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

Sponsor

Alcon Research (Industry)

Overall Status

Completed

CT.gov ID

NCT00314158

Collaborator

(none)

523

Enrollment

Location

Arms

Duration (Months)

37.4

Patients Per Site Per Month

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: Brinzolamide 10 mg/ml (AZOPT) eye drops, suspension Drug: Timolol 5 mg/ml eye drops, solution	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

523 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Study Start Date :

Nov 1, 2005

Actual Primary Completion Date :

Jan 1, 2007

Actual Study Completion Date :

Jan 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 twice daily in each study eye for six months
Active Comparator: Brinzolamide	Drug: Brinzolamide 10 mg/ml (AZOPT) eye drops, suspension One drop twice daily in each study eye for six months Other Names: AZOPT
Active Comparator: Timolol	Drug: Timolol 5 mg/ml eye drops, solution One drop twice daily in each study eye for six months

Arm

Intervention/Treatment

Experimental: Brinzolamide +Timolol

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

One drop twice daily in each study eye for six months

Active Comparator: Brinzolamide

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

One drop twice daily in each study eye for six months

Other Names:

AZOPT

Active Comparator: Timolol

Drug: Timolol 5 mg/ml eye drops, solution

One drop twice daily in each study eye for six months

Outcome Measures

Primary Outcome Measures

Mean intra-ocular pressure (IOP) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	United States Investigative Sites	Fort Worth	Texas	United States	76134

Sponsors and Collaborators

Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alcon Research

ClinicalTrials.gov Identifier:

NCT00314158

Other Study ID Numbers:

C-05-24

First Posted:

Apr 13, 2006

Last Update Posted:

Nov 18, 2016

Last Verified:

Mar 1, 2012

Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2016