |
| Newsom Eye & Laser Center /ID# 253287 | Sebring | Florida | 33870 | United States |
| Dr. Andrew Gardner Logan, FL /ID# 240361 | Tamarac | Florida | 33321 | United States |
| Your Eye Specialists /ID# 253286 | Weston | Florida | 33326 | United States |
| Georgia Eye Partners /ID# 240061 | Atlanta | Georgia | 30342 | United States |
| Kovach Eye Institute /ID# 244581 | Elmhurst | Illinois | 60126-2821 | United States |
| Stiles Eyecare Excellence /ID# 240376 | Overland Park | Kansas | 66213 | United States |
| The Eye Care Institute /ID# 240367 | Louisville | Kentucky | 40206 | United States |
| John Hopkins Wilmer Eye Institute /ID# 243701 | Bethesda | Maryland | 20817-1805 | United States |
| Midwest Vision Research Foundation at Pepose Vision Institute /ID# 240537 | Chesterfield | Missouri | 63017 | United States |
| Wiles Eye Center /ID# 240808 | Kansas City | Missouri | 64118-4390 | United States |
| Ophthalmology Associates /ID# 240799 | St Louis | Missouri | 63131 | United States |
| Eye Associates of North Jersey /ID# 244585 | Dover | New Jersey | 07801-1629 | United States |
| Hudson Eye /ID# 240805 | Jersey City | New Jersey | 07306-2929 | United States |
| Glaucoma Care Center /ID# 252021 | Livingston | New Jersey | 07039 | United States |
| Burlington County Eye Physicians /ID# 244594 | Willingboro | New Jersey | 08046-1109 | United States |
| MaculaCare PLLC /ID# 244593 | New York | New York | 10021 | United States |
| New York New Jersey Eye Institute /ID# 244590 | Orangeburg | New York | 10962-2185 | United States |
| New York Eye Surgery Associates, PLLC /ID# 244592 | The Bronx | New York | 10469 | United States |
| Duke Eye Center /ID# 244478 | Durham | North Carolina | 27705 | United States |
| Bergstrom Eye Research LLC /ID# 240363 | Fargo | North Dakota | 58103 | United States |
| META Medical Research Institute, LLC /ID# 240800 | Dayton | Ohio | 45432-1400 | United States |
| Oklahoma Eye Surgeons /ID# 240373 | Oklahoma City | Oklahoma | 73112 | United States |
| Scott and Christie and Associates /ID# 244574 | Cranberry Township | Pennsylvania | 16066 | United States |
| Vanderbilt University Medical Center /ID# 244577 | Nashville | Tennessee | 37232-0011 | United States |
| Glaucoma Associates of Texas /ID# 240682 | Dallas | Texas | 75231 | United States |
| Glaucoma Associates of Texas /ID# 253289 | Dallas | Texas | 75231 | United States |
| El Paso Eye Surgeons, P.A. /ID# 240366 | El Paso | Texas | 79902 | United States |
| DCT Shah Eye Research Institut /ID# 240375 | Mission | Texas | 78572 | United States |
| The Eye Centers of Racine and Kenosha LTD /ID# 240059 | Racine | Wisconsin | 53405 | United States |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
Not provided
Not provided