Safety and Efficacy of Bimatoprost Compared With Latanoprost in Patients With Glaucoma or Ocular Hypertension

NCT ID: NCT00541242

Last Updated: 2011-10-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

586 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-08-31

Brief Summary

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The study will compare the safety and efficacy of Bimatoprost and Latanoprost in patients with glaucoma or ocular hypertension

Detailed Description

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Conditions

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Ocular Hypertension Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

bimatoprost 0.03% eye drops

Group Type ACTIVE_COMPARATOR

bimatoprost 0.03% eye drops

Intervention Type DRUG

Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of bimatoprost 0.03% 1 drop every evening for 12 weeks

2

latanoprost 0.005% eye drops

Group Type ACTIVE_COMPARATOR

latanoprost 0.005% eye drops

Intervention Type DRUG

Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of latanoprost 0.005% 1 drop every evening for 12 weeks

Interventions

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bimatoprost 0.03% eye drops

Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of bimatoprost 0.03% 1 drop every evening for 12 weeks

Intervention Type DRUG

latanoprost 0.005% eye drops

Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of latanoprost 0.005% 1 drop every evening for 12 weeks

Intervention Type DRUG

Other Intervention Names

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latanoprost = Xalatan® bimatoprost = Lumigan® Xalatan®

Eligibility Criteria

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Inclusion Criteria

* Ocular hypertension or chronic glaucoma
* Patient requires IOP-lowering therapy in both eyes

Exclusion Criteria

* Uncontrolled medical conditions
* Hypersensitivity to study medications
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Newport Beach, California, United States

Site Status

Countries

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United States

Other Identifiers

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192024-034

Identifier Type: -

Identifier Source: org_study_id