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

NCT ID: NCT00314171

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

437 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2007-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Open-angle Glaucoma Ocular Hypertension

Keywords

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open-angle glaucoma ocular hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Brinzolamide + Timolol

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Dorzolamide + Timolol

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Interventions

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

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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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COSOPT

Eligibility Criteria

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Inclusion Criteria

* 18 years or older
* Diagnosis of open-angle glaucoma or ocular hypertension

Exclusion Criteria

* Under 18
* Pregnant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Countries

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United States

References

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Manni G, Denis P, Chew P, Sharpe ED, Orengo-Nania S, Coote MA, Laganovska G, Volksone L, Zeyen T, Filatori I, James J, Aung T. The safety and efficacy of brinzolamide 1%/timolol 0.5% fixed combination versus dorzolamide 2%/timolol 0.5% in patients with open-angle glaucoma or ocular hypertension. J Glaucoma. 2009 Apr-May;18(4):293-300. doi: 10.1097/IJG.0b013e31818fb434.

Reference Type RESULT
PMID: 19365194 (View on PubMed)

Other Identifiers

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C-05-10

Identifier Type: -

Identifier Source: org_study_id