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

NCT ID: NCT00314158

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

523 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-01-31

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

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 twice daily in each study eye for six months

Brinzolamide

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

One drop twice daily in each study eye for six months

Timolol

Group Type ACTIVE_COMPARATOR

Timolol 5 mg/ml eye drops, solution

Intervention Type DRUG

One drop twice daily in each study eye for six months

Interventions

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

One drop twice daily in each study eye for six months

Intervention Type DRUG

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

One drop twice daily in each study eye for six months

Intervention Type DRUG

Timolol 5 mg/ml eye drops, solution

One drop twice daily in each study eye for six months

Intervention Type DRUG

Other Intervention Names

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AZOPT

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* Diagnosis of open-angle glaucoma

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

Locations

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United States Investigative Sites

Fort Worth, Texas, United States

Site Status

Countries

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United States

References

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Kaback M, Scoper SV, Arzeno G, James JE, Hua SY, Salem C, Dickerson JE, Landry TA, Bergamini MV; Brinzolamide 1%/Timolol 0.5% Study Group. Intraocular pressure-lowering efficacy of brinzolamide 1%/timolol 0.5% fixed combination compared with brinzolamide 1% and timolol 0.5%. Ophthalmology. 2008 Oct;115(10):1728-34, 1734.e1-2. doi: 10.1016/j.ophtha.2008.04.011. Epub 2008 Jun 5.

Reference Type RESULT
PMID: 18538406 (View on PubMed)

Other Identifiers

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C-05-24

Identifier Type: -

Identifier Source: org_study_id

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