A Safety and Efficacy Study of Bimatoprost 0.01% in Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH)

NCT ID: NCT01594970

Last Updated: 2014-01-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-01-31

Brief Summary

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This study will evaluate the safety and efficacy of bimatoprost 0.01% in subjects with elevated intraocular pressure (IOP) due to primary open-angle glaucoma (POAG) or ocular hypertension (OH).

Detailed Description

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Conditions

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Glaucoma, Open-Angle Ocular Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Bimatoprost 0.01% (Naive Monotherapy)

1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.

Group Type EXPERIMENTAL

Bimatoprost 0.01%

Intervention Type DRUG

1 drop in the affected eye(s), administered in the evening for 12 weeks.

Bimatoprost 0.01% (Switched Monotherapy)

1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.

Group Type EXPERIMENTAL

Bimatoprost 0.01%

Intervention Type DRUG

1 drop in the affected eye(s), administered in the evening for 12 weeks.

Bimatoprost 0.01% (with Adjunctive Therapy)

1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.

Group Type EXPERIMENTAL

Bimatoprost 0.01%

Intervention Type DRUG

1 drop in the affected eye(s), administered in the evening for 12 weeks.

Interventions

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Bimatoprost 0.01%

1 drop in the affected eye(s), administered in the evening for 12 weeks.

Intervention Type DRUG

Other Intervention Names

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LUMIGAN® 0.01%

Eligibility Criteria

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Inclusion Criteria

* Elevated IOP due to either primary open-angle glaucoma or ocular hypertension

Exclusion Criteria

* None
Minimum Eligible Age

20 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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Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Park KH, Simonyi S, Kim CY, Sohn YH, Kook MS. Bimatoprost 0.01% in treatment-naive patients with open-angle glaucoma or ocular hypertension: an observational study in the Korean clinical setting. BMC Ophthalmol. 2014 Dec 17;14:160. doi: 10.1186/1471-2415-14-160.

Reference Type DERIVED
PMID: 25519810 (View on PubMed)

Other Identifiers

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APMA-001211

Identifier Type: -

Identifier Source: org_study_id

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