Ocular Hypertension, Open-Angle Glaucoma
Conditions
Keywords
Open-Angle Glaucoma, Intraocular Pressure, Anecortave Acetate
Brief summary
The purpose of this study was to assess the effects of total volume and total dose on the safety and intraocular pressure-lowering efficacy of Anecortave Acetate Suspension (3 mg and 48 mg) in 0.5 mL and 0.8 mL volumes when administered by anterior juxtascleral depot (AJD) for the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Interventions
Administered as an injection into an anterior juxtascleral depot
DRUGAnecortave Acetate Sterile Suspension, 3.75 mg/mL
Administered as an injection into an anterior juxtascleral depot
DRUGAnecortave Acetate Sterile Suspension, 96 mg/mL
Administered as an injection into an anterior juxtascleral depot
Administered as an injection into an anterior juxtascleral depot
Administered as an injection into an anterior juxtascleral depot
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of Open-Angle Glaucoma or Ocular Hypertension for at least 6 months; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Prior angle surgery in the study eye, severe visual field loss in either eye; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Intraocular Pressure | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Percent of patients who remain rescue-medication free | 6 Months |
Countries
United States
Outcome results
None listed