A Dose-Volume Study of a Treatment for Elevated IOP Due to Open-Angle Glaucoma or Ocular Hypertension
Phase 2
Terminated
- Conditions
- Open-Angle GlaucomaOcular Hypertension
- Interventions
- Registration Number
- NCT00788541
- Lead Sponsor
- Alcon Research
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 197
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 exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 48 mg Anecortave Acetate, low volume high dose Anecortave Acetate Sterile Suspension, 96 mg/mL Anecortave Acetate Sterile Suspension, 96 mg/mL, one injection of 0.5 mL in the study eye monthly for 6 months. 48 mg Anecortave Acetate, high volume low dose Anecortave Acetate Sterile Suspension, 60 mg/ML Anecortave Acetate Sterile Suspension, 60 mg/mL, one injection of 0.8 mL in the study eye monthly for 6 months. 3 mg Anecortave Acetate, low volume high dose Anecortave Acetate Sterile Suspension, 6 mg/mL Anecortave Acetate Sterile Suspension, 6 mg/mL, one injection of 0.5 mL in the study eye monthly for 6 months. 3 mg Anecortave Acetate, high volume low dose Anecortave Acetate Sterile Suspension, 3.75 mg/mL Anecortave Acetate Sterile Suspension, 3.75 mg/mL, one injection of 0.8 mL in the study eye monthly for 6 months. Anecortave Acetate Vehicle, low volume Anecortave Acetate Vehicle Anecortave Acetate Vehicle, one injection of 0.5 mL in the study eye monthly for 6 months. Anecortave Acetate Vehicle, high volume Anecortave Acetate Vehicle Anecortave Acetate Vehicle, one injection of 0.8 mL in the study eye monthly for 6 months.
- Primary Outcome Measures
Name Time Method Mean Intraocular Pressure 6 months
- Secondary Outcome Measures
Name Time Method Percent of patients who remain rescue-medication free 6 Months
Trial Locations
- Locations (1)
Contact Alcon Call Center For Trial Locations
🇺🇸Fort Worth, Texas, United States