A Study of a Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

Alcon

Status and phase: Completed; Phase 3

Conditions: Open-angle Glaucoma; Ocular Hypertension

Treatments: Drug: Timolol 5 mg/ml eye drops, solution; Drug: Brinzolamide 10 mg/ml (AZOPT) eye drops, suspension; Drug: Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT00314158

C-05-24

Details and patient eligibility

About

The purpose of this study is to determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension.

Enrollment: 523 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• Diagnosis of open-angle glaucoma
• Other protocol-defined inclusion criteria may apply

Exclusion criteria

• Under 18
• Pregnant
• Other protocol-defined exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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523 participants in 3 patient groups

Brinzolamide +Timolol

Experimental group

Treatment:

Drug: Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension

Brinzolamide

Active Comparator group

Treatment:

Drug: Brinzolamide 10 mg/ml (AZOPT) eye drops, suspension

Timolol

Active Comparator group

Treatment:

Drug: Timolol 5 mg/ml eye drops, solution