Ocular Hypertension, Open-angle Glaucoma
Conditions
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).
Interventions
None listed
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 the predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy | Baseline to Month 4 | 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 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 not receiving additional IOP-lowering intervention/therapy per standard medical care | Baseline to Month 4 | 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 4 | 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 4 | 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 | — |
| Mean reduction in the number of topical IOP-lowering medications | Baseline to Month 4 | A numerical count by class of drug of topical IOP lowering medications being taken. |
Countries
United States
Outcome results
None listed