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

Sponsor

Alcon Research (Industry)

Overall Status

Completed

CT.gov ID

NCT00314171

Collaborator

(none)

437

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Open-angle Glaucoma Ocular Hypertension	Drug: Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension Drug: Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (COSOPT)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

437 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2005

Actual Primary Completion Date :

Aug 1, 2007

Actual Study Completion Date :

Aug 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Brinzolamide + Timolol	Drug: Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension One drop in the study eye(s) twice daily for 12 months
Active Comparator: Dorzolamide + Timolol	Drug: Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (COSOPT) One drop in the study eye(s) twice daily for 12 months Other Names: COSOPT

Arm

Intervention/Treatment

Experimental: Brinzolamide + Timolol

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

One drop in the study eye(s) twice daily for 12 months

Active Comparator: Dorzolamide + Timolol

Drug: Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (COSOPT)

One drop in the study eye(s) twice daily for 12 months

Other Names:

COSOPT